The Department of General Affairs of the National Medical Products Administration ("NMPA") has recently issued the Circular on Matters Concerning Adjusting the Determination of Attributes of Drug-device Combination Products (Draft for Comment) (the "Draft for Comment") for public consultation by May 17, 2019.
The Draft for Comment provides that the Medical Device Standard Management Center ("Standard Management Center") of the NMPA takes charge of organizing the determination of attributes of drug-device combination products, adding that an applicant may submit an application through the Information System for Determination of Drug-device Combination Product Attributes to the Standard Management Center for the determination of a drug-device combination product's attributes. Meanwhile, the Draft for Comment expressly states that the Standard Management Center will conduct preliminary reviews of application documents for the determination of drug-device combination products' attributes it has received, and will accept the applications if requirements are fulfilled; otherwise, it will notify the applicants to provide additional information or make corrections, or dismiss the applications. The Standard Management Center will then examine the applications for the determination of drug-device combination products' attributes it has accepted, give its opinions within 20 working days, and inform the applicants of such opinions. The Standard Management Center will make public, in a timely manner, on its official website results regarding the determination of drug-device combination products' attributes.