SAMED in review

SAMED
In Review

2016

Index Pg 2

Message from our Chairperson and Executive Officer Pg 3

Welcome to SAMED new members for 2016: Pg 3

Committee Round-Up 2016 Pg 3
Pg 3
 SALDA / SAMED Africa Forum Pg 4
 Code of Business Practice Committee Pg 6
 Congress Committee Pg 6
 Government Procurement Committee Pg 7
 SABS / DTI / SAMED Forum Pg 7
 Health Economics and Reimbursement Committee Pg 8
 Health Market Inquiry Pg 8
 Orthopaedic Special Interest Section (OSIS) Committee Pg 11
 Regulatory Committee
 Transformation and Small Business Committee Pg 11

SAMED: Engaging in Global Markets Pg 12

Association News Pg 14

CRICE Update Pg 15

SAMED 2016 Salary Survey: Key Highlights Pg 16

SAMED Benefit Survey 2016 Pg 18

Movers and Shakers Pg 18

SAMED Events 2016

1

Jeff Hampton Tanya Vogt SAMED ethical business and marketing practices, which in
SAMED Chairperson Executive Officer turn ensures that healthcare professionals make an

informed decision based on clinical criteria as to the
best medical devices required for their patients. On
29 September 2016, SAMED decided to resign from

the Marketing Code Authority (MCA), and to fortify
and apply its dedicated Medical Device Code of

Ethical Business and Marketing Practice. To this
end, the SAMED Board has decided that its
members will proactively self-regulate and embrace

its own Medical Device Code of Ethical Business
and Marketing Practice as from January 2017. So

we ask all members to watch out for this early next
year!

Message from our Chairperson Important to note is that SAMED represents all
Medical Devices and IVD companies, be they

and Executive Officer multinational, distributors, small business or local
manufacturers. While we always try to assist

2016 has been a significant year for SAMED and individual companies if they have an issue, to this
end, we cannot favour one group over the other and
the South African Medical Device and IVD Industry. really focus our efforts on cross-cutting issues that
Noticeably the recent Medicines Control Council
requirement to licence Medical Device and IVD affect our industry as a whole.

establishments and the resurfacing of outstanding Finally a word of thanks:
payments from Provincial Departments of Health,

SAMED has continued to solidify its role as the One of our major operational costs is hosting events
Voice of the Medical Device Industry within the throughout the year. In order to keep costs down we
health sector of South Africa. often rely on members to host us. We wish to thank

This is ever more apparent with our continued the following member companies for their support in
growth in membership with a record number of 36 this regard:

new members this year! We have not only grown in  BD
membership but in offerings for our members. This  Siemens
year, SAMED held a whopping total of 31 work- 
shops, trainings, general member meetings and our  Baroque Medical
flagship Annual Conference.  3M South Africa
Medtronic

SAMED’s engine room are its Committees. We wish  CSIR
to thank the committees for their continuous hard  Suprahealthcare
work, robust debate, and the real change they are  BSN Medical
bringing about within our industry. In many ways our  Gabler Medical
members see the value of SAMED through these  Hutz Medical

Committees, so we urge all members to participate, Thanks is also extended to our board members and
get involved and be part of the change they would the very capable SAMED team their support, hard
like to see in their industry association. work and enthusiasm.

SAMED continues its unrelenting fight for Here’s to a prosperous 2017!
recognition of the uniqueness of medical devices.

Through our engagement with key stakeholders, we

are seeing a change in mind-set, and stakeholders

are now coming to us for advice. SAMED is not only

gearing up to hold procurement workshops with

Kwa-Zulu Natal and Gauteng Department of

Health’s supply chain managers, but have

established a unique Medical Device working group

with the Medicine Control Council (MCC). 2

For more than three decades, SAMED has been
committed to ensuring its members adhere to

Welcome to sharing information for importation and registration
SAMED new purposes or doing business in Africa as well as
members for sharing access to market information.
2016:
2016 has seen this Committee grow in not only
 Africoncur Medical membership but in the enabling of our members in
 Anstem Medical (Pty) Ltd these emerging markets. Whilst there is often a lack
 Ascendis Medical of clarity and consistency with the regulatory re-
 Ashanti Medical cc quirements in each African country, the Committee
 Avacare Orthopaedics (Pty) Ltd has been able to foresee changes in regulations /
 Bloemed Medical Supplies & Services cc requirements before they have been implemented,
 Corin SA (Pty) Ltd giving members up to date information as it hap-
 Creatori Health pens.
 Electronic & Medical Technologies
 Enterprise Ireland In the rapidly changing environments of these
 Future Med Co. (Pty) Ltd emerging countries including multiple pathways to
 Langamedics (Pty) Ltd entry, the Committee has developed a database of
 Lima Orthopaedics South Africa (Pty) Ltd relevant contacts throughout the continent. The
 LTE Medical Supplies (Pty) Ltd Committee reports any recent regulatory develop-
 Maquet Southern Africa ments in the various African countries through its
 Medical Distinctions
 Meril SA (Pty) Ltd minutes. All of these documents are available to
 Mira Med members on request.
 Modiro Medical (Pty) Ltd
 Ossimed (Pty) Ltd The Committee relies on members with experience
 Pharma-Med Solutions (Pty) Ltd to share information with other committee members,
 Pinnacle Innovations (Pty) Ltd as Chair, I would like to thank everyone for being
 Premier Endoscopy open, insightful and informative! We look forward to
 PRISM Inter Africa cc an exciting 2017.
 Q-Surgical (Pty) Ltd
 Respiratory Care Africa Code of Business Practice
 Redermis (Pty) Ltd Committee
 Silverleaf Healthcare (Pty) Ltd
 Wilmartan t/a Solutions Medical The SAMED Code of Business
 Surgical Innovations Practice Committee was
 Synthecon Sutures cc re-established in August with the
 The Scientific Group objective of updating the Medical
 Tumisang Wholesale & Medical Delivery Inc Device Code of Ethical Marketing
 Mawele Invest CC Trading as Twinz Regula- and Business Practice.

