SFDA Interprets Issues Concerning Cross-Provincial M&A Involving Medical Apparatus Manufacturers
On June 2, 2009, the State Food and Drug
Administration (the "SFDA") released the Reply on Issues Concerning
Cross-Provincial Mergers and Acquisitions of Medical Apparatus Manufacturers
(the "Reply"). According to the Reply,
in the event that a medical apparatus manufacturer acquiror purchases another
medical manufacturing enterprise in a different province, and thereafter
applies to change its registered address to the address of the acquired entity,
the application must be examined and approved by competent authorities in
accordance with Article 21 of the Administrative Measures for the Supervision
of the Manufacturing of Medical Apparatus ("Article 21"). If the acquired enterprise is still
registered as an "independent manufacturer" following the acquisition
("independent manufacturer," as is stipulated in Article 21, refers to a
manufacturer that maintains a separate business license and is able to bear
civil liability independently), this acquired entity, rather than the acquiror,
shall apply to its local authority for a change to the Medical Apparatus
Manufacturer License and the Medical Apparatus Registration Certificate of the
acquiror. If the acquired entity is no
longer an independent manufacturer after the merger, the acquiror must apply
for renewal or initial registration of its own Medical Apparatus Registration
Certificate. Although not stipulated in
the Reply, relevant authorities interpret the Reply as being applicable to all
medical apparatus manufacturers in China, including foreign-invested
manufacturers, and all affected parties should ensure compliance.
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