Interpretations of the Relevant Issues Concerning the  Special Approval of Innovative Medical Device

Issued on July 31, 2017

1. Application time for the special approval of innovative medical devices

According to the "Innovation Procedures", if the registrant has applied for the special approval of innovative medical device before the registration application, the CFDA would handle it in accordance with the "innovative procedures".

2. Whether the Class 1 medical device in accordance with the "innovative procedures"?

According to the “Regulations on the Supervision and Administration of Medical Devices” (State Council Decree No. 680), Class 1 medical devices are for the record management not subject to administrative licensing matters, so the class 1 medical devices do not available for the "innovation procedures".

If the class 1 medical devices are applied for special approval of innovative medical device, the CFDA will not accept it; If the application for special approval of innovative medical device has been accepted by the CFDA, The product is defined as the Class 1 medical device after the CFDA review, the application would not in accordance with the "innovative procedures" for approval.

3. Whether renewal registration / permission changing registration available for the "innovation procedures"?

According to Article 12, Article 14, Article 17 of the "Innovation Procedures", the special approval of innovative medical devices only applies to the first registration cleared in the "Medical Device Registration Management Measures" (CFDA Order No. 4), "in vitro diagnostic reagents Registration of Management Measures "(CFDA Order No. 5), it does not available for the renewal registration or permission changing registration.

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