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ESTABLISHED in 1985, SAMED is increasingly recognised as an integral part of the South African healthcare industry. The association, which represents the interests of over 140 members of the South African medical device and in-vitro diagnostics (IVD) industry, focuses on healthcare matters relevant to its members’ interests. These include encouraging ethical principles and practices within the sector, and providing proactive and effective representation at all levels appropriate to the industry. Furthermore, SAMED undertakes to safeguard and promote the interests of its members.

The association is also committed to:
- creating a favourable environment for the profitable growth of the industry;
- supporting the principle of a free market economic system, which ensures job creation and meets the needs of the population;
- ongoing advancement of SAMED to ensure that it can effectively promote the objectives of its members;
- working with related authorities and associations to ensure that standards and regulatory requirements are relevant, practical and just;

Underscoring the above, SAMED supports the initiative undertaken by the Minister of Health and the Department of Health to ensure that the country’s medical device sector is regulated in terms of the safety, quality and purposefulness of all devices and device establishments in the interest of public health and safety.
The association believes that regulatory intervention in the health sector—as the “reasonable legislative and other measures” mandated by section 27 of the South African Constitution—is the framework within which access to healthcare should be realised for the people of South Africa.

SAMED is a member of the Private Healthcare Forum. It also occupies a place on the National Pharmaceutical Product Interface (NAPPI) Advisory Board, which is responsible for making policy decisions pertaining to allocation of NAPPI codes, and on the board of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) South Africa. SAMED is also the SA industry representative on the Asian Harmonization Working Party (AHWP). The AHWP’s focus is to encourage increased understanding on the benefits of harmonization amongst medical device regulatory authorities and industry organisations regionally and internationally.

Mission and key objectives
EXPANDING on the association’s maxim—“Advancing Innovation Responsibly”—SAMED’s mission is to achieve “the responsible and ethical advancement of the interests of the medical devices industry within the South African healthcare environment, while promoting better patient outcomes”.

With the ultimate goal of achieving improved medical care for South Africans, the association’s key objectives include:
- facilitating and orchestrating negotiations on behalf of its members;
- promoting progress and innovation within the industry;
- providing a source of salient, pertinent and up-to-date industry related information and news; and
- fulfilling the role of industry watchdog where necessary.

The SAMED logo includes an eye-catching icon, which is inspired by the country’s emblematic national flower, the king Protea, and a traditional African gourd. Executed in a clean and contemporary style and colours ¬that are appropriate for the field of medical technology, the concept seeks to communicate the many elements of togetherness, networking, facilitating, mediating, innovation, loyalty and caring for which the association stands.

Benefits of membership
MEMBERS of SAMED enjoy the benefit of being an influentially unified voice that has a dynamic approach to representation in its industry and country. SAMED is an effective conduit that represents the medical device industry on broader healthcare delivery issues. This requires ongoing communication with government and other key organisations that have significant influence over regulations, trading, concerns and public policy affecting the business of healthcare.
Members also have the advantage of receiving insider-type communication relating to both government and private sectors, which ensures that they are always abreast with relevant developments. Where appropriate, the input of members is sought to enable the association to draft constructive strategies and to define proactive initiatives.

SAMED members further benefit from expert advice on regulatory and commercial issues including:
- procurement policies at central and provincial levels; and
- developments with regard the registration of medical devices, both in South Africa and internationally.

Membership to SAMED means that members become part of a large global network of individuals and organisations with an interest in healthcare, which offers countless networking opportunities. The association also receives local and international product and tender enquiries, and a good deal of valuable information relating to various other business opportunities. All such enquiries and information benefit members. Participation in association activities further ensures that members who develop contacts within the industry exchange plenty of valuable information at meetings and workshops.

AMED’s activities and committees are categorised according to key issues that require attention by the association. These are Code of Business Practice; Device Regulation and Registration; Government Supply Chain; Health Technology and Reimbursement Models; Local Manufacturers; Marketing, Communication and Current Affairs; Perverse Incentives; and Orthopaedics.

Code of business practice
UNDERPINNING the association’s vision, the objective of SAMED’s Code of Business Practice committee is to ensure that members adhere to the SAMED Code of Business Practice. The code is clearly defined, effectively promoted, and continuously reviewed and enforced using a process agreed upon by members.

