AMMI Annual Report 2016

Table of Contents



Chairman’s Message 2


About AMMI 4


Board of Directors 6


Membership 7


Full Members 8


Associate Members 12


Members’ Ac vi es 13


Government Affairs and Policy 17


Regulatory and Technical 23



Talent Development 26


News Highlights 30
















AMMI Annual Report 2016 1

HIGHLIGHTS OF 2016
The Board is pleased to report that our Associa on is
in good financial posi on.

In 2016, six (6) new companies joined AMMI, bringing
Dear AMMI Members, the total number of members to sixty-two (62). They
are Boston Scien fic Medical Device (Malaysia) Sdn.
On behalf of the Board of Directors, I am pleased to Bhd., Cochlear Malaysia Sdn. Bhd., Engineered
present to our members, the Associa on of Malaysian Medical Systems Malaysia Sdn. Bhd., Orthomedic
Medical Industries (AMMI) Annual Report for the year Innova ons Sdn. Bhd., Owen Mumford Sdn. Bhd. and
ending 31 December 2016. Plas k STC Sdn. Bhd. We hope to see more medical
device companies joining so that AMMI can truly be
The medical device industry con nues to be an area of the voice of the medical device manufacturing
growth in Malaysia. AMMI members’ cumula ve industry in Malaysia.
investments amounted to RM5.09 billion in 2015, as
compared to RM4.27 billion in 2014. The increase AMMI con nues to foster a good working rela onship
reflects investors’ confidence in the Medical Device with various government ministries and agencies. In
Industry in Malaysia. According to AMMI’s survey, July this year, AMMI had an exclusive dialogue session
members’ collec ve exports in 2015 increased by 20% with the Malaysian Investment Development
to reach RM8.3 billion, accoun ng for more than 50% Authority (MIDA) and jointly launched the AMMI
of Malaysia’s total exports of medical devices of Medical Device Industry Outlook Report 2016. The
RM15.5 billion in 2015. The survey also recorded an report is recognised as a good reference highligh ng
outstanding average value-added ra o of 60% in the status of the industry in Malaysia. It also provides
manufacturing medical devices in Malaysia. A high insights on the outlook and future prospects of the
percentage of about RM1.97 billion or 55% worth of industry in general.
raw materials and services were locally sourced from
within Malaysia. AMMI members spent a total of AMMI has been appointed the chair of MIDA’s
RM45.0 million in research & development (R&D) Medical Device Sub-Industry Working Group under its
ac vi es in 2015, propelling a gradual shi towards Industry Skills Commi ee and is also a member of
higher-value added and innova ve medical devices. MIDA’s Medical Device Investment Advisory Panel
(MDIAP). The objec ve of the forma on of MDIAP is
All this is good news for the medical device industry to strengthen the medical device manufacturing
and its stakeholders as this reinforces the country’s industry in Malaysia and to be er facilitate
standing as an ideal hub for medical device companies including SMEs to becoming strong players
manufacturing. interna onally.










2 AMMI Annual Report 2016

AMMI is also on the SME Corpora on Malaysia HIP On behalf of the Board of Directors, I would like thank
(High Impact Programme):5 Medical Device Steering all those who have supported our Associa on. The
Commi ee. The objec ve of the commi ee is to assist Associa on’s role and its contribu on to the
medical companies in cer fica on and regula on development of the medical devices industry is
support, marke ng strategy support, interna onal increasingly being recognised by government
partner search, technology roadmap development ministries and agencies such as Ministry of
and industry landscaping; and supply chain Interna onal Trade and Industry (MITI), Malaysian
management. Investment Development Authority (MIDA), Malaysia
External Trade Development Corpora on (MATRADE)
AMMI successfully organised 6 public training courses and SME Corpora on. AMMI will no doubt work hard
and trained 180 par cipants in 2016. We also with our key stakeholders and engage key decision
organised 2 HR Forums and Networking mee ngs this makers ensuring balanced policy advocacy.
year, in Penang and Kuala Lumpur. We are encouraged
by the increase in par cipa on in the HR forums and I would like to record my apprecia on to our members
hope more members will come forward to champion for their ac ve par cipa on at our mee ngs and
these forums, making them relevant and sustainable events. I am thankful to the Board of Directors for
pla orms for HR professionals. their valuable contribu on, advice and ac ve
engagement without which our Associa on would
MAIN CHALLENGES … not have progressed this far. Finally, my grateful
Besides fluctua on of currency, increase in labour thanks to the staff of Medsociate Sdn Bhd, our
cost and factors like natural gas price increase have Secretariat for rendering services professionally to the
accelerated the overall manufacturing cost. Shortage Associa on and to its members.
of skilled workforce and reten on of talent remain key
challenges in the industry. Another major challenge is
the limited access to the local public healthcare
system for our industry players.

LOOKING AHEAD…
Compe on from manufacturers in China, India and HITENDRA JOSHI
Vietnam will con nue to add pricing pressure to Chairman
medical device manufacturers in Malaysia. Despite a December 31, 2016
weaker ringgit and other extraneous factors that have
dampened the economic outlook of this country,
AMMI member companies remain bullish about
business prospects in 2017.













AMMI Annual Report 2016 3

VISION
“Establish Malaysia as the preferred global manufacturing loca on for medical technology.”


MISSION
“Promote and strengthen best in class manufacturing opera ons in Malaysia
by iden fying and promo ng appropriate processes, structures, policies and support
required to facilitate manufacturing and opera onal excellence.”



Quick Stats




Formed in 1989, the Associa on of
Malaysian Medical Industries (AMMI),
62
represents leading medical device
manufacturing companies in the medical
technology industry in Malaysia. AMMI Members
currently has 62 member companies and
collec vely, they account for more than half
of the total export revenue for “Made-in- Collectively
Malaysia” medical devices. accounted for over
51%
AMMI MEMBERS SHARE A COMMON
COMMITMENT TO QUALITY AND ARE Export for Medical
REPUTABLE INTERNATIONAL AND LOCAL Devices
FIRMS THAT STRICTLY ADHERE TO THE
QUALITY MANAGEMENT SYSTEM CODE
LAID DOWN BY GOVERNMENTAL AGENCIES. Collective export
value in 2015
AMMI companies con nue to be the growth
base of the medical device industry in RM8.3billion
Malaysia and consist of three main types of
industry players: manufacturers; suppliers of
raw materials and services to the medical
devices manufacturing companies; and Employ more than
importers and exporters of medical devices, 31,000
all of whom employ a sizable workforce in
their produc on facili es. Knowledge based
workforce





4 AMMI Annual Report 2016

AMMI Annual Report 2016 5

CHAIRMAN
MR. HITENDRA JOSHI
B. Braun Medical Industries Sdn. Bhd.




VICE-CHAIRMAN
MR LIM BEE LEONG
Bemis Asia Pacific Sdn. Bhd.





VICE-CHAIRMAN
MR JOHN WARD
SteriPack Asia Sdn. Bhd.






SECRETARY
MR CHRISTOPHE MARQUE
Stereo Sdn. Bhd.





TREASURER
MR CHIN HOCK MENG
St. Jude Medical Opera ons (M) Sdn. Bhd.
St. Jude Medical is now Abbo























DIRECTOR DIRECTOR DIRECTOR DIRECTOR
MR SUWIT MR YAP KEE KEONG DATO’ DR HAMINNUDDIN MS ONG YEAN TING
TUNLAYADECHANONT Texchem Life Sciences HJ. ABDUL HAMID Johnson & Johnson
Synergy Sterilisa on (M) Sdn. Bhd. Ideal Healthcare Sdn. Bhd.
Sdn. Bhd. (now part of STERIS) Sdn. Bhd. (un l Sept 2016)



6 AMMI Annual Report 2016

COMMITTEE LEADER:
Ÿ Mr John Ward (SteriPack Asia Sdn. Bhd.)

MEMBERS: UPGRADED TO FULL MEMBERS:
Ÿ Mr Lim Bee Leong (Bemis Asia Pacific Sdn. Bhd.) 1. Diptech Industries Sdn. Bhd.
Ÿ Mr Suwit Tunlayadechanont (Synergy Sterilisa on 2. KLS Mar n Malaysia Sdn. Bhd.
(M) Sdn. Bhd., now part of STERIS) 3. Nitritex (M) Sdn. Bhd.
Ÿ Mr Christophe Marque (Stereo Sdn. Bhd.) 4. Paramit Malaysia Sdn. Bhd.
Ÿ Mr Kevin Wong (Prent Malaysia Sdn. Bhd.) 5. Sanmina-SCI System (Malaysia) Sdn. Bhd.