tory Affairs Rob Millar On 29 September 2016, SAMED
 UL VS South Africa (Pty) Ltd Code Committee decided to resign from the Market-
 V-Tech Pharma (Pty) Ltd
Chairperson ing Code Authority (MCA), and to
Committee Round-Up 2016 fortify and apply its dedicated

SALDA / SAMED Africa Forum Medical Device Code of Ethical Business and
Marketing Practice. Subsequent to SAMED’s
The Africa Committee is largely resignation from the MCA, it was necessary for the
an informative committee for the Committee to provide guidance on the way forward
SAMED members. The main to ensure that all SAMED members remain under
objectives include developing a the ambit of a Code governing the supply of Medical
database of information about Devices and Diagnostics.
African country requirements for
Avanthi Bester medical device and IVDs, 3

Africa Committee
Chairperson

The Committee is currently busy finalising the  Will there be sufficient transparency with
Medical Device Code of Ethical Business and regards to how the funds are utilised?

Marketing Practice which now incorporates

guidelines regarding the use of Private Nurse  Selection of Delegates
 Who and how are the delegates select-
Practitioners and free market value guidelines
ed?
amongst others. We are also reviewing certification

requirements. SAMED wants to improve its enforce-  What are the criteria to qualify for
ment and sanctioning capabilities. Proposed selection?

changes include plans to have an independent  Will there be selection guidelines in
investigative arm (with anonymous reporting and a place to allow for transparency?

forensic lawyer) which will be able to deal more

efficiently with transgressions of its code and ensure To date, MedTech has implemented a phased in

the Medical Devices industry is more accountable approach for national members to adhere to the

and better regulated. prohibition of direct sponsorship of HCPs to third

The Committee is exploring various channels to party congresses. As such, the Congress Commit-
promote the Medical Device Code of Ethical tee will continue to liaise with MedTech so as to
Business and Marketing Practice including meeting gain clarity and it will report back to the SAMED

with other key stakeholders such as funders, members and other interested stakeholders
hospital groups, provincial government departments accordingly.

and professional associations. From early in 2017, The Committee has also been engaging with the
we plan to launch the Medical Device Code of Congress Vetting System (CVS) of MedTech on the
Ethical Business and Marketing Practice with all key appropriateness of certain South African venues

stakeholders, both public and private and roll out such as Sun City due to its resort component. The

free workshops and training sessions to assist Committee is in the process of analysing a schedule

member companies with compliance.

of venues to propose to CVS to consider deeming

Congress Committee appropriate. The SAMED Congress Committee is,
on the whole, satisfied with the progress made this
The Congress Committee had an year, and as always, we look forward to a
eventful 2016, holding two major productive 2017.
workshops and interacting with

international organisations Some photos from the MedTech workshop held with
regarding MedTech decision to members in April 2016:

disallow the direct sponsorship of

Healthcare Professionals (HCP’s)

Albert Denoon to third party organised congresses.
A key objective being to gain further
Congress feedback and insight into how this
Committee
Chairperson ruling would be accepted in the
South African environment and the

suitability of congress venues themselves.

The first workshop, held in April, was with CEO’s
and major decision makers from the SAMED
membership. The second workshop, held in June,
was with Doctor Associations and Societies. It
became apparent from those workshops, that
acceptance of the ruling and buy-in from all
stakeholders is mixed.

A number of questions require address and clarity if
indirect sponsorship is implemented:

 Management of Funds 4
 How will the funds be managed /

utilised?
 Who will manage – sufficient business

acumen?



Government Procurement member survey this year, which indicated that
Committee R830million is outstanding to our members across
all Provinces. SAMED has written to the Ministers of
The overarching objectives that Health and Finance requesting a meeting to discuss
our Committee focuses on, albeit the dire ramifications this has for the sustainability of
in different forms, are: our sector.

 Issue of non-payment for our However in the interim the Committee has met with
members by Provincial
the task team on non-payment of suppliers’ invoices
Departments of Health
Marlon Burgess within the Department of Monitoring and Evaluation
Government Procurement of Medical
 that sits within the Presidency. The following was
Procurement
Devices and IVDs in both the agreed:
Committee private and public sector
Chairperson

2016 was an impactful year for our Committee.  An urgent meeting between SAMED and the
errant departments will be convened before

We had a crucial role in the development of the the end of November. It was further agreed
theme of this year’s SAMED Annual Conference that the Chief Procurement Officer (CPO)
with the first day being solely dedicated to best would be present in these engagements. This
meeting should culminate in clear, binding
practices in procurement of Medical Devices. The agreement on how departments are going to
Committee invited a number of government supply

chain and procurement managers to attend this day settle outstanding legitimate invoices;
for free. This resulted in the highest number of pub-  A copy of the minutes of the meeting will be
lic officials attending the conference to date. sent to the Deputy Minister in the Presidency

