The State Food and Drug Administration (“SFDA”) in China published a draft of the Tentative Measures for the Administration of the Registration of Re-Packaging In-Vitro Devices (IVDs) (“Draft Measures”) on November 2 for public comments through November 20. The Draft Measures define re-packaging of IVDs as the activities undertaken by a domestic medical device manufacturer to arrange exterior packaging of bulk IVDs produced in accordance with the regulatory specifications approved by SFDA into the smallest sales units; placing Directions-for-Use (“DFUs”) or labels on the IVDs are not considered re-packaging under the Draft Measures. In addition, certain high-risk IVDs whose Quality Management Systems (“QMS”) or GMP system is to be certified by SFDA are not eligible for re-packaging pursuant to the Draft Measures.
A domestic medical device manufacturer may apply for a re-packaging license for IVDs duly registered in China with the competent provincial FDAs or SFDA. The applicant must be a medical device manufacturer with a valid medical device manufacturing license covering the IVDs to be intended for re-packaging as well as a valid QMS/GMP certification. The applicant must also obtain an authorization from the manufacturer of bulk IVDs and enter into a quality assurance agreement with the same manufacturer specifying the quality metrics, testing and delivery acceptance requirements. The manufacturer of bulk IVDs shall conduct an on-site due diligence of the manufacturing facilities of the applicant and apply for a product registration or license amendment with the competent provincial FDAs or SFDA for the bulk specification of the IVDs in question.
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