CONTENT PERSPECTIVE OF LOCAL MANUFACTURE LOCAL MANUFACTURERS PERSPECTIVE EFFECT OF REGULATIONS ON LOCAL MANUFACTURE

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2 CONTENT PERSPECTIVE OF LOCAL MANUFACTURE LOCAL MANUFACTURERS PERSPECTIVE WHAT IS MEANT BY LOCAL MANUFACTURING CHALLENGES EFFECT OF REGULATIONS ON LOCAL MANUFACTURE HARMONISATION TIME FRAMES COSTS

3 PERSPECTIVE OF LOCAL MANUFACTURERS GARAGE / BACK YARD OPERATIONS SUBSTANDARD AND INFERIOR INCOMPETENT

4 SIMPLY NOT TRUE THERE ARE WORLD CLASS MANUFACTURING FACILITIES IN SOUTH AFRICA MANY LOCAL MANUFACTURERS ADHERE TO INTERNATIONAL REGULATIONS EUROPE USA OTHERS SOUTH AFRICANS DO HAVE THE REQUIRED SKILLS AND COMPETENCIES MOTOR AND AERONAUTICAL INDUSTRIES MEDICAL INVENTIONS AND DEVELOPMENTS BY SOUTH AFRICANS

5 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)

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 MEANT WITH LOCAL MANUFACTURE? DESIGN AND MANUFACTURE INNOVATIVE MEDICAL DEVICES IN SOUTH AFRICA TRUE MANUFACTURERS MANUFACTURE MEDICAL DEVICES IN SOUTH AFRICA ENCOURAGE IMPORTERS TO MANUFACTURE IN SOUTH AFRICA SOUTH AFRICAN SUBCONTRACTORS FOR INTERNATIONAL COMPANIES DESIGN MEDICAL DEVICES IN SOUTH AFRICA DEVELOP THE NECESSARY INFRASTRUCTURE TO SUPPORT MEDICAL DEVICE MANUFACTURING

8 CHALLENGES SOUTH AFRICA IS NOT A MANUFACTURING FRIENDLY ENVIRONMENT ELECTRICITY LOAD SHEDDING LABOUR LEGISLATIVE CHALLENGES WATER SUPPLY?

9 CHALLENGES INFRASTRUCTURE AND SUPPORT SERVICES CERTIFIED AND VALIDATED STERILISATION FACILITY? PACKAGING SYSTEMS COMPLYING IN FULL WITH ISO 11607? CLEANROOM CONTRACTORS COMPLYING TO ISO 14644? ACCREDITED LABORATORIES FOR BIOBURDEN, STERILITY, BIOCOMPATIBILITY AND OTHER TESTING? ETC

10 EFFECT OF REGULATIONS ON LOCAL MANUFACTURE PATIENT SAFETY CANNOT BE COMPROMISED, YET THERE IS A THIN LINE BETWEEN EFFECTIVE REGULATING AND BUREAUCRACY THE DIFFERENCE BETWEEN REAL CONCERNS AND SCIENCE FICTION DOES THE REQUIREMENT IMPROVE PATIENT SAFETY OR DOES IT JUST INCREASE ADMINISTRATIVE BURDEN?

11 EFFECT OF REGULATIONS ON LOCAL MANUFACTURE REGULATION THAT IS OVERZEALOUS IS A PATIENT RISK. IF IT IS IMPOSSIBLE FOR COMPANIES TO COMPLY, THERE WILL BE NO MEDICAL DEVICES AVAILABLE. INAPPROPRIATE REGULATIONS WILL NEITHER Patient Safety Sustainability SERVE THE PATIENT NOR THE INDUSTRY REGULATIONS SHOULD NOT KILL INNOVATION

12 LOCAL MANUFACTURERS REGULATORY CONCERNS Harmonisation Costs Time Frames

13 HARMONISATION UNNECESSARY UNIQUE REQUIREMENTS OR STANDARDS COMPLICATE COMPLIANCE AS ALL REGULATORY REQUIREMENTS FROM ALL MARKETS ARE NON- NEGOTIABLE. COMPLICATE EXPORTS BURDEN RESOURCES AND DUPLICATE EFFORTS INCREASE COST MAY REACH THE POINT WHERE THE DEVICE IS TOO EXPENSIVE TO BENEFIT THE PATIENT.

14 UNIQUE STANDARD EXAMPLE ESSENTIAL PRINCIPLE: THE COMPATIBILITY BETWEEN THE MATERIALS USED AND BIOLOGICAL TISSUES, CELLS, BODY FLUIDS AND SPECIMENS; THE FOLLOWING STANDARDS DESCRIBE MEDICAL GRADE 4 TITANIUM. ISO (GENERALLY RECOGNISED ALL OVER THE WORLD) ASTM F 67 (WIDELY ACCEPTED, MAY BE REQUIRED BY USA) GB/T (CHINESE STANDARD, NOT RECOGNISED ELSEWHERE) USING TITANIUM MEANS NONCOMPLIANCE IN OTHER MARKETS BUT CHINA. IF THIS IS A REQUIRED STANDARD FOR CHINA, IMPLICATIONS CAN INCLUDE: THE CHINESE MATERIAL AND OTHER MATERIAL NEED TO BE CONSIDERED IN TECHNICAL FILE. PRODUCT FROM BOTH MATERIALS WILL BE REQUIRED POTENTIAL MIX-UPS AND POTENTIAL RECALL RISK

15 TIME FRAMES LONG REGISTRATION AND/OR APPROVAL PERIODS WILL DESTROY LOCAL MANUFACTURERS. NEW PRODUCT DEVELOPMENTS TAKE A LONG TIME AND IS VERY EXPENSIVE. IT IS IMPORTANT TO RECOVER THIS INVESTMENT AS SOON AS POSSIBLE. ITS A CONCERN IF A MANUFACTURER CANNOT SELL IN IT S COUNTRY OF ORIGIN. CE APPROVAL TAKES APPROXIMATELY 90 DAYS. THERE ARE PROVISIONS TO OBTAIN CE APPROVAL WITHIN 15 DAYS. OFTEN A CERTIFICATE OF FREE SALE IS REQUIRED FOR MARKET ACCESS. LOCAL MANUFACTURERS DON T HAVE THE RESERVES OR RESOURCES THAT MULTINATIONALS DO.

16 COSTS THERE IS OBVIOUSLY A LOT OF PRESSURE ON MANUFACTURERS TO KEEP THE COST OF THE MEDICAL DEVICE AS LOW AS POSSIBLE. HTA MEASURES THE COST OF THE DEVICE AGAINST OTHER TECHNOLOGIES CERTIFICATION; REVIEW / EXAMINATION; AUDITS; LICENSING AND REGISTRATION CAN EASILY EXCEED R1 MILLION IN A YEAR. THESE COSTS NEED TO BE RECOVERED. MAINTAINING QUALITY SYSTEMS, TECHNICAL FILES AND OPERATIONS IS VERY EXPENSIVE. HIGH END PROFESSIONALS, ENGINEERS, REGULATORY AFFAIRS, QUALITY PROFESSIONALS IT IS THEREFORE OF UPMOST IMPORTANCE TO STREAMLINE REGULATORY PROCESS AND COMPLIANCE STANDARDS AS FAR AS POSSIBLE.

17 CONCLUSION LOCAL MANUFACTURERS ARE CAUTIOUSLY OPTIMISTIC ABOUT REGULATIONS COMING SOON. 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

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