External and international speakers at the Another challenge we are starting to notice is that a
number of Provinces are implementing the new
conference assisted us in breaking down a number Draft Preferential Procurement Regulations 2016;
of barriers between public sector and industry as
well as building a good platform for a successful however this legislation has not yet been passed by
Parliament. The Committee is concerned that this
relationship with a number of public sector officials.
Subsequently after the conference two provinces,
Kwa-Zulu Natal (KZN) and Gauteng have requested process may hold a number of consequences for
industry. The Committee drafted a comprehensive
procurement workshops for their supply chain submission on these draft regulations and will
managers, which will be hosted by SAMED. continue to engage with relevant stakeholders on

In 2015, the Committee assisted the Gauteng this issue.

Department of Health with its e-invoicing project. SABS / DTI / SAMED Forum
We supported the department in mainstreaming

their invoicing processing to a digital format. In This year saw the establishment of a DTI led Forum
2016, we held a member workshop to re-educate consisting of DTI, National Department of Health,
our members on this system as well as the
consignment stock process that has been National Treasury, SABS, SAMED and MDMSA.
implemented at both the Charlotte The SAMED Board recognised the importance of
Maxeke Johannesburg Academic Hospital and the such a Forum and developed a technical working
Chris Hani Baragwanath.
Committee to engage with this Forum from an in-
dustry perspective. The Forum meets on a quarterly

This year, we engaged with a number of key basis to iron out any challenges each stakeholder is
stakeholders including being invited to a meeting by facing, strengthening partnerships in the process.

the MEC of Gauteng Health with all the financial At a meeting in October, it was agreed that the
officers of all the public hospitals in Gauteng. This National Treasury will meet with industry and review
meeting was to assist these hospitals in what is
gaps in the Medical Device value chain for SA and
needed to track all assets and develop an asset arrive at a way forward. In 2017, we will continue to
registry within their hospitals. This led to an
ensure that our member’s procurement and
informative and engaging discussion on best payment challenges are resolved as we work
practices in procurement of Medical Devices. towards a sustainable solution.

A major focus this year was the issue of outstanding 6

payments to our members by Provincial

Departments of Health. The Committee conducted a

Health Economics and of healthcare professional services and
Reimbursement Committee goods”, tenders which were issued to private
hospital groups. We subsequently wrote to

The Health Economics and both the Health Professional Council of South
Reimbursement (HE & R) clarity on how medical schemes should

Committee had a number of embark on tender processes as well as
strategic objectives for 2016, which whether if healthcare professionals should be

saw our three sub groups, working are allowed to participate in this practice if it
on numerous projects throughout contravenes their ethical codes of practice.

Tanya Watson the year. We encourage all SAMED Members to consider

Health Economics The Heath Technology attending Post Basic Course in Health Technology
and Assessment run by the University of Stellenbosch.
Reimbursement Assessment (HTA) and HE work
Committee group executed a number of Contact Nazreen Abrahams on 021 938 9201 if you
are interested in attending this course.
successful HTA sessions at the

SAMED Annual Conference focusing on internation- As the chair of this Committee I would like to thank
al best practices and local centres of excellence of everyone for their support and Guidance this year!
reimbursement of Medical Devices, as well as what

is practically needed to make HTA in South Africa a Health Market Inquiry
reality.

The Committee ran two highly effective workshops The Competition Commission's Health Market In-
this year. The first, had Netcare, Discovery inform quiry is currently investigating the high cost of pri-
the members on how to get new technology into
hospital groups and covered by private funders and vate healthcare in South Africa and has reason to
consultant Hasina Cassim provided tips and advice. believe that features of the sector prevent, distort or
The second, held in November looked specifically at restrict competition. SAMED recognises that this
“Medical Devices: Market Access & Procurement - Inquiry may have impeding implications for the Med-
Past, Present & Future” drawing on experiences ical Device Industry. In response to this Inquiry and
from international experts such as Yves Verboven, in line with our 4 year strategy, SAMED has put to-
Director Market Access and Economic Policies for gether a key ad hoc Committee with expert legal
MedTech Europe as well as local reimbursement input, dealing with all developments including the
experts such as Professor Manie de Klerk, Head: provision of oral presentations and submissions to
Clinical Policies at MMI Health. The workshop also the Inquiry in response to allegations that Medical
Devices are a cost driver in the high cost of private
highlighted through Natalie Zimmelman, Chief healthcare in the country. Please click here to view
Executive Officer, SASA, how companies should all our submissions.

engage with users of their Medical Devices and how In SAMED’s last submission dated 24th of October
to prevent conflicts of interests and perversity. 2016 SAMED highlighted the following:

Some of main activities of the year included:  SAMED’s view is that doctor’s trading in
medical devices, which they use on their
 The Committee requested that Discovery patients does lead to potential conflicts of
Health Surgical Risk Management and Clinical interest, contravenes Ethical Rule 23(1) of the
Policy Unit hold an update meeting on their 2006 Ethical Rules of the HPCSA and
new PIN process and expectations. This therefore should be prohibited.
workshop had over 80 attendees A number of allegations were made in these
hearings that rebates on Medical Devices are
 The University of Pretoria along with consult-  still occurring. SAMED stated that with the
ant Debjani Mueller have developed a pilot envisaged implementation of section 18A as
HTA course for 12 fellows. The Committee amended, of the Medicines Act (see Acts 72
provided input into this pilot course and will be of 2008 and Act 14 of 2015), and
engaging with the University in the upcoming accompanying regulations, the issue of
year, when the University looks to roll out the rebates and perversities could be addressed
course to the public. where and to the extent that it might still exist.

