China Food and Drug Administration (“CFDA,” previously known as “SFDA”) issued a draft Notice on Soliciting Public Comments on the Special Approval Procedures for Innovative Medical Devices for Trial Implementation (“Draft Special Procedures”). The Draft Special Procedures provide for a separate approval process aimed at encouraging the development of qualified, innovative products. According to the Draft Special Procedures, medical device manufacturers and their products must meet the following conditions to qualify for the special approval procedures:
- The medical device manufacturer must hold the patent right to the medical device on its own, either as the registrant and owner, or as the owner or authorized user, of the relevant invention patent in China through transfer/assignment.
- The medical device shall have predominant clinical values and incorporate operational principles and functions that are completely new in China, and as compared with leading technologies in other parts of the world. The efficiency or safety of the medical device must be fundamentally improved as compared with similar, existing products.
- The medical device manufacturer must complete the initial research based on a research process that is accurate and well-controlled. Research data must be complete, with clear sources, to generate a fairly mature product.
- The medical device manufacturer must be an enterprise incorporated in China, with a valid medical device manufacturing license, and the relevant product must be manufactured in China.
In order to be qualified for the special approval procedures, the Draft Special Procedures appear to require only "Chinese patents, Chinese developer and manufacturing in China" with respect to innovative medical devices. However, the draft provisions do not appear to prevent Chinese subsidiaries of foreign medical device developers from applying for the special approval procedures.