South Africa’s Medicines Control Council (MCC) released a draft guideline listing minimum requirements for quality manuals that medical device importers, manufacturers, distributers, exporters, and wholesalers must maintain.
MCC says quality manuals must include information about the facilities, personnel, and quality assurance policies and procedures that demonstrate an organization’s ability to meet the MCC’s regulatory requirements for medical devices.
The manuals must include:
- Company information such as registered name, address, and MCC license details;
- A description of the company’s QMS, including quality control procedures, personnel roles and responsibilities, adverse event reporting requirements, and third-party service providers; and
- Information about each site where medical devices are manufactured or stored, including address, key personnel, security measures, environmental controls, and equipment lists.
For each item to be included in a quality manual, the guideline provides a reference to the corresponding ISO 13485 standard.
MCC is inviting comment s on the draft guideline by April 28.
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