SAHPRA recently announced that the Section 36(1) Exemption requiring medical device companies to be ISO13485 Certified by before Medical Device Establishment License renewal, for a further three years.
Licenses are valid for a period of five years, and it was expected that companies would implement and certify their Quality Management Systems within this “grace period”.
However, during this time only one company was accredited by SANAS to certify ISO13485. SAHPRA also failed to conclude recognition agreements with any of the large multinational certification or conformity assessment bodies. it was therefore extremely difficult for medical device companies to comply with the requirements even given this grace period.
Authorised Representatives are legally responsible for the medical device companies they represent and are required to sign all application forms, which include a declaration that the company has implemented a Quality Management System (QMS). Despite this, we still find that many companies have not actually implemented a quality management system, and those which have, may not comply with the requirements.
MD031 also provides for additional requirements when renewing Medical Device Establishment Licenses: Authorised Representatives will have to provide a copy of their Quality Manual and a signed Declaration that they have implemented ISO13485.
Failure to have done so will mean that your renewal application will be rejected and misrepresentation in any form could result the license being revoked and criminal action taken against the Authorised Representative and the medical device company.
If you have not yet implemented ISO13485, contact Mark Banfield to assist with your implementation; don’t miss this important deadline.
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More infomartion may be obtained on www.sahpra.org.za
Mark Banfield is an independent Consultant specialising in Health Technology and providing consulting and advisory services in Business Development, market research, Regulatory Compliance and Quality Assurance for medical devices.