 Committee members attended a meeting at 7
Netcare to understand how their newly
automated system, the GS1 Bar Coding will
impact industry going forward.

 The Committee became aware that medical
schemes have issued tenders for “the supply

 In the last set of hearings, a number of The DTC advised all stakeholders that the updated

hospital groups benchmarked higher prices of NHI White Paper with a funding model will be

medical devices in South Africa than in other released in 2016. The Committee will keep you

countries. SAMED noted that all types of posted on this development!

products exhibit a range of price variation,

both within and between countries. These are Orthopaedic Special Interest

done in response to competitive forces and Section (OSIS) Committee

country-specific features, such as the

structure of the health sector. OSIS is specifically involved in

 SAMED noted that it was stated in the Elective Orthopaedics, Trauma and

hearings that the reuse of single use devices Spine, working closely with the

is prevalent in India and should be considered South African Orthopaedic

in South Africa. There are currently no Association (SAOA). The Commit-

procedures or guidelines to re-sterilise tee was revived by the request from

Medical Devices in South Africa, SAMED Tony Lowther OSIS the SAOA who asked for guidance
therefore supports the position of Committee
manufacturers that devices marked as on certain issues relating directly to

Chairperson their Association. The Committee

single-use (i.e. regulated and registered for has engaged with the Association

that purpose only, and also as is required by around fair market value guidelines, venue vetting,

the Consumer Protection Act) may not be re and sponsorship to and for congresses as well as

processed or re-used, in the interest of patient fellowships. The Committee successfully presented

safety and infection control. on all these issues to the SAOA in April 2016. The

 and purchasing policies and practices. Committee has provided the SAOA with an example

template of a contract between a company and an

National Health Insurance HCP as a guideline for fair market value consultan-

cy arrangements.

SAMED recognises the importance of NHI in the

near future to both our industry and the country. The Committee also engaged with the South African

SAMED established an ad hoc committee that National Joint Registry (SANJR), to explore the

reviewed the NHI white paper that was released 10 purpose of the registry and how to partner with the

December 2015. SAMED has drafted a written registry to ensure better data collection and

submission commenting on the NHI white paper, outcomes. Feedback is expected from the SANJR.

focusing on the importance of innovative medical

technologies, best practice procurement models for The committee is looking to renew its focus and

Medical Devices and the extensive human resource drive in 2017.

requirements needed to build a solid foundation for

the system. Regulatory Committee

In early 2016, the committee hosted a very The SAMED Regulatory Commit-
successful workshop with key experts including Dr
Mark Blecher, Chief Director for Health and Social tee consists of >30 members from
Development, National Treasury who briefed our
audience on the NHI from National Treasury's a diversity of companies within the
perspective and the possible funding models.
Medical Device industry, including
On the 1st of September 2016, the Davis Tax
Committee (DTC) invited both written submissions multi-nationals, local manufactur-
on the funding of the NHI as proposed in Chapter 7
of the White Paper on the NHI White Paper entitled ers, distributors and consultants. A
Health Insurance for South Africa: Towards
Universal Coverage, followed by oral submissions in core working group of 18 meet
support of the written submissions.
every month to progress the

Madeleine Pearce strategic objectives of the Commit-
Regulatory
Committee tee.

Chairperson

Objectives that were prioritised for

2016 were:

The Committee provided both a written and oral 8
submission highlighting a number of key issues
including the Medical Device’s largely unregulated

market and the budgeting for devices in NHI that
should consider cost to render quality care in a
regulated environment.

 To proactively influence and drive for locally to the ISO13485 standard for Quality
appropriate regulations by engaging with Management Systems for medical devices. SAMED
stakeholders and consumers of our products
will participate in the SANAS working group for
 To provide SAMED members/stakeholders ISO13485.The Committee has approached the
with direct knowledge of industry and Regulator to resolve the way forward for combina-
international trends and developments
tion medical devices which are currently registered
2016 has been a pivotal year for the SAMED as medicines. The Registrar responded indicating
Regulatory Committee. This year, the South African
National Department of Health’s mandate given to that companies with products registered on the
the Medicines Control Council (MCC) to regulate medicines register are encouraged to retain the
Medical Devices, resulted in an instruction to Medi- registration (s) until such time as the Regulatory is
cal Device companies to start the process of listing
their activities and products in a licensing initiative in a position to commence with registration of
that commenced on 1 August 2016 and is due by Medical Devices. This response was circulated to
the 31 January 2017.
members. In some cases, these products will need
to be transferred from the medicines register to the

Medical Devices register and should be subject to
device regulation.