The code is considered an essential guide against which SAMED members can measure business interactions with their customers. While it is not a rulebook, the code offers guidance that is based on distinctive values that include:
- the nurturing of an industry that is socially responsible to its customers, the public at large and patients in particular; and
- the desire to promote a spirit of co-operation and shared responsibility among public and private healthcare professionals and providers. Within the context of effective, efficient and transparent healthcare delivery, this includes the government and other relevant sectors.

Supporting these values, the underpinning principle of the code is that SAMED members will not offer any inappropriate inducement to healthcare professionals or other customers in order to sell, lease, recommend or arrange the sale or lease of their products.

SAMED endeavours to ensure that the code is circulated to all key stakeholders, including healthcare professionals, hospitals, government, tender authorities and benefactors, and that it is accepted as the basis for engagement with these parties.

The Code of Business Practice is binding to all current members, and is a condition of new and ongoing membership to SAMED. It is continuously reviewed, borrowing from best practice both locally and globally. (Much of what appears in SAMED’s code has been adopted from the Eucomed and Advanced Codes of Business Practice, SAMED’s European and American counterparts.)

The code includes a question and answer section to assist SAMED members in its interpretation and practical implementation. Although SAMED urges its members to adhere to the code and to report any infringements to the association’s Ethics Committee, the true mark of success of this code is seen to be the extent to which SAMED members buy-in to it and ensure that their business practices support its objectives.

Recent updates of the code address issues such as the prohibition of rebates, payment for information, shelf space, clinical trials for promotional purposes, registries, bundling and the inclusion of an entirely new section on anti-competitive behaviour.

The committee regularly engages in discussions with organisations and associations such as Medi-Kredit, Pharma, the Competition Commission and the HPCSA.

Device regulations
SAMED’s Device Regulation committee is responsible for influencing the creation of an effective legislative environment in South Africa for the medical devices industry.

Regulations: The committee has extensively researched best practice for device regulations globally and proactively engaged government in drafting regulations.

In light of the recently published amendments to the National Health Act and Medicines and Related substances Act, the efforts of this committee have focused primarily on this initiative. The activities, which many SAMED members have been engaged on, include the drafting of submissions to the Department of Health, compiling presentations to engage and educate various stakeholders around appropriate legislation for the medical device industry and providing key information on Medical Device and IVD regulation to the Ministerial Task team, headed up by Professor Ronnie Green-Thomson.

SAMED supports the introduction of regulations for the medical device and in-vitro diagnostics (IVD) industry in South Africa. In light of this, the Device Regulation and Registration committee recently made the following (summarised) recommendations to the Director-General regarding the Medicines and Related Substances Amendment Bill:

It is SAMED’s opinion that Medical Devices cannot be regulated effectively using legislation originally designed for medicines. In particular with regard to labeling, sampling, licensing of establishments and persons, bonusing, international tendering and renaming.

The Medical Device industry comprises a vast diversity of products, which requires regulations and registration fee structures that accommodate the special needs of the industry.

The Amended Act should make provision for regulations for Medical Devices and in-vitro diagnostic products (IVD’s) that are separate and distinct from medicines and other health care products. IVD’s should have separate regulations, as is the norm internationally.

Timeframes for review of documentation for registration should be set to avoid uncertainty and inefficiencies. Medical Devices do not have generic equivalents. The technology life cycles in the Medical Devices and IVD’s industries are shorter than for medicines, and regulations should accommodate this reality.

For the purposes of planning and continuity of supply, the industry needs certainty regarding which categories of Medical Devices will be grandfathered or subject to sunset clauses, and timelines for call up for registration of various product categories.

Harmonization and alignments with other recognized regulatory authorities internationally would be of benefit to ensure economic efficiencies.

SAMED proposes a single step system of registration, not certification and registration, which may result in inefficiencies and undesirable consequences.

Appropriately qualified experts should be employed to review applications. SAMED does not support the introduction of new economic criteria for registration, as this imposes a second barrier to market entry which is unprecedented in other countries, will cause delays, and limit access to healthcare choices for the SA public. Trade and investment in healthcare in SA may also be affected.

The committee is furthermore involved in ongoing engagement with numerous other organisations such as Advamed, Eucomed, (European Diagnostics Manufacturers Association) EDMA, Radiation Control, The Global Harmonisation Task Force (GHTF) and the AHWP.  SAMED has been profiled as representing the South African Medical Device companies and demonstrated its commitment to improving the environment for the medical device industry in South Africa and in the global market place.

