Last year, China released the “Procedure for Examination and Approval of Innovative Medical Devices (Trial)”, which went into effect on March 1, 2014. The Chinese Food and Drug Administration (CFDA) defined certain conditions that the applicant must fulfill in order to qualify for the fast track approval process. First, the applicant must be a legal entity in China. The medical device must be manufactured with a legal Chinese license and the applicant must own the intellectual property in China. Furthermore, the device itself must also qualify for this fast track approval procedure. It must be the first of its kind in China functionally. It must provide significant improvement in safety or efficacy compared to the currently available therapies. Finally, the medical device must have a significant clinical application value.
A key issue for this procedure is related to the definition of “innovative medical devices”. In accordance with the dispositions of the CFDA, a medical device can be considered “innovative” if it meets with one of the following three qualifications:
- The invention patent has been obtained in China or the applicant has acquired inventive patents as a transferee. Moreover, the invention patent application has been applied for and made public by Chinese patent authorities.
- The innovative activities must be in or acquired in China and the technology must be superior. This means that the company must be an international leader.
- The research process must be genuine and the data must be compete and traceable.
During the last few months, the CFDA has released marketing authorization approvals for two new medical devices in accordance with the “Fast Track Approval Process for Innovative Medical Devices”. The approvals were for Shenzhen AiNear Cornea Engineering Company’s acellular corneal medical device to restore stroma integrity and for Beijing CapitalBio Corporation’s nucleic acid amplification microfluid chip analyzer. The time that elapsed from submission to approval spanned just 4 months and 22 days.
Unfortunately, while many foreign device companies believed that this would expedite registration in China, only foreign companies that meet the criteria mentioned above will be considered for fast track approval. This means that for 99% of foreign device manufacturers, this new regulation will not help to speed up the registration for their product in China.