In response to this instruction, and in partnership On the international front, the SAMED Regulatory

with associate member SALDA (the Southern Africa Committee continues to be involved at a variety of

Laboratory Diagnostics Industry Association), the forums that promote internationally harmonised

Committee embarked on a series of monthly medical device regulation. Harmonisation ensures

Regulatory Forums, where SAMED members could that best practice for safety and quality is

learn about the imminent regulation of our industry: implemented in South Africa, while avoiding ‘special’

requirements demanded of the industry by the

Topics covered so far have been: Regulator, which could add unnecessary cost and

 The Quality Management System for Medical regulatory burden to companies that provide much

Devices standard ISO13485 needed medical technology to South African

 General guidelines issued by the MCC that healthcare institutions and patients. In our quest to

impact the Medical Device industry promote such harmonisation in South Africa, we

 The role of the Authorised Representative participate at the Asian Harmonisation Working

 Classification of Medical Devices Party, and the Global Medical Technology Alliance

 Licensing requirements for medical device (GMTA), who give input to the International Medical

companies Device Regulators’ Forum (IMDRF), where

 Site Master File standards of practice for regulation are decided. The

 Guideline for Essential Principles of Safety Committee also interacts with other groupings such

and Performance as Medtech and WHO, among others, to ensure we

are up to date on latest developments for medical

Some of these sessions have attracted more than device regulation.

100 people, which is an indication of the need within

the industry for regulatory guidance. We have The SAMED Regulatory Committee thanks all our

extended the Forums to the Western Cape and Kwa volunteers and experts who have provided SAMED

-Zulu Natal to reach as many members as possible. members with crucial information as we move into a

Finalised regulations for Medical Device licensing more regulated environment for the medical device

and registration are expected to be published industry.

shortly. Several guidance documents for Medical Some highlights from our Regulatory Forums:
Devices have already been finalised.

A recent development has been the formation of the 9
Medical Device Working Group, a specialist sub-

committee of the ITG (Industry Task Group) where
representatives from the regulator and industry will

focus on medical device issues that arise. The first
meeting of this group took place in October 2016.
As draft regulations direct companies to implement

a quality management system, members of the
Committee and other stakeholders met with SANAS

(the South Africa National Accreditation System) at
a forum in September to understand the steps
required to allow companies to become certified



Transformation and Small We look forward to engaging with members on
Business Committee these and other initiatives in 2017.

The main objective of the SAMED: Engaging in Global
Committee for 2016 was to Markets
establish a forum for SAMED

small business members to raise

and discuss issues they are SAMED is supportive of harmonization of standards
and regulatory requirements within the area of
facing in the industry. In addition, Medical Devices manufacture and supply; and to
this end engaged with a number of international
the Committee will focus on agencies this year.

Clive Potter ensuring that the Medical Device Global MedTech Compliance Conference
(GMTCC) held every year brings together device
Transformation and industry is aligned to national and IVD industry regulators, compliance profession-
Small Business als, legal counsels, senior executives and industry
Committee strategic goals to transform the
Chairperson economy. The definition of a

small business has been adopted

according to the BBBEE codes i.e. a business with

an annual turnover of less than R50 million.

One of the key challenges for the Committee observers to analyse and discuss emerging trends
in healthcare compliance and recent challenges and
currently is that meetings are not well attended and to formulate approaches to effectively manage com-
that small business representatives are often not
able to make the time to participate. We will pliance on a global scale.

continue to consider different ways to increase Our executive Officer, Tanya Vogt, was part of a
participation. The Committee has reviewed its panel that discussed the key topic “Procurement in
current objectives and will continue to focus on emerging markets: new compliance challenges”.
these as well as additional objectives for 2017
including creating a database of small owned Third party distributors and compliance still remains
companies (especially level 1-3 B-BBEE compa- a big issue in emerging markets.

nies) and advertising to other members and key

stakeholders, hosting small business breakfasts

with keynote speakers from big businesses to

impart knowledge onto small businesses, encourag-

ing more small businesses to become part of the

committee.

On the 8th of November the Committee hosted a

very informative meeting with a number of expert

speakers that could assist small businesses.

Speakers included Colin Leshou, Gauteng Tanya Vogt, SAMED Executive Director presenting at the Global

Provincial Manager, Small Enterprise Development Compliance Conference 2016

Agency (SEDA) on “SEDA’s offerings and small

business access”; and Pierre Delaney, Director,

KPMG on “Growing a small business: lessons, tips The Global Medical Technology Alliance (GMTA)
and advice”. Some key learnings from the meeting: 69th World Health Assembly (WHA) met from 23

 Ensure you have a good logistics partner. – 28 May 2016. SAMED’s Tanya Vogt participated
 in a panel at World Health Assembly Side-event
They can ensure your products are distributed discussing "Access to innovation for all: Is it
in a safe professional manner and your com-
pany will seem bigger than they are. possible?” The panel explored the current challeng-
es of incentivizing the development of innovative
SEDA can assist companies in a number of
ways including export readiness and facilita- technologies that address the burden of disease
globally, specifically poverty-related and neglected
tion, mentorship and coaching, discounted diseases, while ensuring they are accessible to
rates for SABS testing, technology transfers,
and access to the local market. those most in need.

 Ensure that you have good knowledgeable

people who have industry experience. Recruit 11
the correct people for specific areas in South

Africa to ensure success.