NEW MEMBERS :

Boston Scien fic Medical Device (Malaysia) Sdn. Bhd.
Established in 1979, the US-based company specialises in products and technologies used to
diagnose or treat a wide range of medical condi ons, including heart, diges ve, pulmonary,
vascular, urological, pelvic health, and chronic pain condi ons. Their new facility on the 20-acre
site in the Batu Kawan Industrial Park in Penang is earmarked to begin opera ons in the fourth
quarter of 2017.

Cochlear Malaysia Sdn. Bhd.
Founded in 1981, Cochlear is an Australian based medical device company that designs,
manufactures and supplies the Nucleus cochlear implant, the Hybrid electro-acous c implant and
the Baha bone conduc on implant. Incorporated in 2010, Cochlear Malaysia is comprised of a
global service centre which provides global service & repair of sound processors and Baha, global
IT services and technical support, corporate shared services as well as procurement support.


Engineered Medical Systems Malaysia Sdn. Bhd.
Established in 1985, Engineered Medical Systems Inc. is a medical device manufacturer in
Indianapolis, Indiana. Its second plant is located in Penang, Malaysia. EMS specialises in CO2
Indicator, heat and moisture exchanger/filter, and endotraceal tubes.

Orthomedic Innova ons Sdn. Bhd.
Established in 2008, Orthomedic is one of the leading orthopaedic implants and instruments
manufacturer in Malaysia specialising in the trauma locking pla ng system.

Owen Mumford Sdn. Bhd.
Established in 1952, Owen Mumford is a global industry leader in medical device design and
manufacturing. The company recently set up a new manufacturing facility in Johor, Malaysia
to serve current and future customers in the region as well as develop new opportuni es.
Owen Mumford develop pioneering medical products under its own brand as well as custom
device solu ons for the world’s leading pharmaceu cal and diagnos c companies.

Plas k STC Sdn. Bhd.
Established in 1988, Plas k STC is part of Kumpulan H & L High-Tech located in Selangor. The
company specialises in plas c injec on moulding services, plas c injec on mould fabrica on
and precision engineering machining parts. It has a Clean Room of class 8 for plas c moulding
medical parts. Plas k is UL approved and is a member of UN Global Compact.


AMMI Annual Report 2016 7

FULL MEMBERS DETAILS TECHNOLOGY APPLIED

3M Malaysia Sdn. Bhd. Ÿ Sterilisa on
Level 8, Block F, Oasis Square, No.2, Jalan PJU1A/7A, Technology
1.
Ara Damansara, 47301 Petaling Jaya, Selangor, Malaysia. Ÿ Others
Tel : 603-7884 2888 Fax : 603-7884 2902

Ain Medicare Sdn. Bhd. Ÿ Others
Jalan 6/44, Kawasan Perindustrian Pengkalan Chepa 2,
2.
Kota Bharu 16100, Kelantan, Malaysia.
Tel : 609-7743 388 Fax : 609-7742 205

Allen Healthcare Products (M) Sdn. Bhd. Ÿ In-Vitro Diagnos c
17, Lorong Nagasari 2, Taman Nagasari, Technology
3.
13600, Perai, Penang, Malaysia. Ÿ Plas c Technology
Tel: 604-3901168 Fax: 604-3995770
Ambu Sdn. Bhd . Ÿ Electro-Mechanical
Lot 69B , Lintang Bayan Lepas 6, Phase IV,
4. Medical Technology
11900 Penang, Malaysia. Ÿ Others
Tel: 604-252 9000 Fax: 604-644 8932

Ansell Global Trading Center (Malaysia) Sdn. Bhd. Ÿ Latex and Dipping
Prima 6, Prima Avenue, Block 3512, Technology
5.
Jalan Teknokrat 6, 63000 Cyberjaya, Malaysia. Ÿ Sterilisa on
Tel : 603-8310 6688 Fax: 603-8318 6699 Technology

APS Medical Sdn. Bhd. Ÿ Plas c Technology
No. 28-32, Jalan Teluk Batu 36/2, Ÿ Packaging
6. Batu 4 ½ , Jalan Kebun, Seksyen 36, Technology
40470 Shah Alam, Selangor, Malaysia. Ÿ Sterilisa on
Tel: 603-5162 2618 Fax: 603-5162 2619 Technology
Bard Sdn. Bhd. Ÿ Latex and Dipping
Lot 57C, Lorong Perusahaan 5, Kulim Industrial Estate, Technology
7.
09000 Kulim, Kedah, Malaysia.
Tel: 604 – 4801300 Fax: 604 – 4891737
B Braun Medical Industries Sdn. Bhd. Ÿ Plas c Technology
Bayan Lepas Free Industrial Zone,
8. Ÿ Metal Technology
P O Box 880, 10810 Penang, Malaysia.
Tel: 604-632 3100 Fax: 604-643 3750

Bemis Asia Pacific Sdn. Bhd. Ÿ Packaging
Lot 823, Jalan Subang 5, Taman Perindustrian Subang USJ 1, Technology
9.
47600 Subang Jaya, Selangor, Malaysia.
Phone: 603- 8021 0998 Fax: 603- 8021 0000
Cardinal Health (M) 211 Sdn. Bhd. Ÿ Latex and Dipping
Plot 74 A, Bayan Lepas Industrial Zone, Phase IV, Technology
10.
Mk 12, Lintang Bayan Lepas 3, 11900 Bayan Lepas, Ÿ Packaging
Penang, Malaysia. Tel: 604-252 5200 Fax: 604-644 2311 Technology

Diptech Industries Sdn. Bhd. Ÿ Latex and Dipping
No.11 Jalan Angsana 1/3, Taman Perindustrian Angsana, Technology
11.
08000 Sungai Petani, Kedah, Malaysia.
Tel: 604 -422 3688 Fax: 604 -424 0941

Dispo-Med (Malaysia) Sdn. Bhd. Ÿ Plas c Technology
21, Jalan Teknologi 3/5A, Pusat Teknologi Sinar Damansara,
12.
Kota Damansara, 47810 Petaling Jaya, Selangor, Malaysia.
Tel: 603-6730 4966/5466 Fax: 603-6143 6866


8 AMMI Annual Report 2016

FULL MEMBERS DETAILS TECHNOLOGY APPLIED

DuPont Malaysia Sdn. Bhd. Ÿ Packaging
Level 7, Menara CIMB, Jalan Stesen Sentral 2 Technology
13.
Kuala Lumpur Sentral, 50490 Kuala Lumpur, Malaysia.
Tel: 603- 285 90700 Fax: 603-285 99079
Epsilon Medical Devices Sdn. Bhd. Ÿ Plas c Technology
Lot 5271, Jalan Perusahaan 3, Kamun ng Industrial Area • Others
14. 34600 Kamun ng, Perak, Malaysia.
Tel : 605-8913158 Fax : 605-8911266

Fresenius Medical Care Produc on Sdn. Bhd. Ÿ Others
Lot 34618 PT29466, Bandar Enstek, Mukim Labu
15.
71760 Bandar Enstek, Negeri Sembilan, Malaysia.
Tel : 606-791 5334 Fax: 606-791 5336

GMMI Sdn. Bhd. Ÿ Plas c Technology
No. 12, Persiaran Industri Rapat 2, Ÿ Packaging
16. Technology
Kawasan Perindustrian Ringan Sri Rapat, 31350 Ipoh,
Perak, Malaysia. Tel : 605- 3131 912 Fax : 605- 3131 913 Ÿ In Vitro Diagnos c
Technology
Haemone cs Malaysia Sdn. Bhd. Ÿ Plas c Technology
PMT 727, Persiaran Cassia Selatan 1, Taman Perindustrian Ÿ In Vitro Diagnos c
17.
Batu Kawan, 14100 Simpang Ampat, Seberang Perai Selatan, Technology
Penang, Malaysia. Tel : 604- 503 5141

Hospitech Manufacturing Services Sdn. Bhd. Ÿ Sterilisa on
Sub Lot, 1 Lot 6536, Batu 6, Jalan Bukit Kemuning, Technology
18.
40460 Shah Alam, Selangor, Malaysia
Tel: 603-5122 5199 Fax: 603-5122 5204

Ideal Healthcare Sdn. Bhd. Ÿ Plas c Technology
No. 70 & 71, Jalan Sungai Tukang 2/1, Kawasan Perusahaan Services
19. Ÿ
Sungai Tukang, Sungai Petani, 08000 Kedah, Malaysia.
Tel : 604 -422 7775 / 8775 Fax : 604- 422 6775

