Chinese FDA Soliciting Public Comments on Rules for Re-Packaging of IVDs


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.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.