Medical Device Establishment License Renewal

Medical Device Establishment Licenses are valid for a period of five years, after which they have to be renewed. Since many companies who met the original 2017 deadline for licensing are now coming up for renewal, SAHPRA have issued a guideline in this regard.

The process to be followed is materially the same as for the original application with some important differences:

• A CV of the authorised representative has to be submitted
• Only Wholesalers require a Site Master File, Manufacturers and Distributors require a Quality Manual
• Either ISO 13485:2016 Certificate or a declaration signed by the Authorised Representative
• Proofs of payment for Retention Fees Paid. (Note that Retention fees are payable by 30 June each year)
• Proof of payment for the Renewal Fee, published in the Government Gazette

Documents related to Medical Device Establishment License Renewal

Further information is available on the SAHPRA website.

Mark Banfield is an independent specialist Consultant in the Health Technology sector, offering consulting and advisory services in Business Development, Market Research, Quality Assurance and Regulatory Compliance.