On June 2, 2009, the State Food and Drug Administration of the PRC (SFDA) issued a letter to clarify the procedural rules relating to change of address applications filed by medical device manufacturers that conduct cross-province mergers and acquisitions. The letter is entitled Reply on Relevant Issues Regarding Cross-Province Mergers of Medical Equipment Manufacturing Enterprises, which SFDA issued in response to the Shanghai Food and Drug Administration’s inquiries.
The Reply indicates that a competent authority can approve an enterprise’s application for a cross-province address change in accordance with Article 21 of the Measures for the Supervision and Administration of Medical Device Manufacturing as long as the enterprise conducts a 100 percent acquisition and satisfies relevant regulatory requirements on production and management.
According to the Reply, if an enterprise establishes a cross-province manufacturing site to produce the same products as listed in its medical device registration certificates and does not form an independent manufacturing enterprise, the enterprise should re-register the products according to the Measures for the Administration of Medical Device Registrations. If the enterprise uses the cross-province manufacturing site to produce medical devices listed in other companies’ medical device registration certificates, it must apply for initial registration of the medical devices.
The Reply further provides that, if an enterprise establishes a cross-province manufacturing site and forms an independent manufacturing enterprise, it must file an application to modify its Medical Device Manufacturing Enterprise Permit and medical device registration certificates.