New Medical Device Regulations have been published for comment.
Mark Banfield and Associates Consulting and the Medical Device Professional Group have commented on these regulations and hope that our comments will be taken on board by SAHPRA.
Key comments and observations are:
- The definition of “As determined by Council [the Authority]” has been omitted, which means that SAHPRA is not obligated to publish their decisions in the Government Gazette. Unfortunately this has been a major problem for industry which leads to arbitrary decisions being implemented without due process or effective communication or consultation with industry.
- Guidelines, position statements, communication to industry and media statements should provide clarification and aid communications. These documents cannot create requirements which are not supported in law. This requires proper clarification and definition of the role of these documents.
- Alignment with Economic Operators with other competent authorities as the current regime of “Wholesaler”, “Distributor” and “Manufacturer” result in regulatory gaps, duplication of license requirements and misalignment in terminology. ie Wholesalers cannot export without a distributor license, and distributors and manufacturers cannot procure medical devices locally without a wholesaler license and no provision is made for dispensing clinicians or retailers.
- Authorised Representatives are limited to Natural persons and employed by a single license holder, irrespective of company structure. it would be better to align with the the definition and application of Authorised Representative in the European Union, which will also aid in meeting the underlying objectives of having Authorised Representatives.
Substantive comments may be read in the following documents:
Mark Banfield is an independent Health Technology Consultant, providing consulting and advisory services in Business Development, Market Research, Quality Assurance and Regulatory Compliance.