ITL Asia Pacific Sdn. Bhd. Ÿ Plas c Technology
Plot 17B, Lorong Bemban 2,
20. Ÿ Metal Technology
Bemban Industrial Estate, 31000, Batu Gajah Perak, Ÿ Others
Malaysia. Tel: 605-362 9988 Fax: 605-362 9966

Johnson & Johnson Sdn. Bhd. Ÿ In Vitro Diagnos c
Technology
Level 8, The Pinnacle, Persiaran Lagoon, Bandar Sunway,
21. Ÿ Sterilisa on
46150, Petaling Jaya, Selangor, Malaysia
Technology
Tel: 603-7661 4615 Fax: 603-7610 0519
Ÿ Others
KLS Mar n Malaysia Sdn. Bhd. Ÿ Metal Technology
Lorong IKS Juru 5, Taman Industri Ringan Juru, Ÿ Electro-Mechanical
22.
14100 Simpang Ampat, Penang, Malaysia. Medical Technology
Tel: 604 505 7838 Fax: 604 504 0654

Lake Region Medical Sdn. Bhd. Ÿ Metal Technology
No. 91-B, Lebuhraya Kampung Jawa,
23. Ÿ Electro-Mechanical
11900 Bayan Lepas, Penang, Malaysia. Medical Technology
Tel: 604-810 1800 Fax: 604-643 1232
Ÿ Others
Medipro Malaysia Sdn. Bhd. Ÿ Others
Lot 15, Lebuh Hisamuddin 3, Kaw. 20, Bandar Sultan
24.
Sulaiman, 42000 Port Klang, Selangor, Malaysia.
Tel: 603-3176 3446 Fax: 603-3176 4229


AMMI Annual Report 2016 9

FULL MEMBERS DETAILS TECHNOLOGY APPLIED

Mediquip Sdn. Bhd. Ÿ Latex and Dipping
Padang La , Mukim Paya, P.O. Box 25, Technology
25.
01700 Kangar, Perlis, Malaysia.
Tel: 604- 938 1411 ext: 222 Fax: 604-938 2150

Meditop Corpora on (M) Sdn. Bhd. Ÿ Plas c Technology
Lot 3, Persiaran Usahawan, Taman iks, Seksyen 9, Ÿ Electro-Mechanical
26. Medical Technology
43650 Bandar Baru Bangi, Selangor, Malaysia.
Tel: 603-8925 8462 Fax: 603-8925 8468 Ÿ Sterilisa on
Technology
MinTec-Sinagama, Malaysian Nuclear Agency Ÿ Sterilisa on
Block 41, Malaysian Nuclear Agency,
27. Technology
Bangi, 43000 Kajang,Selangor, Malaysia.
Tel: 603-8925 0510 Fax: 603-8920 1099
Molnlycke Health Care Sdn. Bhd. Ÿ Latex and Dipping
(formerly known as Regent Hospital Products Sdn. Bhd.)
28. Lot 9 Lorong Perusahaan 4, Kulim Industrial Estate, Technology
09000 Kulim, Kedah, Malaysia.
Tel : 604- 489 1819 Fax : 604-489 1220

Nitritex (M) Sdn. Bhd. Ÿ Others
2 Jalan Jurunilai U1/20, Seksyen U1, Hicom Glenmarie
29.
Industrial Park, 40150 Shah Alam, Selangor, Malaysia.
Tel: 603-5569 3857/ 3859 Fax: 603- 5569 3862

Paramit Malaysia Sdn. Bhd. Ÿ Electro -Mechanical
Plot 372, Penang Science Park, Lorong Perindustrian Bukit Medical Technology
30. Minyak 21, Taman Perindustrian Bukit Minyak , Ÿ Others
14100 Simpang Ampat, Seberang Perai Tengah, Penang,
Malaysia. Tel : 604-6191000 Fax : 604-6191111
Prent Malaysia Sdn. Bhd. Ÿ Plas c Technology
PTD102587, Jalan Cyber 14, Senai Ind Park IV,
31. Ÿ Packaging
81400 Senai, Johor, Malaysia. Technology
Tel: 607- 599 7661 Fax: 607-599 7660

Sanmina-SCI Systems (Malaysia) Sdn. Bhd. Ÿ Electro-Mechanical
Plot 202, Lorong Perusahaan Maju 9,
32. Medical Technology
Bukit Tengah Industrial Estate, 13600 Perai, Penang Ÿ Services
Tel: 604-5081228 Fax: 604-5081233

Sin Yong Guan Industries Sdn. Bhd. Ÿ Plas c Technology
8 Solok Rishah 2, Kawasan Perindustrian Silibin
33. 30100 Ipoh, Perak, Malaysia.
Tel: 605-526 7231 Fax: 605-526 8491

Star Medik Sdn. Bhd. Ÿ Electro-Mechanical
E081 Jalan 6, Cosmoplexs, Bandar Baru Salak Tinggi,
34. Medical Technology
43900 Sepang, Selangor, Malaysia. Ÿ Others
Tel: 603-8706 5282/2934 Fax: 603-8706 5805
Stereo Sdn. Bhd. Ÿ Sterilisa on
37, Lorong Sungai Puloh 1A/KU6, Taman Teknologi Gemilang, Technology
35.
Kawasan Perindustrian Sungai Puloh, 41050 Klang Selangor,
Malaysia. Tel : 603-3290 2263 Fax : 603-3290 2016

SteriPack Asia Pacific Sdn. Bhd. Ÿ Others
PT119992, Jalan Canang Emas 8 , Telok Gong,
36.
42000 Klang, Selangor, Malaysia.
Tel : 603-3167 3596 Fax: 603-3167 3597


10 AMMI Annual Report 2016

FULL MEMBERS DETAILS TECHNOLOGY APPLIED

Straits Orthopaedics (Mfg) Sdn. Bhd . Ÿ Metal Technology
2 Lengkok Teluk Kumbar 1, Jalan Teluk Kumbar,
37.
11920 Bayan Lepas, Penang, Malaysia
Tel: 604-6494933 Fax: 604- 6494900
St. Jude Medical Opera ons (Malaysia) Sdn. Bhd.
St. Jude Medical is now Abbo Ÿ Electro-Mechanical
38. Plot 102, Lebuhraya Kampung Jawa, Bayan Lepas Medical Technology
Industrial Zone, 11900 Penang, Malaysia
Tel: 604-810 1000 Fax: 604-810 1001
Symmetry Medical Malaysia Sdn. Bhd. Ÿ Others
Plot 80C, Kawasan Perusahaan Bayan Lepas,
39.
11900 Bayan Lepas, Penang, Malaysia
Tel : 604-645 6802 Fax : 604-6445805
Synergy Sterilisa on (M) Sdn. Bhd (now part of STERIS). Ÿ Sterilisa on
40. Plot 203 Kuala Ke l Industrial Estate, Technology
09300 Kuala Ke l, Kedah, Malaysia
Tel: 604-415 2111 Fax: 604-415 2121

Teleflex Medical Sdn. Bhd. Ÿ Latex and Dipping
Lot No PT2577, Jalan Perusahaan 4, Technology
41.
34600 Kamun ng, Perak, Malaysia Ÿ Plas c Technology
Tel : 605-891 5111 Fax : 605-891 2699

Texchem Life Sciences Sdn. Bhd . Ÿ Plas c Technology
Lot 3, Jalan P/6, Kawasan Perindustrian Bangi, Ÿ Others
42. No. 2, Bandar Baru Bangi, 43650, Selangor, Malaysia
Tel : 603-8925 0370 Fax : 603-8925 0317

Top Glove Sdn. Bhd . Ÿ Latex and Dipping
Lot 4968, Bt 6 Jalan Teratai,Off Jalan Meru Technology
43.
41050 Klang, Selangor, Malaysia
Tel: 603-3392 1992/1905 Fax: 603-3392 1291/8410

Unomedical Sdn. Bhd. Ÿ Plas c Technology
Bakar Arang Industrial Estate,
44.
08000 Sungai Petani, Kedah, Malaysia
Tel: 604-4212881 Fax: 604-4215920