SAMED sits on the Board of the GMTA, a forum MDMSA Members also took part in a very success-
of trade Associations, who also give input to the In- ful DTI funded Arab Health Trade Mission, which
ternational Medical Device Regulators' Forum assisted Members in exposing their products to the
(IMDRF), where standards of practice for regulation Arab Market. Our members will take part in this
are decided. Tanya Vogt attended both the GMTA / event for the second year running in January 2017.
WHO medical device department meeting and the There is however commonality of many of our
GMTA board meeting on the 23rd of May 2016. objectives and that of SAMED, which meant that we
WHO requested support for their regulatory frame- could align amongst others with respect to the
work, which SAMED has given input in to. It was Code, comments on the impact of pending
agreed at this Board meeting to develop GMTA regulations and inefficiencies in Government
common registry principles document. Procurement processes. We had a successful
session for local manufacturers at the SAMED
Tanya Vogt, on behalf of the GMTA was specifically Annual Conference, which focused on local
asked by the Medicine Control Council to speak innovation. MDMSA realized that objectives of the
during the recent pre-conference event, titled board would only be realized through better funding
“Patients are Waiting: How Regulators Collectively of the organization. The DTI assists South African
Make a Difference” at the International Confer- associations with support funding through its various
ence of Drug Regulatory Authorities (ICDRA) schemes. MDMSA prepared a strategic plan and
held on the 27th and 28th of November 2016. Tanya based on the below identified objectives, the DTI
presented on “Industry’s view on regulating medical has approved Sector Specific Assistance Scheme
devices.” funding for the association. This funding will greatly
assist us in meeting objectives in the coming year.
SAMED’s Executive Of-
ficer Tanya Vogt with Ms Objectives identified by MDMSA include:
Monica Eimunjeze, Direc-
tor, National Agency for  OBJECTIVE 1: Market the Association and
Food and Drug Admin- grow the membership.
istration and Control
(NAFDAC) (Middle) and  OBJECTIVE 2: Promote the availability of
Ms Josée Hansen Senior funding and incentive programmes offered by
Advisor, Department of the DTI to support Development. Give input
Essential Medicines and into DTI specific medical device local and
Health Products, World export strategy.
Health Organization

Association News  OBJECTIVE 3: Interaction with relevant
parties to promote development of and
adherence to national and international

regulatory standards and to promote and
encourage among its member’s ethical

principles and practices.

Medical Device Manufacturers of  OBJECTIVE 4: Promote procurement of
South Africa (MDMSA) products developed and manufactured in

South Africa both within SADC and for export

MDMSA, an association member of markets.

SAMED, set itself the objective in
2016 to become the representative  OBJECTIVE 5: Interact with the various
stakeholders in the networks of innovation in
voice for the local manufacturing
South Africa to optimise the development and
industry. This entailed encouraging
local manufacture of innovative, appropriate
more involvement from local
and sustainable medical devices for both local
manufacturing companies through
and export markets.
Malan De Villiers an increased membership, better

MDMSA marketing of the capabilities of local

Chairperson manufacturers, representing the  OBJECTIVE 6: Encourage and grow participa-

interests of local manufacturers in tion of PDI’s in the medical device industry.

negotiations with stakeholders such as government, 12
and facilitating attendance at health and medical We look forward to an exciting
and vibrant 2017!
device congresses.



Medical Imaging Systems Association (MISA) Regular meetings with the NHLS Health Technology

Assessment Unit and SALDA has resulted in

As the MISA, our main objectives are to promote the greater co-operation and understanding of the

interest of our imaging Members. Our 11 Members challenges in our common goal to ensure safe,

are primarily involved in the Medical Diagnostic Im- effective and quality testing for patients.

aging Devices, which are regulated by the Radiation

Control Board via the Hazardous Substances Act. The SALDA/ SAMED Africa committee remains one

of our flagship information sharing platforms which

As we deal with many companies, which have their helps our members to understand the regulatory

own protocols and unique agendas, it sometimes environment of doing business on Africa.

makes it challenging to have quick turnarounds and

final decisions made, so many of our projects are Our goal for 2016 was to set up and complete a

ongoing. Each year we get more information and working database of all government and regulatory

closer to creating more viable market conditions for authorities in East, West, South and North Africa.

our members. Our goal for 2017 is to attract more members from

the other Sub-Saharan countries, in the hopes that

This year, we have continued to engage with our we can promote harmonization in the whole

stakeholders including regular interaction with our Southern African Region.

regulator as well as assisted our members through

the SAMED Regulatory Committee to apply for their During 2016, SALDA members continued to

establishment licence with the MCC. participate in a South African Market survey for

IVDs which has global relevance through Le Club

Our priorities for next year Inter Pharmaceutique Association (CIP), and this

year we saw the survey grow in participants.

Our aim for 2017 is to grow our society by including

more companies in our fold. We still face challenges in terms of harmonized

policies around Point of Care Tests, and are looking

We will strive to be more involved in entities such as forward to the pending National Policy for guidance.

the Radiation Licencing Board, MedTEch, MCC and

SAPHRA, which will enable us to be a more repre- 2017 will continue to be a busy year for us all and

sentative society. we look forward to our engagement with all

stakeholders to identify SALDA's key focus relating
Southern African Laboratory to NHI, over the next 5 years.
Diagnostic Association

(SALDA) CRICE Update

SALDA is a collaboration of 42

members representing multina- The CRICE Programme

tional and local companies is a centralised national

which distribute In Vitro verification programme

Diagnostic tests. We are for Company Represent-

constantly identifying the value atives who enter the

Robyn Howes SALDA of the IVD Industry to keep our Clinical Environment in
Executive Officer
industry relevant to our market South Africa. It is a

and to promote cost savings SAMED initiative

for all patients through new administered by Masoom Training Solutions

and innovative technology.

