To further standardize the definition of the attributes of Drug/Device Combination Products, according to the Three- Determinations (of posts, duties and staffing) regulations for NMPA institutions, on May 31, 2019, NMPA announced the relevant matters as follows:
I. The NMPA Management Center for Medical Device Standards (hereinafter referred to as the Management Center for Standards) shall be responsible for organizing the attributes-definition.
II. The applicant submits an application for attributes-definition to the Management Center for Standards via the Definition Information System for Attributes of Drug/Device Combination Products (see Annex for details).
III. The Management Center for Standards conducts a preliminary review of the application dossier for attributes definition. If it meets the requirements, it shall be accepted; otherwise, the applicant shall be notified to make corrections, or the application shall be rejected.
IV. The Management Center for Standards shall review the accepted application, and give the opinions on attribute definition within 20 working days, and inform the applicant. Experts can be organized, where necessary, to study and proffer technical recommendations for product attributes. The time required for supplementary dossiers and expert discussions shall not be counted in the time limit.
V. Where additional information is required, the applicant shall make a one-time supplement within 60 working days as required. If the supplementary dossiers are not submitted within the time limit, or if the applicant fails to submit such dossiers as required, the application shall be rejected.
VI. Where the applicants disagree with the attribute-definition outcome, they may request for a re-review to the Management Center for Standards within 10 working days as from the date of being informed of the definition results. The Management Center for Standards shall organize a re-review, the opinions of which shall be final for attributes definition.
VII. The Management Center for Standards shall publish the results of attributes definition on its website in a timely manner.
VIII. Other registration issues of Drug/ Device Combination Products shall be handled in accordance with the Announcement on Matters Concerning the Definition of the Attributes of Drug/ Device Combination Products (SFDA Announcement No. 16 of 2009).
IX. This Announcement shall enter into force as from June 1, 2019.