UWC Healthcare Mfg (M) Sdn. Bhd. Ÿ Metal Technology
987, Jalan Perindustrian Bukit Minyak, Mukim 13, Ÿ Plas c Technology
45. Kawasan Perindustrian Bukit Minyak, Ÿ Furniture/ Hospital
14000 Bukit Mertajam, Penang , Malaysia Hardware Technology
Tel: 604-5078086 Fax: 604-5079298
Ÿ Others
Vigilenz Medical Devices Sdn. Bhd. Ÿ Others
No. 308 b, Jalan Perindustrian Bukit Minyak 18,
46.
Penang Science Park, 14100 Penang, Malaysia
Tel: 604-5023 501/2 Fax: 604-5023 503
Worldwide Medivest Sdn. Bhd. Ÿ Others
No. 2, Jalan Karyawan 4/KU7, Lorong Sg Puloh,
47.
Taman Kapar Bestari, Kapar 42200, Selangor, Malaysia
Tel: 603 – 3291 2625 Fax: 603 – 3291 2725

Zeito Plas cs Components Sdn. Bhd. Ÿ Plas c Technology
Lot 19-6,Bersatu Industrial Complex, Jalan CJ1/1,
48.
Cheras Jaya, 43200 Cheras, Selangor, Malaysia
Tel : 603-9074 9177 Fax : 603-9074 9096


AMMI Annual Report 2016 11

ASSOCIATE MEMBERS DETAILS TECHNOLOGY APPLIED
Becton Dickinson Sdn. Bhd. Ÿ Metal Technology
Unit 24, LG 5 (Execu ve Wing), Hotel Equatorial Penang, Ÿ Others
1.
1 Jalan Bukit Jambul, 11900 Bayan Lepas, Penang, Malaysia.
Tel: 604 640 5688 Fax: 604 640 5686
BillerudKorsnäs AB Ÿ Packaging
C/O: Lot D12-11, Mu ara Oriental Condo, Jalan BM 1/8,
2. Technology
Taman Bukit Mayang Emas, 47301 Petaling Jaya, Malaysia.
Tel : 603 7806 1219 Fax : 603 7806 1219
Boston Scien fic Medical Device (Malaysia) Sdn. Bhd. Ÿ Others
Penang SME Centre, Plot 105 Hilir Sungai Kluang 5,
3.
Bayan Lepas Industrial Park, 11900 Bayan Lepas, Penang,
Malaysia. Tel: 604-6133421 Fax: 604-6133401
Cochlear Malaysia Sdn. Bhd. Ÿ Electro-Mechanical
Unit UG1, Upper Ground Floor, Ver cal Podium, Avenue 3, Ÿ Medical Technology
Packaging Technology
4.
Bangsar South, No.8 Jalan Kerinchi, 59200 Kuala Lumpur, Ÿ Plas c Technology
Malaysia. Tel : 603 -22823839 Fax : 603-22823839 Ÿ Sterilisa on Technology
Ÿ Services
Engineered Medical Systems Malaysia Sdn. Bhd. Ÿ Plas c Technology
1114 Jalan Perindustrian Bukit Minyak 18,
5.
Penang Science Park, 14100 Simpang Ampat, Penang, Malaysia.
Tel: 604 504 1252 Fax: 604 504 1253
MIRA Medsource (Malaysia) Sdn. Bhd. Ÿ Services
st
35, 1 Floor, Jalan Todak 6, Pusat Bandar Sunway Perdana,
6.
13700 Seberang Jaya, Penang, Malaysia.
Tel: 604-383 8025 Hp: 6012-428 2311 Fax: 604-383 1845
Orthomedic Innova ons Sdn. Bhd. Ÿ Others
188-D, Jalan Sultan Azlan Shah Sungai Tiram,
7.
11900 Bayan Lepas, Penang, Malaysia.
Tel: 604-644 5139 Fax: 604-6449139
Owen Mumford Sdn. Bhd. Ÿ Packaging
No. 21, Jalan Bioteknologi 3, Kawasan Perindustrian SiLC Technology
8.
Nusajaya, 79200 Johor, Malaysia. Ÿ Plas c Technology
Tel : 607 -5539617 Fax : 607-5539617 Ÿ Others
Plas c STC Sdn. Bhd. Ÿ Plas c Technology
No 7 Jalan TSB 9, Taman Industri Sg Buloh Ÿ Others
9.
47000 Sungai Buloh, Selangor, Malaysia.
Tel: 603-61575313 Fax: 603-61575318
Professional Tools & Dies Sdn. Bhd. Ÿ Plas c Technology
7118,Jalan Mak Mandin, Kawasan Perindustrian Ÿ Metal Technology
10.
Mak Mandin, 13400 Bu erworth, Penang, Malaysia.
Tel: 604-332 2335 Fax: 604-331 2337
Sontara South Asia Sdn. Bhd. Ÿ Others
Level 15-1, 1 First Avenue, 2A, Dataran Bandar Utama
11.
Damansara, 47800 Petaling Jaya, Selangor, Malaysia.
Tel: 603-7651 7396 Fax: 603-7651 7701
Tako Asta c Technology Sdn. Bhd. Ÿ Packaging Technology
15 Jalan Kesuma 2/2, Bandar Tasik Kesuma, Beranang,
12. Ÿ Plas c Technology
43700 Selangor, Malaysia. Ÿ Services
Tel : 603-87238843 Fax: 603-87238844
Terumo Malaysia Sdn. Bhd. Ÿ Others
Suite C405, 4th Floor, Center Tower, Wisma Consplant 1, Ÿ Services
13.
No. 2, Jalan SS16/4, 47500 Subang Jaya, Selangor, Malaysia.
Tel: 603-5880 8898 Fax: 603-5880 8891
Varian Medical Systems (M) Sdn. Bhd. Ÿ Metal Technology
Suit B-15-5, Wisma Pantai, Plaza Pantai, No. 5, Jalan 4/83,
14. Ÿ Others
Off Jalan Pantai Baru, 59200 Kuala Lumpur, Malaysia.
Tel: 603-2282 9989 Fax: 603-2282 2866

12 AMMI Annual Report 2016

2-5 March: MIDA Exclusive Invita on to
“Investment and Business Opportuni es
Seminar on Medical Devices Sector” in
Seoul, Korea
Mr Jason Ng (UWC Healthcare Manufacturing
Sdn.Bhd.) and Mr Chinniah Kalimuthu (APS
Medical Sdn. Bhd.) par cipated in the ASEAN
Korea Centre (AKC) -sponsored trip.


10 March: AMMI Q1 Progress Mee ng and
Networking, Majes c Hotel Kuala Lumpur
Thirty-eight members a ended the Q1 Progress
Mee ng where they were updated on the
upcoming events for 2016 and the AMMI 2020
Strategic Roadmap. This was followed by
presenta ons on the 2016 Healthcare Industry
Outlook by Ms Rhenu Bhuller (Frost and Sullivan)
and the 2015 Investment Performance by Encik
Ahmad Khairuddin (Execu ve Director, MIDA).
AMMI Chairman, Mr Hitendra Joshi then
presented a copy of the 2015 AMMI Annual Report
to Encik Ahmad Khairuddin to signify the release of
the report. A er the mee ng, members and
guests adjourned to Smokehouse Lounge for
networking cocktails.










23 June: AMMI Extraordinary Mee ng (EGM),
27th Annual General Mee ng (AGM) and
Q2 Progress Mee ng, E&O Hotel, Penang
Thirty-three members a ended the AMMI EGM,
27th AGM and Q2 Progress Mee ng. The AGM saw
the re-elec on of Mr. Hitendra Joshi as AMMI
Chairman; Mr. Yap Kee Keong and Ms Ong Yean Ting
as AMMI Directors for the 2016-2018 term. Dato’
Dr Haminnuddin Hj Abd Hamid was also elected to
the Board of Directors during the AGM. This was
followed by the Q2 Progress Mee ng. A er the
mee ng, members listened to presenta ons on
Revised EU Regula ons by Ms Ong Yean Ting and
Na onal Healthcare Internet of Things (ioT) by Dr
Nor Azmi Alias and Dr Khoh Soo Beng from
Collabora ve Research in Engineering, Science and
Technology (CREST). Later, members and guests
adjourned for networking cocktails.



AMMI Annual Report 2016 13

8 September: AMMI Q3 Progress Mee ng
and Networking, Majes c Hotel,
Kuala Lumpur
Thirty-one members a ended the Q3 Progress
Mee ng. The session con nued with an exclusive
Dialogue Session with representa ves from the
Ministry of Health (MOH), Medical Device Authority
(MDB), Malaysian Investment Development
Authority (MIDA) and Ministry of Interna onal
Trade and Industry (MITI). Members also were
briefed on “Strategic Ini a ves under the HRDF
Pool Fund” by the Human Resource Development
(L to R) Y.Bhg. Datuk Phang Ah Tong (Deputy CEO, MIDA), Fund (HRDF) A er the mee ng, all adjourned to
Y.Bhg. Datuk Zainal Amanshah (CEO, Invest KL), Y.Bhg. Datuk N. Smokehouse Lounge for networking cocktails. It was
Rajendran (Deputy CEO, MIDA) and Mr N. Sangaran (Execu ve
Director, MIDA) with Mr Hitendra Joshi (AMMI Chairman) also a farewell cocktail for Ms Ong Yean Ting who
had stepped down from the AMMI Board. Mr
Hitendra Joshi presented Ms Ong with a token of
apprecia on for her contribu ons to AMMI as
Director as well as Leader of the Regulatory and
Technical Commi ee.
























