Licensees are not required to make application for amendment of a medical device establishment licence in the event of a change in the product listings provided in section 4.1, 4.2, 4.3, 4.4 and 17.3 of the manufacturers and distributors licence application form and section 3 of the wholesaler’s application form: Provided that the class of medical device/s for which the licensee has been licensed is not affected and does not change.
In the event of a change to section 4.1, 4.2, 4.3, 4.4 and 17.3 of the manufacturers (6.21) and distributors (6.22) licence application form and section 3 of the wholesalers (6.26) application form that does not affect the class of medical device/s for which the licensee has been licensed, the licensee is required to notify the Authority in writing – subject to the criteria set out by SAHPRA.
No fees will be levied in this regard.
All other changes to the product listing are subject to an amendment and associated fees (visit the SAMED website for the fee schedule).