Government supply chain
The key objective of SAMED’s Government Supply Chain is to partner with government to overcome shortcomings of the supply chain management (tender) system. The working group also assumes the responsibility for reporting all contraventions of current legislation regarding the Government Supply Chain Policy.
Recent activities include a survey, which was conducted among SAMED members to determine problems encountered in the Government Supply Chain, in particular outstanding payments.

The committee aims to have regular contact with government officials, such as the National Treasury and Provincial Departments of Health.

Health technology and reimbursement models
THE Health Technology and Reimbursement Models committee seeks to establish initiatives to improve transparency and efficiency in accepting new reimbursable technologies. It also promotes the value of Pragmatic Evidence Evaluation to achieve continuous improvements in healthcare for patients. The committee furthermore oversees the research and proposal of industry guidelines pertaining to reimbursement models on behalf of SAMED.

Recent undertakings by the committee include research into local and international re-imbursement models, and the importance and value of new technologies. It developed a draft positioning paper outlining a protocol proposed for adoption by all stakeholders. The key challenges of this protocol are:
- getting clinical acceptance via evidence and endorsements from the user group;
- ensuring devices are not used in applications beyond their scope of proven use;
- making certain that Pragmatic Evidence Evaluation is not seen as a cost driver;
- certifying that appropriate evidence-based strategies are applied; and
- ensuring clinical policy information is made available in the public domain to encourage transparency.

The committee believes that Health Technology Assessment (HTA) is what local funders claim to do. The Health Technology and Reimbursement Models team prefers a more pragmatic approach which is based on the premise that international HTA methodology may differ widely and may be inappropriately applied across foreign markets i.e. a bias towards the assessment methodology use for drugs. SAMED believes this methodology is inappropriately used for devices and technologies.

Local practice, which also differs widely, has become yet another obstacle to reimbursement, driven largely by managed care principles/regulations. The outcome, says SAMED’s Health Technology and Reimbursement Models committee, has been confusion and inconsistency within the device industry with regard to the question of how to get a technology reimbursed.

As a result, what SAMED has produced is a position statement on Pragmatic Evidence Evaluation, its relevance (or not) to devices, based on inherent characteristics and a proposed “pragmatic” approach.

The objective therefore is to produce guidelines to assist suppliers with a systematic approach to applying for reimbursement, which is something that should more than meet the information requirements for local funders at this stage.

In summary, the committee lists as recent milestones:
- white paper on Pragmatic Evidence Evaluation and reimbursement published for comment and work shopped with SAMED membership;
- white paper adopted by Qualsa;
- working with Discovery on incorporating SAMED’s guiding document into their PIN process – these discussions are ongoing; and
- presentation of the SAMED white paper to the Department of Health and other medical aid schemes.

Local Manufacturers
THE key object of SAMED’s Local Manufacturers committee is to support the growth and sustainability of a local medical device manufacturing industry in South Africa.

The committee engages in ongoing liaison with the Department of Trade and Industry and SABS regarding support for the local manufacturing industry. Other key topics addressed by this team include:
- CE mark and quality management systems;
- the impact of Broad-Based Black Economic Equity (BBBEE) and Preferential Procurement on local manufacturers;  
- the requirements of local manufacturers in terms of Draft Medical Device Regulations; and
- certification, standards and accreditation for ISO 13485.

Marketing, communication and current affairs
The Marketing, Communication and Current Affairs committee promotes and markets the value of the medical device industry and SAMED. It is also responsible for providing members with regular and relevant information about developments in the local and international medical devices arena.
The committee has redesigned SAMED’s website to incorporate the new corporate identity, prepares a quarterly SAMED newsletter.

Orthopaedic sub-committee
The SAMED Orthopaedic Sub Committee is a joint initiative between the orthopaedic trade (via SAMED) and the South African Orthopaedic Association (SAOA), whose members are orthopaedic surgeons.

The sub-committee represents a unique opportunity for healthcare professionals in the orthopaedic sector to collaborate with members of the trade on initiatives that provide mutual benefit, and which advance patient care.

SAMED. Tel +27 (0) 11 467 0855. Fax +27 (0)11 467 1697.
E-mail tanya@samed.org.za. Website www.samed.org.za