15 December: AMMI Q4 Progress Mee ng and Networking, E&O Hotel, Penang
Twenty-seven members a ended the Q4 Progress mee ng. Members
took note of the round up of 2016 ac vi es and planned ac vi es for
2017. This was followed by presenta ons on “Industry Collabora on
with USM and Public Private Research Network (PPRN)” by Associate
Professor Dr Yeoh Fei Yee from University of Science Malaysia (USM)
and “Mee ng the Challenges of a Growing Business through
Management of Produc vity and Rewards" by Mr Michael Ng from
Korn Ferry Hay Group. This was followed by networking cocktails.














14 AMMI Annual Report 2016

Le to right : Ma n Ng, David Koay, Maxx Lee,
Christophe Marque, Dato’ Dr Haminnuddin,
Lam Chee Hong, Tengku Muzzammil and
Kiu Chee Kuen.







8 December: AMMI Annual Golf
Tournament, Sultan Abdul Aziz Shah Golf
and Country Club, Shah Alam


Sixteen players par cipated in the fun and
friendly tournament which pi ed “North vs
South”. The North Team, captained by Dato‘ Dr
Haminnuddin fought hard against the South
Team and its Captain Daniel Lim to finally win by
a few strokes. The North Team Captain took
home the grand trophy for the year – and the
South Team will be glad to challenge it for 2017!

North Team : Dato’ Dr Haminnuddin Hj. Abdul Hamid
(Ideal Healthcare Sdn. Bhd.), Mr Lam Chee Hong, Mr
David Koay, Mr Kiu Chee Kuen and Tengku Muzzammil
(B.Braun Medical Industries Sdn. Bhd.), Mr Maxx Lee
(Professional Tools & Dies Sdn. Bhd.) and Mr Ma n Ng
(UWC Healthcare Manufacturing Sdn. Bhd. ).

South Team : Captain, Mr Daniel Lim (Sontara South
Asia Sdn. Bhd.), Mr B.L Lim (Bemis Asia Pacific Sdn.
Bhd.), Mr Andy Lee (Johnson & Johnson Sdn. Bhd.), Mr
Ian Husband, Mr Ian Cheshire and Mr Zainol Razak
(Owen Mumford Sdn. Bhd.), Mr John Ward (SteriPack
Asia Pacific Sdn. Bhd.), Mr Christophe Marque (Stereo
Sdn. Bhd. ) and Mr K.K.Tiu (Zeito Plas cs Sdn. Bhd.).

A special note of thanks to Stereo Sdn Bhd for
sponsoring the beau ful trophies.
















AMMI Annual Report 2016 15

From le to right : Y.Bhg. Datuk Phang Ah Tong, Mr BL Lim, Y.Bhg Dato' Wan Hashim Wan
Jusoh, Mr Christophe Marque, Mr John Ward, Y.Bhg. Datuk J.Jayasiri, Y.Bhg. Dato' Dr
Haminnuddin, Mr Hitendra Joshi, Y.Bhg. Datuk N.Rajendran, Mr Jorg Schneewind,
Y.Bhg Da n K. Talagavathi, Mr Suwit Tunlayadechanont,
Mr Chin Hock Meng






8 December: AMMI Annual Dinner at Neo Tamarind,
Kuala Lumpur


Ninety members and guests a ended the networking dinner.
Guest of Honour was Y.Bhg. Datuk J.Jayasiri, Secretary-
General of the Ministry of Interna onal Trade and Industry
(MITI). The evening started off with networking cocktails at
the courtyard. Mr Christophe Marque (AMMI Secretary)
welcomed new members - Boston Scien fic, Cochlear
Malaysia, Engineered Medical Systems and Owen Mumford -
with short and fun interview sessions. During dinner, guests
were entertained by lovely Arabesque dancers.

A special note of thanks to Bemis Asia Pacific Sdn. Bhd. and
Synergy Sterilisa on (M) Sdn. Bhd. (now part of STERIS) as event
sponsors.






































16 AMMI Annual Report 2016

COMMITTEE LEADER:
Ÿ Mr Hitendra Joshi (B. Braun Medical Industries Sdn. Bhd.)

MEMBERS:
Ÿ Mr Lim Bee Leong (Bemis Asia Pacific Sdn. Bhd.)
Ÿ Mr John Ward (SteriPack Asia Sdn. Bhd.)
Ÿ Mr Yap Kee Keong (Texchem Life Sciences Sdn. Bhd.)
Ÿ Mr Chin Hock Meng (St. Jude Medical Opera ons (M) Sdn. Bhd.)
Ÿ Dato' Dr Haminnuddin Hj. Abdul Hamid (Ideal Healthcare Sdn. Bhd.)
Ÿ Mr Jason Ng (UWC Healthcare Manufacturing Sdn. Bhd.)
Ÿ Mr Andy Lee (Johnson & Johnson Sdn. Bhd.)
Ÿ Mr Mark Rauenzahn (Lake Region Medical Sdn. Bhd.)
Ÿ Mr Steve Morgan (Nitritex (M) Sdn. Bhd.)


AMMI’S ROLE IN POLICY ADVOCACY
Ÿ Chairman,
Sub-Industry Working Group (Medical Devices), Industry Skills Commi ee,
Na onal Human Capital Development Council

Ÿ Member,
Medical Devices Investment Advisory Panel, Malaysian Investment
Development Authority (MIDA)

Ÿ Member,
Industry Standards Commi ee on Medical Devices and Facili es for Healthcare,
Malaysian Na onal Standards Commi ee, Malaysian Standards and
Accredita on Council


Ÿ Board of Trustees,
Malaysian Rubber Export Promo on Council (MREPC)


Ÿ Member,
Sectoral Training Commi ee, Human Resources Development Council (HRDF)


Ÿ Member,
High Impact Programme (HIP) 5: Medical Devices Ini a ve Steering Commi ee,
SME Corp. Malaysia

Ÿ Associate Member,
Asia Pacific Medical Technology Associa on (APACMed)


AMMI Annual Report 2016 17

MEETINGS & EVENTS 2016



24 February Mr Hitendra Joshi, AMMI Chairman and several AMMI members
met up with senior officers from MIDA. The objec ve of this
Mee ng with MIDA Regional
Establishment & Supply Chain mee ng was to follow up with interested members on the
Division, Penang Principal Hub Incen ve Scheme which MIDA presented during
the AMMI Q2 Progress Mee ng in 2015.



Mr John Ward, AMMI Vice-Chairman, a ended the mee ng. Mr Ward 9 March
suggested to explore poten al collabora on with MIDA on the training
of fresh graduates and quality assurance (QA) specialists or a achment MIDA’s Medical Device
of fresh graduates with the industry. AMMI also agreed to take up the Investment Advisory Panel
Chair for the Sub-Industry Working Group (Medical Devices) under the (MDIAP) Mee ng,
Industry Skills Commi ee. Kuala Lumpur

4 April Mr John Ward a ended the mee ng and submi ed AMMI’s

MIDA Mee ng with Collec ve Feedback for the 2017 Budget Incen ves Proposal.
Industry Associa ons, Refer to page 21 for full details.
Kuala Lumpur
22 July

Exclusive Dialogue Session with MIDA Top Management
and Launch of the AMMI Medical Device Industry
Outlook Report, Kuala Lumpur
– Refer to page 20 for full details.

2 Aug & 20 Oct AMMI became a member of the SME Corp HIP-5 Steering

Mee ng with SME Corpora on – Commi ee. The objec ve of the commi ee is to help local
home grown medical companies in various aspects, such as
Discussion on Pre-Implenta on of HIP5
cer fica on and regula on support, marke ng strategy
Catalyst Programme – Medical Devices support, interna onal partner search, technology roadmap
Ini a ves under SME Masterplan, development and industry landscaping; and supply chain
Kuala Lumpur management.


