Patent Strategies For Chinese Approval Of Medical Devices

By Aaron Wininger, Douglas Portnow and Bin Zheng (January 30, 2020, 3:59 PM EST) -- The National Medical Products Administration of China issued special review procedures for innovative medical devices in November 2018, effective Dec. 1, 2018. The procedures enable expedited regulatory approval of innovative medical devices when the applicant owns or licenses Chinese invention patent applications directed to the medical devices seeking approval.

Requests for participation in the special review program will be issued within 60 working days and have an opposition period of 10 working days. Once requests are approved, applicants can request expedited regulatory device approval within five years of the approval.

Official data for 2019 has not be released yet. But by...

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