Challenges for South African Medical Device Manufacturers

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Claribel Martin
6 years ago
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1 Challenges for South African Medical Device Manufacturers Malan De Villiers Chairman: MDMSA March

2 Local regulatory picture.. Medical Device companies face an increasing number of global regulatory requirements to address product safety. The diversity of Medical Devices, the iterative nature of product development, the increasing use of modern technologies in embedded devices and the relatively short product life cycle make manufacturing of Medical Devices a challenging task.

3 Local regulatory picture Increased regulatory oversight is imminent Attention to quality and regulatory requirements are critical in the Medical Device industry as a means to minimize product recalls and legal costs while meeting patient health goals of affordability and safety Local vs International standards and specifications SANS vs EN vs ISO

4 Regulatory environment EEA (European Economic Area) Member State/ Country EU: England EU: Germany RSA Law/Regulation Competent Authority European Commission: MDD 93/42/EEC Changing to two Regs: MD and IVD (early 2017 for full implementation 2020) MHRA BfArM Accreditation bodies UKAS ZLG: Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten Notified Body/Conformity Assessment Body (CAB) Act 101, 1965; General regulations relating to medical devices and in vitro diagnostic medical devices MCC (SAHPRA) SANAS i.e. BSI or LRQA i.e. Dekra? BSI, TUV SUD, LRQA, Dekra SABS? Product regulatory approval CE mark CE mark Product registration

5 Local Manufacturers Current membership of MDMSA comprises 33 companies and organisations participation. A collection between exporters, NPO s Parastatals, consultants PDI s participation. Members PDI Exporters Parastatals NPO Multinationals Consultants

6 Local Manufacturers perspective The organisation s vision is to make the Medical Device Industry a vibrant industry to meet the challenges that are faced by both the local and global economies. The primary objective would be to protect and grow the industry for the benefit of all within the Republic of South Africa. (MDMSA CONSTITUTION)

7 What is a medical device?

8 Unlike medicines, the variation in medical device product types is vast....from simple to complex, from low risk to high risk technologies. Regulation must reflect the differences in medical device types. Regulation cannot simply follow medicines regulation

Definitions any instrument, apparatus, appliance,

Implantable, IVD Medical equipment Accessories with

9 Definitions any instrument, apparatus, appliance, material or any other article, whether used alone or in combination. Medical Devices Non-invasive, Invasive, Active Implantable, IVD Medical equipment Accessories with a medical purpose Custom-made Devices Devices for Clinical Investigation Systems and Procedure Packs

10 Definition of Manufacturer the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name regardless of whether these operations are carried out by that person himself or on his behalf by a third party Own Brand Manufacturer (OBM) A company or person who places on the market under their own name a device already CE marked by an OEM Original Equipment Manufacturer (OEM) Assemblers, Packers, Sterilizers, Re-processors

11 Current local manufacturing Consumables Surgical sterile tray packs, Sterile pouch device packs for theatre Sterile Basic Trays and Packs i.e. Dressing Trays Elastic Adhesive bandages, Rigid strapping tapes, Gauze swabs and dressings

12 Current local manufacturing Consumables Sanitary towels, Plaster of Paris bandages hydroconductive wound dressings Surgical Sutures, Safety Scalpels Disposable surgical drapes and gowns

13 Current local manufacturing Sterile intravenous solutions Orthopaedic equipment and implants Spirometry, Venting Filters, Anaesthetic Ventilator Filters Filters, Spatterguard, Flowguard, One Way, cardboard Mouthpieces

drills Decontamination, Surgical Support, devices

14 Current local manufacturing Trauma products such as bone screws, plates, bone plate bending presses, drills Decontamination, Surgical Support, devices Chest & Urinary drainage Dental implants Orthopaedic implant devices

15 Current Manufacturing IVD & Other rapid test - a simple easy to use test IV device. Diagnostic test kits for point of care rapid diagnostics Urine Analysis & Adulteration Tests Lifestyle & Lateral Flow Rapid Tests Specialised Wheelchairs mobile clinics Infection Control Products

Uroflometry, Urodynamics Suction & oxygen therapy equipment Neo-natal equipment & Fluid warming cabinets Equipment mounting systems Medical Service Supply Units Current Manufacturing Highcare and

16 Uroflometry, Urodynamics Suction & oxygen therapy equipment Neo-natal equipment & Fluid warming cabinets Equipment mounting systems Medical Service Supply Units Current Manufacturing Highcare and Intensive Care equipment, accessories, screens and Accessories Endo-urological, Medical Aesthetic and Urological Laser sectors Suction waste collection systems, suction catheters, suction probes and other suction devices Generic equivalent infusion sets Equipment

17 Purpose of Regulations Ensure products are safe and perform to the intended use Clinical evidence to support claims Enforce control and management of products

18 Purpose of Regulations The safety and performance of medical devices depend on two critical elements: 1.Pre-market review contributes to product control 2. Post-market surveillance ensures that medical devices in use continue to be safe and effective. A third element, control of the representation of the product to the user - Label, advertising and education

Industry strongly supports a legislative framework that ensures that South African patients have access to medical devices that are safe, effective and of good

19 Industry strongly supports a legislative framework that ensures that South African patients have access to medical devices that are safe, effective and of good quality the promulgation of regulations that are: appropriate for the South African market, that leverage on international experience Industry view on Regulator Requirements

20 MCC

21 Dec 2016 Status is currently at stage 1: Establishment License

24 Purpose of Regulations The safety and performance of medical devices depend on two critical elements: 1.Pre-market review contributes to product control 2. Post-market surveillance ensures that medical devices in use continue to be safe and effective. A third element, the representation of the product to the user - Label, Advertising and Education/ Training

25 Impact on the Sector Regulations may well change the landscape of our industry and some companies may not be able to comply with additional costs for an Authorised representative, Establishment Licence, Product Registration and QMS development & Implementation MCC has communicated that the establishment license is only due 6 months from gazette of the regulations / government notice (10 th Dec 2016)

26 What will the Medical Device legislation cover

28 Local Regulations challenges No local accredited conformity Assessment Body (CAB)/ Notified Body (NB) Potential costs of licencing the company and registration of product (small number of products/ range resulting in less amortization of costs by group / family volumes that many importers have) Few local testing facilities - overseas testing at higher costs

29 Local Regulations challenges Less access to local components / materials = overseas suppliers e.g. medical grade paper for packaging Possible MCC inspection cost, with additional provisions for Local Manufacturers Timelines for CAB (Conformity Assessment Body) certification, Organisation licencing and product registration

30 Conclusion Local manufacturers welcome regulations: It will level the playing field It will improve patient safety However, local manufacturers are concerned about: Inappropriate regulations Requirements that are not harmonised Long Registration times Costs

31 THANK YOU 31

Medical Device Regulatory Framework 9 SEPTEMBER 2015 FUNDISA CONFERENCE JANE ROGERS

Medical Device Regulatory Framework 9 SEPTEMBER 2015 FUNDISA CONFERENCE JANE ROGERS Key Topics Definitions Essential Principles Classification Conformity Assessment Framework License to Manufacture, Import,