8 August
Mr Jason Ng (UWC Healthcare Manufacturing Sdn. Bhd.) a ended the
mee ng on behalf of AMMI. The objec ve of this mee ng is to discuss MOF Focus Group Mee ng :
“how to boost our export as the increase in import is faster than export”. Budget 2017 - Enhancing
Export Growth, Putrajaya



23 August Mr Ching Choon Siong (AMMI Secretariat) represented AMMI in the
mee ng. The objec ve of the mee ng is to encourage industry
Human Resource Development associa ons to join HRDF Sectoral Training Commi ee (STC) so that
Fund (HRDF) Sectorial Training industry training programmes can be funded via HRDF Pool Fund by
Commi ee (STC) Membership submi ng proposals for STC's approval. Update 31 August : AMMI
Engagement Session, joined the STC and will con nue to explore ways to help members to
Kuala Lumpur maximise their benefits from the HRDF Pool Fund.

18 AMMI Annual Report 2016

MEETINGS & EVENTS 2016


6-7 September AMMI par cipated in the 2-day exhibi on at KL Conven on
Centre. Aside from introducing AMMI to poten al members,
AMMI Par cipa on in the 8th AMMI representa ve, Mr Ching Choon Siong also spoke to
IRGCE MARGMA Exhibi on, visi ng groups of undergraduates about “Opportuni es in the
Kuala Lumpur Medical Device Industry”.
20 October
AMMI was the suppor ng associa on for the event. Mr Allen Ng, General
Manager from Haemone cs (M) Sdn. Bhd. represented AMMI by giving a Invest Penang SME Seminar -
talk on “Opportuni es in the Medical Device Industry“ during the seminar. Readiness for Medical Device
Supply Chain, Penang

8-10 November Mr Hitendra Joshi, Mr Christophe Maeque

and Mr Ching Choon Siong a ended the
2016 Asia Pacific Medtech Forum
forum in Singapore.



Dato’ Dr Haminnuddin hosted the SMRJ team from Japan at Concorde
Hotel, Shah Alam. The objec ve of the mee ng was to introduce the SMRJ
CEO Networking Project in Tokyo February 2017-annual programme 10 November
business networking within the Japanese and the four ASEAN countries -
Malaysia, Indonesia, Thailand and Vietnam. Four slots are allocated to Visit by Organiza on for
AMMI members to join this project in Japan. Seven AMMI companies Small & Medium
applied to join the project. Enterprises and Regional
Status update 20 December: Dispo-Med Sdn. Bhd., Diptech Industries Sdn. Bhd., Innova on, Japan (SMRJ)
GMMI Sdn. Bhd. and Symmetry Medical Sdn. Bhd. were selected by SMRJ to
par cipate in the project.

8 December
Mr Hitendra Joshi met up with the
Visit by delegates from Taiwan - Industrial Taiwanese delegates in Kuala Lumpur.
Development Bureau, Ministry of Economic Affairs, The purpose of their visit is to get to
Biotechnology & Pharmaceu cal Industries Promo on know more about the Medical Device
Office (MOEA) and Metal Industries Research & Industry in Malaysia.
Development Centre (MIRDC)


Mr Hitendra Joshi a ended the mee ng and highlighted the following issues :
1. Mapping of the medical device industry in Malaysia- We need to know
exactly the number of manufacturers in the country and also the products 14 December
they manufacture. This applies also to providers of services to the industry. MIDA Medical Device
The informa on should be available with the Medical Device Authority (MDA) Investment Advisory
since all manufacturers have to be registered with MDA. Panel (MDIAP) Mee ng,
2. Suppor ng local industry to par cipate fairly in MOH business. Greater
coopera on needed from MOH to support local industry especially the Kuala Lumpur
smaller companies and those with higher local content and higher value-add.

19 December

Medical Technology Associa on of Mr Hitendra Joshi a ended the mee ng, which saw discussions by
India (MTaI) Board and Fraternity captains of the industry on Medical Device Rules, GST, Customs
Mee ng, New Delhi, India Du es, Orthopaedic and Opthalmic Projects and more.



AMMI Annual Report 2016 19

MEETINGS & EVENTS 2016


22 July


AMMI-MIDA Dialogue Session and
Launch of the AMMI Medical Device
Industry Outlook Report




MIDA top management team and twenty- five AMMI
members a ended the dialogue session which was
chaired by MIDA CEO, Y.Bhg. Dato’ Azman Mahmud.


This was followed by the launch of the AMMI Medical
Device Industry Outlook Report 2016, officiated by
Y.Bhg. Datuk N. Rajendran, MIDA Deputy CEO II.
AMMI Chairman, Mr Hitendra Joshi gave a
presenta on of the report, highligh ng the increase
of members’ collec ve exports last year by 20% to
reach RM8.3 billion. He reiterated that this
represented more than 50% of Malaysia’s total
exports of medical devices of RM15.5 billion in 2015.
He then presented the AMMI Medical Device Industry
Report 2016 to Y.Bhg. Datuk N. Rajendran. The launch
was followed by a press conference and luncheon for
invited guests.




ISSUES HIGHLIGHTED BY AMMI DURING DIALOGUE SESSION


1. AMMI proposed a review of R&D incen ves to make it a rac ve for companies to
bring more R & D ac vi es to the country.

2. AMMI proposed to increase the ceiling of Automa on Capital Allowance for expenditure
to RM 10 million.


3. AMMI proposed that the off-take agreement (where Ministry of Health agrees to buy
medical devices that are manufactured in the country for the first me) must give due
regard to investments made by both local companies as well as mul -na onal companies
in the country over imported products or local products with cursory local content.


4. AMMI proposed that the MIDA Training Grant (currently applicable for ini al investment
projects by a new company and limited up to first five years of opera ons) should be
extended for new products or new technology transfers instead as this will help medical
companies to con nue to expand and transfer new technologies and products to
Malaysia.




20 AMMI Annual Report 2016

AMMI’S COLLECTIVE FEEDBACK
Subject : 2017 Budget Incen ve Proposal for MITI and MIDA
Submi ed : 4 April 2016


ISSUES AND PROPOSALS


ISSUE 1: Incen ves for in-house R & D ac vi es in Malaysia are based on an outdated paradigm.
The incen ves are limited to qualifying capital expenditure with no regard to intellectual assets.
The incen ves remain una rac ve to companies that are engaged both in R & D and manufacturing in
Malaysia.
PROPOSAL : To review R & D incen ves to make it a rac ve for companies to bring more R & D ac vi es
to the country. The incen ves should be extended to approved R & D centres and must include
manpower and IP (Intellectual Property) costs. Cost of joint research with universi es and research
centres should further be encouraged through the provision of grants.





ISSUE 2: Automa on Capital Allowance - current threshold is too low for medical device companies and
glove manufacturers.
NOTE
Category 1: For high labour intensive industries (rubber products, plas cs, wood, furniture and tex les),
an automa on capital allowance of 200% will be provided on the first RM4 million expenditure incurred
within 3 years of assessment from 2015 to 2017; and
Category 2: For other industries, automa on capital allowance of 200% will be provided on the first RM2
million expenditure incurred within 5 years of assessment from 2015 to 2020.
PROPOSAL: To increase the ceiling of capital allowance expenditure to RM 10 million






ISSUE 3: There are currently too many restric ons and condi ons a ached to the off-take agreement
where the government (Ministry of Health) agrees to buy medical devices that are manufactured in the
country for the first me – making the incen ve una rac ve.
PROPOSAL: The policy must give due regard to investments made by both local companies as well as
mul -na onal companies in the country over imported products or local products with cursory local
content.




ISSUE 4: Limita on on MIDA’s Training Grant – the grant is currently based on the ini al investment
project by a new company and limited up to first five (5) years of opera ons.
PROPOSAL : The training grant should be extended for new products or new technology transfers instead
of being constrained by total company basis. This will help medical companies to con nue to expand and
transfer new technologies and products to Malaysia.







AMMI Annual Report 2016 21

AMMI’S COLLECTIVE FEEDBACK
Subject : Bank Negara Malaysia Foreign Exchange Rulings
Compiled 26 December 2016

Issue No.1 Reten on of 25% export proceeds in Foreign Currency Account
AMMI Collec ve The new measures have made Malaysia a harder place to operate export-oriented
Feedback manufacturing business and more costly with exposure to forex risk, hedging
services and double foreign exchange costs. The medical device industry is part of
the global supply chain, hence natural hedge is the most effec ve way.

AMMI Request Ÿ We strongly request BNM considera on to exempt all AMMI member companies
from this new BNM ruling.
Ÿ Alterna vely, we would like to request reten on of up to 50% export proceeds in
FCA.
Ÿ We also would like BNM to provide re-assurance that re-conversion can be done
at the same spot rate.