The CRICE programme continues to expand
This year we have seen the Medical Device and IVD with 403 companies participating to date and
regulatory process come to fruition. The MCC has 8087 enrolments nationally.
called for Medical Device and IVD establishment

licensing. SALDA/SAMED has been hosting month-

ly regulatory forums to inform our members on how

to engage with the licensing process.

SALDA continues to engage with the invited

members of the Laboratory Medicines Group which 14
hosts members of the pathology industry, which
tackles issues such as training capacity and

academic congresses.

The CRICE web platform, www.crice.co.za was PERCENTAGE OF ORGANISATIONS THAT AWARDED IN-
launched at the SAMED Annual Conference in
CREASES IN SALARY WITHIN CERTAIN RANGES FOR
August 2016.
PERIOD UNDER REVIEW

The new CRICE Platform allows companies to: Employee Category

 Use a nifty electronic tool to determine which SALARY General Top Middle Profes- Techni- Low- All
CRICE programme their staff should be IN- Man- Man- Man- sionals cians, er Staff
enrolled into according to the level of access ageme ageme ageme Clerical
required. CREASE & Ad- Level
nt nt nt ministrat
 Enroll one or more members of staff online, RANGE Staff
receive the invoice automatically, make ive
payment and have learning accounts
activated so that the programme can be Under 4% 7 - - - - --
commenced within 48 hours of enrolment.
4.1% to 20 27 33 31 38 21 27
 We created a 'Check your CRICE status tool'. 6% 25 22 28
Companies, Reps and Netcare can use the 13 22 27
CRICE Status Tool to check the status of 6.1% to 27 13 21 32 6 21 -
CRICE completion, document submission and 7% 6 79
card print status. - 7-
7.1% to 26 46 20 19 - --
There are additional nifty changes on the way so 8% 6 -9
keep on checking SAMED newsletters and
www.crice.co.za. 8.1% to 7 7 13 6
9%
To register for the CRICE Programme, please visit
www.crice.co.za. 9.1% to 13 7 13 6
10%

10.1% to - - - -
11%

11.1% to - - - -
12%

12.1% to - - - 6
14%

SAMED 2016 Salary Survey: Key Over 14% - - - - 6 --

Highlights Average Projected Increases

The Annual SAMED salary survey is a major value- The figures shown in Table 2 obviously relate
add for SAMED members. Subsidised significantly by exclusively to organisations that intend to carry out
SAMED, it assists members in making key decisions reviews during this particular 12 month period.

around remuneration and employee benefits. This Working Hours
year, 31 members participated. This is the 15th year A number of organisations have introduced policies
that the Remuneration Survey was conducted on be-
permitting flexible working hours (flexitime) and
half of SAMED. working from home. There is an increased tenden-

Some key findings include: cy in permitting work from home/telecommuting. 44
per cent of organisations indicated that they have a

Actual Salary Increases Granted policy which provides for employees to work from
home.

SAMED members and survey participants’ average Standby Allowances
salary increases were about 1.0% above the aver- 25 per cent of organisations pay an allowance to
age inflation rate of 6.1 % for September 2016. The staff that are required to be on standby (i.e. availa-

weighted salary increases awarded for 2016 was an ble for call-out) during off-duty hours. Note that this
average of 7.1%. This aligns with current national allowance is separate from the amount paid (usually

trends in salary movements. overtime pay) when a call-out is actually required.

Emergency call-out Allowance

17 per cent of participating organisations pay an
emergency call-out allowance.

15

PERCENTAGE OF ORGANISATIONS INTENDING TO SAMED events in terms of adding value to mem-
AWARD INCREASES WITHIN CERTAIN RANGES FOR THE bers’ businesses
PERIOD UNDER REVIEW
1=poor 2=average 3=good 4=excellent 5= don't
attend

Salary Increase Range

EMPLOYEE Nil Under 4.1% to 6.1% to 7.1% 8.1% Over
CATEGORY 4% 6% 7% to 8% to 9%
9%
General
Manage- - 29 50 7 7 7-
ment
- 29 50 7 7 7-
Top Man-
agement - 32 47 7 7 7-

Middle - 32 47 7 7 7-
Manage-
ment

Profession-
als

Technicians,

Clerical & - 32 47 7 7 7-
Administra-
tive As expected, 81.08% of participants voted the
SAMED Regulatory Workshops of most value to

Lower Level - 23 46 their businesses.
Staff
8 15 8 -

ALL STAFF - 25 50 9 8 8 - What SAMED can improve on:

SAMED Benefit Survey 2016  Communication from Committees
Relations with government including aligning
 with government policy to industrialise the

Every year SAMED’s benefit survey assists our medical device industry as was done in the
pharma sector
Board in making strategic decisions for the
More diversity at Board level
upcoming year. We had 40 respondents for this past Obtain more exposure in lay press
Pulling in your associate members so they
survey. Please see the following key highlights: 
can "give something back”
 The feedback that is completed at the meet-

Immediate threats to the sustainability of our  ings, to be sent out like this, but short
versions, then one does not rush and just
companies (in order of importance) write anything, and then you can add value



1. Exchange rate fluctuation and the SA

economy

1. B-BBEE legislation

2. Medical device regulations including the cost

3. Outstanding government payments

4. Government procurement practices including

tender specifications

How satisfied are members with SAMED?

97.5% of the respondents indicated that they were
satisfied to very satisfied with SAMED!

