Methods for the Administration of Medical Device Registration (State Food and Drug Administration Bureau Decree No. 4)
Article 47 of the newly developed medical devices have not been included in the classification directory, the applicant can directly apply for registration of Class III medical device products, but also based on the classification rules to determine the product category and to the State Food and Drug Administration to apply for confirmation of the category, apply for product registration or for the product record.
Directly apply for Class III medical device registration, the State Food and Drug Administration in accordance with the risk level to determine the category. Domestic medical devices to determine the second category, the State Food and Drug Administration will declare information to the applicant's location in the provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration for review and approval; domestic medical devices to determine the first category, the State Food and Drug Administration will declare information to the applicant's location in the municipal food and drug supervision and management departments for the record.
Extended reading: insurance how to buy, which is good, hand to teach you to avoid the insurance of these "pits"