Issue No. 2 Payment in Malaysian Ringgit between residents
AMMI Collec ve Currently there are local resident suppliers that our member companies deal with in
Feedback USD as their major material components are affected by movements of USD. All
these are supported with signed supply agreements which are not possible to
change immediately. Due to the vola lity of MYR versus USD, it is always at our
member companies’ disadvantage where suppliers are highly likely to factor that
into the pricing in MYR, resul ng in addi onal costs for our member companies.

AMMI Request We strongly request BNM considera on to allow all sales and payments between
companies opera ng in FTZ, FIZ, LMW and Bonded warehouses to be in foreign
currency to facilitate and support export for Malaysia.

Hedging not exceeding 6 months; Hedging without documentary evidence
Issue No. 3 limited to RM6 million per client, per bank

AMMI Collec ve Based on the analysis of our survey, majority of our member companies’ annual
Feedback export sales and annual payables are in foreign currency with amount exceeding
RM6 million. For longer term contracts, a longer hedging should be possible in
general (not as an excep on) without addi onal approval as there is risk of delay of
projects if approval is required to procced.
AMMI Request We strongly request BNM considera on to allow a longer me-frame for hedging
especially for longer term contracts without any approval.
We also request that hedging limit for companies opera ng in FTZ, FIZ and LMW to be
equal to value of annual sales without the need for further documenta on. Dynamic
hedging should be equal to annual sales.


Issue No. 4 Approval for foreign current assets (FCA) with value more than RM50 million
AMMI Collec ve For foreign currency that is available on our member companies’ FCA, addi onal
Feedback approval should not be required. This would slow down business transac ons and
would require a lot of documenta on and administra ve efforts. If foreign currency
is available in FCA, any limita on of business transac ons is not acceptable.

AMMI Request We strongly request BNM considera on to waive BNM approval requirement on this
issue.
22 AMMI Annual Report 2016

COMMITTEE LEADER:
Ÿ Ong Yean Ting (Johnson & Johnson Sdn. Bhd.) – un l September 2016
Ÿ Dato' Dr Haminnuddin Hj. Abdul Hamid (Ideal Healthcare Sdn. Bhd.) – from October 2016

MEMBERS:
Ÿ Mr Christophe Marque (Stereo Sdn. Bhd.)
Ÿ Ms Gan Poh Siew (Haemone cs Malaysia Sdn. Bhd.)
Ÿ Ms Chuah Chiew Teng (3M Malaysia Sdn. Bhd.)
Ÿ Ms Chuah Siew See (Teleflex Medical Sdn. Bhd.)
Ÿ Ms Quek Lang Fah (B.Braun Medical Industries Sdn. Bhd.)
Ÿ Mr Jason Ng (UWC Healthcare Manufacturing Sdn. Bhd.)
Ÿ Mr Muhammad Juzaili Jamil (Ideal Healthcare Sdn. Bhd.)
Ÿ Mr Alfred Ho (Texchem Life Sciences Sdn. Bhd.)
Ÿ Ms Queenie Lee Ching Hoay (KLS Mar n Sdn. Bhd.)
Ÿ Ms Grace Wong (Johnson & Johnson Sdn. Bhd.)
Ÿ Ms Chloe Tan (Medtronic-Mediquip Sdn. Bhd.)


MEETINGS AND FEEDBACK

25 May: Industry Standards Commi ee – Medical Device (ISC R) mee ng, SIRIM, Shah Alam
Ms Chuah Chiew Teng (3M Malaysia Sdn. Bhd.) represented AMMI in the mee ng.
Key takeaways from the mee ng:
1. Updates on Good Lab Prac ce (GLP) facili es in Malaysia
• Biocompa bility Lab or “Makmal Bioserasi” in UKM (for biocompa bility studies only)
- will be ready soon.
• MyBioScienceLab (MBSL) in Malacca (for full range of ISO10993 tests)
- 90% of its infrastructure is completed.
• Ins tute for Medical Research (IMR) lab is cer fied and available for toxicology tests.
2. ISC R is officially adop ng the ISO13485: 2016. Companies cer fied to the earlier versi on.
(MS ISO13485: 2006) has 3 years for transi on to the latest version, which ends March 2019.


30 May : AMMI Feedback to Medical Device Authority (MDA) on Medical Device Labelling
Implementa on
AMMI collec vely proposed a 3-year transi onal period. Among jus fica ons given were me and
capital investments required for purchase of new label prin ng equipment. Refer to full details on
page 25.



AMMI Annual Report 2016 23

MEETINGS AND FEEDBACK


13 September & 19 October : MDA Mee ng with Industry – Dra Guidance on Code of
Adver sement for Medical Device, Putrajaya
The first mee ng was a ended by Ms Chuah Chiew Teng (3M), Ms Chloe Tan (Medtronic) and
Ms Grace Wong (Johnson & Johnson). The subsequent mee ng was a ended by Ms Chloe Tan.
The following issues are pending commi ee decision
Ÿ 3.3.2 Endorsement by Health Professionals - Sugges on to exclude this clause for adver sement
to Healthcare Professionals (HCP)
Ÿ 3.3.7 Superla ves – Sugges on to exclude this clause for HCP
Ÿ 3.4.1 Claims rela ng to ageing and premature ageing and Annex B – Sugges on to exclude word
an -ageing
Ÿ 3.10.2, 3.10.3 and 3.10.5 – Sugges on to exclude these clauses for adver sement to HCP.


30 September: AMMI Nomina ons for the MDA Medical Research and Ethics Commi ee
2016-2018
AMMI nominated Dato’ Dr’ Haminnuddin (Ideal Healthcare Sdn. Bhd.) as Representa ve and
Mr Jason Ng (UWC Healthcare Manufacturing Sdn. Bhd.) as Alternate Representa ve.



13 October : MDA Mee ng with Industry : Dra Guidance: “Guideline For Registra on Of
Drug-Medical Device And Medical Device-Drug Combina on Products”, Putrajaya
Dato’ Dr Haminnuddin and Ms Grace Wong (Johnson & Johnson Sdn.Bhd.) represented AMMI in the
mee ng. Issues highlighted by the industry were transi on period / effec ve date, parallel submission
to NPRA and MDA, GDPMD/ GMP/ISO requirement, validity period for endorsement le er, process
meline review in the event the drug and device obtained approval separately, endorsement le er
by NPRA/MDA and change/ varia on issues. All are s ll pending final decision from MDA.


26 October : MDA Seminar with Medical Device Industry, Penang
Ms Gan Poh Siew (Haemone cs Malaysia Sdn. Bhd. ) and Ms Queenie Lee (KLS Mar n Sdn. Bhd.)
a ended the seminar on behalf of AMMI. Topics presented during the seminar were :
Ÿ New Policies and Guidelines to Support the Implementa on of Medical Device Act
Ÿ Registra on by way of Verifica on Process
Ÿ Medical Device Exemp on Order 2016
Ÿ Establishment Licensing
Ÿ Cer ficate of Free Sale, Export Permit, Off-take Agreement and Future Programmes for Industrial
Support
Ÿ New Requirements for Regula ng Labelling
Ÿ Post Market Surveillance & Vigilance



1 December : Industry Standards Commi ee – Medical Device (ISC R) Mee ng, SIRIM, Shah Alam
Ms Chuah Chiew Teng (3M Malaysia Sdn.Bhd.) represented AMMI in the mee ng. She reported that the
2nd Medical Device Regula on will consist of (1) Adver sement (2) Maintenance (3) Post Market
Surveillance and (4) Designated Medical Device (eg: devices used in beauty salon – laser etc.) users will also
be regulated.






24 AMMI Annual Report 2016

AMMI’S COLLECTIVE FEEDBACK

Subject : Transi onal Period for Implementa on of Medical Device Labelling
Submi ed : 30 May 2016


PROPOSED TRANSITIONAL PERIOD : 3 years
AMMI proposes a stepwise approach in enforcing the labelling requirement over a period of three (3)
years – which will be more feasible when the industry has se led down with the current registra on
exercise.


JUSTIFICATION ON PROPOSED TRANSITIONAL PERIOD


1. EQUIPMENT
Ÿ Purchase of new label prin ng equipment requires me and capital investments (sourcing,
equipment qualifica ons, so ware valida on, training).
Ÿ Re-configura on of exis ng prin ng equipment to cater for the new labelling requirements
(equipment qualifica ons, so ware valida on, training).


2. LABELLING
Ÿ Label design, review and approval of artworks and language transla on (Internal and External
Par es) requires me and resources.
Ÿ Purchase of new labels requires me and resources (artwork design/redesign, verifica on, order
lead me, inspec on etc.).
Ÿ Industry will require MDA to allow “s ckering” of labels.