SAMED Committees

Out of the all the SAMED Committees, 97.36% of 16
survey participants voted the Regulatory Committee
good to excellent in terms of effectiveness and
bringing value to their business. This was followed
by the Government Procurement Committee
(64.1%) and then the HE and R Committee (64%).

SAMED Communication: Social Media

Does SAMED need more of a social media
presence?

Which platform should
SAMED use?

Event app

Mobile communications app for
general communications

The Board agreed to look a proposal on a social  communicate and represent, through elected,
network communications strategy which would appointed or designated persons and/or
include a mobile app, Twitter and LinkedIn for structures, the medical device industry's
standpoint on relevant matters and offer
SAMED! advice or make recommendations, within the

Rating of SAMED key objectives as per clause 4 confines of competition law, when the need
of SAMED Constitution arises to anybody or institution whose
decisions and policies might affect the

100% of all respondents stated that SAMED was  industry; and
achieving its key objective (within our constitution) co-operate with governments and regulatory
of “provide a forum for discussion on matters authorities, whether national or international,
affecting the manufacturers, importers and through its officials and structures, as appro-
distributors of medical devices in South Africa, priate.

provided that such discussions are permitted by SAMED has represented the industry’s standpoint
South African competition law.” through the following written and oral submissions

This was closely followed by 87.5% of respondents this year:

indicated that SAMED was achieving the following  A number of motivations to the MCC
key objectives: regarding licencing of Medical Devices

 ensure that all activities of SAMED shall have establishments including:
the best interests of its members as the prima-

ry objective, within applicable legal frame-

works and provided that such shall not unrea- 17
sonably diminish from the needs and rights of

patients;

 A motivation requesting that implantable Movers and Shakers
medical devices and surgically invasive

devices for long term use classified as Ascendis Health is pleased to

Class D be reclassified as Class C announce its new Managing
 A Site Master file specific to medical Director for Medical Devices, Mr

devices for recommendation to the MCC Tony Lowther. With over 16 years’
 A motivation for not having to licence experience in the Medical Device

sub sites and the need for an Authorised industry, Tony is an energetic and
Representative at each site, for recom- passionate business leader with a
consistent and proven track record

mendation to Council of success Internationally across

 Written to the Ministers of Health and Finance world leading companies within the

requesting a meeting to discuss the dire ramifi- Medical Device arena. Ascendis
cations outstanding payments has for the Health has now joined SAMED as
sustainability of our sector. We have received a members and Tony Lowther sits on
response from both departments and
the SAMED Board.

anticipating further clarity on reasonable dates.

 Developed a submission to Davis Tax Commis- BD’s newest Public Affairs Manag-
sion on funding model for the NHI as well as a er, Dr Terence Moodley, is a highly

detailed submission to the NHI White Paper. qualified and motivated individual

 Submission on the Integrated National Strategy seeking to use his unique skills set
for Health Research. to add value with a global
organisation. Terence has worked
 Submission on the Preferential Procurement in the corporate health sector for 9
Regulations for 2016. years and is actively involved in
local industry activities. He has
 In our ongoing engagement with the Health served as chairperson of the MCA
Market Inquiry, SAMED submitted further (Marketing Code Authority), vice-
comments to the Competition Commission

contesting a number of statements made in chair of SALDA (South African

the hearings about the device sector as well Laboratory Diagnostics Association), is a Board
member of SAMED (South African Medical Device
as an oral submission to the Panel.
 SAMED has written to the Council of Medical Industry Association).

Schemes and HPCSA raising our concern SAMED Events 2016
around medical schemes issuing tenders for

the supply of healthcare professional services 2016 was SAMED’s busiest event year yet. With 31

and goods to private hospital groups, which workshops, general member meetings, breakfast
potentially exposes our companies to decision briefings and the annual conference, SAMED has
aimed in assisting members with pertinent develop-
-making in which they have had no say, and
which appears to be purely driven by price ments within our industry. Our successful regulatory
(and not cost-effectiveness, or value-for- forums held with SALDA have been well received by
the members with over 100 attendees at most of the
money, or patient outcomes).
monthly meetings.

Effectiveness of SAMED Board, Executive For the first time in SAMED's history, we hosted the

Officer and office Minister of Health at a breakfast briefing; we

 87.1% of respondents rated the SAMED received phenomenal feedback from our Members.

Board good to excellent

 91.7% of respondents rated the Executive Of-

ficer good to excellent

 94.8% of respondents rated the SAMED office

good to excellent

SAMED has taken all comments, ratings and 18
queries into account and will be ensuring this is
reflected in its 2017 Strategy.

Some positive feedback from our members: SAMED wishes all
our members a
SAMED Annual conference:
happy holiday and
“The theme and topics were appropriate for the a wonderful New
beginning of a truly engaging discussion on the
devices health industry in SA for a robust ethical Year!
environment going into the future”

“The 1st day conference was very informative and I
liked the fact that other countries reps were also
invited and thus we managed to be exposed to
some innovative ways of procurement”

“The event was very informative and I think it is a
good initiative to have such events where different
stakeholders sit and talk towards achieving the

same goal 'caring for the patient”
Other events:

“Thank you for all your efforts put into organising
relevant event”

“Best presentations we have had, thank you!”

“All speakers were strong in delivering their
message. Well knowledgeable and had information
of value”

See below some highlights from our events this
year!

19