The National Medical Products Administration ("NMPA") has recently issued the Procedures for the Special Evaluation of Innovative Medical Devices (the "Evaluation Procedures"), effective immediately from December 1, 2018.
The Evaluation Procedures mainly clarify patent-related requirements, means to inform enterprises of and contents of evaluation results, ways to communicate with enterprises, and other matters, among procedures for the special evaluation of innovative medical devices. Further, the Evaluation Procedures specify that, in light of the situation that some applications involving patents for invention of core technologies have been published by the administrative department of patent of the State Council but the patent rights are not granted eventually, efforts will be stepped up to conduct the preliminary evaluation of products' core technical programs. An applicant may file a search application to the Patent Search and Consultation Center of the National Intellectual Property Administration ("CNIPA"). Meanwhile, in consideration of characteristics of patents and the average period of time needed to research and develop a type of medical device, it is decided that the gap between the time to apply for the special evaluation of a type of innovative medical device and the date of announcement concerning the granting of the patent right, shall be up to five years. Moreover, the Evaluation Procedures expressly state that, as Class I medical devices are subject to administration by record-filing, these procedures do not apply to them.
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