3. PHASING OUT OF CURRENT STOCKS
Ÿ Clearance of exis ng label stocks – me required especially for slow moving products
Ÿ Clearance of physical stocks with exis ng labels from manufacturing plants, warehouses,
distribu on centers and distributors.
Ÿ Phased transi on from exis ng to new labels for marketed products.
Ÿ Cost factor - Inventory/stock of old artwork to be used before replenishing the new. Also, some
devices are slow-moving.


4. UPDATE OF PRODUCT REGISTRATION
Ÿ The “Registered with MDA” label can only be affixed a er obtaining registra on approval from
MDA. Registra on is by “family”, hence revision of numerous artwork will be required at any one
me. Addi onal transi on period is required upon approval, in order to revise the artwork and
labels of products.
Ÿ The industry needs MDA’s confirma on that the labelling of “Registered with MDA” is
mandatory for devices placed in the Malaysian market only (and not required for export).
Ÿ A transi on period is required before the company obtains the cer ficate from MDA. This is
important for those products which its registra on applica on has been submi ed to MDA
th
before 30 June 2016 and have the benefit of con nuous commercial ac vity in local market.
Ÿ Time and resources needed at MDA to review and approve new labels in the product
registra on dossier. In addi on, for the export market (for products with shared labels with
other countries), ample transi on me is required to revise artwork and receive approval
from other markets before new labels can be implemented.


AMMI Annual Report 2016 25

COMMITTEE LEADER:
Ÿ Mr Yap Kee Keong, Texchem Life Sciences Sdn. Bhd.


MEMBERS:
Ÿ Mr Hitendra Joshi, B. Braun Medical Industries Sdn. Bhd.
Ÿ Mr Suwit Tunlayadechanont, Synergy Sterilisa on (M) Sdn. Bhd. (now part of STERIS)
Ÿ Mr Chin Hock Meng, St. Jude Medical Opera ons (M) Sdn. Bhd.
Ÿ Dato' Dr Haminnuddin Hj. Abdul Hamid, Ideal Healthcare Sdn. Bhd.
Ÿ Mr Michel Van Crombrugge, Paramit Malaysia Sdn. Bhd.
Ÿ Ms Jess Tew, KLS Mar n Malaysia Sdn. Bhd.


ACTIVITIES AND EVENTS

Career Talk at University of Science Malaysia (USM) Penang
25 March Mr Hitendra Joshi gave a presenta on on the “Opportuni es in the
Medical Device Industry” to over 100 USM students.
AMMI Medtech Talent and Employment Programme (MTEP) Batch 2
12 April
Comple on Ceremony, Sunway Hotel, Penang
Training: ISO13485: 2016 Internal Audi ng, Majes c Hotel,
21 - 22 April
Kuala Lumpur
6 May AMMI HR Forum and Networking Mee ng, E&O Hotel, Penang

Training: Medical Device Manufacturing Process Valida on,
1 - 2 June
E&O Hotel, Penang
Training: Transi on to ISO13485: 2016 Quality Management System,
20 -21 July
E&O Hotel, Penang
Training: Risk Management for Medical Devices, G Hotel Gurney,
5 - 6 October
Penang

18 October AMMI HR Forum and Networking Mee ng, Hilton Hotel, Petaling Jaya


9 - 10 November Training: FMEA for Medical Device Manufacturing, E&O Hotel, Penang

Training: Fundamentals of Steriliza on, Concept to Market, Rou ne
29 November
Valida on and Control, Eas n Hotel, Penang





26 AMMI Annual Report 2016

12 April : AMMI-NCIA Medtech Talent and
Employment Programme Comple on Ceremony
at Sunway Hotel, Penang
The AMMI-NCIA Medtech Talent and
Employment Programme Batch 2 concluded with
the Comple on Ceremony for the graduate
trainees. Mr Michael Raja, Manager of Educa on
& Human Capital Development, of Northern
Corridor Implementa on Authority (NCIA),
together with Mr Hitendra Joshi (AMMI
Chairman) and Mr Yap Kee Keong (AMMI
Director & Leader of Talent Development
Commi ee) presented the cer ficates to the
graduate trainees. Also in a endance were Cik
Azhana Bin Mohamed Saleh (Director, MIDA
Penang), Encik Abdul Muk bin Abu Bakar
(Director, MIDA Kedah & Perlis), Puan Nor
Asmahan Othman (Industry Partnership, Talent
Corp) and representa ves from par cipa ng
companies.











Abio Orthopaedics Sdn. Bhd. Haemona cs Malaysia Sdn. Bhd.












B.Braun Industries Sdn. Bhd. UWC Healthcare Mfg Sdn. Bhd.












Synergy Health Sterilisa on Sdn. Bhd. (now part of STERIS) Penchem Medical Sdn. Bhd.













Epsilon Medical Device Sdn. Bhd. Teleflex Medical Sdn. Bhd.
AMMI Annual Report 2016 27

6 May, E&O Hotel, Penang

6 May & 18 October -
AMMI HR Forums and Networking Mee ngs

The main objec ve of the forums is to provide a networking pla orm for human resource
professionals of member companies to discuss and exchange ideas on current human
resource and talent issues. Topics presented during these forums were on Compensa on
and Benefits (by speakers from Korn Ferry Hay Group) and the Impact of TPPA on the
Labour Law (by representa ve from Ministry of Human Resources). Members also
par cipated in sharing sessions on employee mo va on and reten on.















18 October, Hotel Hilton Petaling Jaya



AMMI also introduced the
interac ve “World Café Workshop”
during the AMMI HR Forum held in
Petaling Jaya on 18 October.


Led by Ms Cynthia Ooi (Vice-President of
Human Resources, B.Braun Medical Industries),
Mr Joshua Chong (Senior Human Resource
Manager, Ambu) and Encik Ahmad Nordin
(Assistant General Manager, Texchem Group),
par cipants were divided into three groups and
worked on topics :
(1) Sharing Employee Reten on Strategies
(2) Engaging Your Employees
(3) Employee Mo va on


The workshop encouraged a lot of sharing
among par cipants and was very highly rated.





28 AMMI Annual Report 2016

AMMI organised six public training classes and trained over 180 par cipants in 2016









21-22 April: ISO13485: 2016
Internal Audi ng,
Majes c Hotel, Kuala Lumpur
No. of Par cipants: 27
No. of Companies: 14





1-2 June: Medical Device
Manufacturing Process Valida on,
E&O Hotel, Penang
No. of Par cipants: 18
No of Companies: 10




















20-21 July:
5-6 October: Transi on to ISO13485: 2016
Risk Management Quality Management System,
for Medical Devices, E&O Hotel, Penang
G Hotel Gurney, Penang No of par cipants: 40
No. of Par cipants: 27 No of companies: 18
No. of Companies: 12




9 - 10 November: FMEA in Medical
Device Manufacturing,
E&O Hotel, Penang
No. of Par cipants: 15
No. of Companies: 6



29 November: Fundamentals of
Steriliza on, Concept to Market,
Rou ne Valida on and Control,
Eas n Hotel, Penang
No. of Par cipants: 46
No. of Companies: 21


AMMI Annual Report 2016 29

1. Medical Device Exports Set to Rise, New Straits Times - 23 July 2016

2. Eksport Peralatan Perubatan Dijangka Cecah RM17 bilion, Berita Harian Online
- 22 Julai 2016 (h p://www.bharian.com.my/node/175872)
3. Export of Medical Devices Increase by 15% and is Expected to Hit RM17.8 billion,
Nanyang Siang Pau - 23 July 2016

4. Medical Device Exports to Increase to RM17.8 billion, The Borneo Post - 23 July 2016
(h p://www.theborneopost.com/2016/07/23/medical-device-exports-to-increase-
to-rm17-8-billion/)
5. Export of Medical Tools to Hit RM18b,The Malaysian Reserve -25 July 2016

6. Malaysia’s Manufacturing Medical Devices Export to Reach RM17 billion in 2016
SME Magazine, Asia - 26 July 2016 (h p://smemagazine.asia/2016/07/
malaysias-manufacturing-medical-devices-export-to-reach-rm17-billion-in-2016/)

7. Malaysia Recorded Outstanding Value Added Ra o in Manufacturing Medical
Devices, Export Growth to Reach RM17 Billion in 2016, Bernama News - 22 July 2016
(h p://www.bernama.com/bernama/v8/newsindex.php?id=1265462)





30 AMMI Annual Report 2016