Medical device registration management regulations
Publisher:信然宜诚Release Time:2016-12-20Views:4518


First, what is the change of medical device registration and licensing matters change?

On the basis of "medical device registration" (food and Drug Administration Decree No. fourth) sixth chapters forty-ninth and third "domestic and imported medical device registration and approval of operating norms" (SFDA tube [2014]208), "medical device registration certificate" the contents and its annex limited content for registration, registered second class, third class medical devices, change occurs in the contents of certificate of registration of medical devices and accessories as the registrant shall apply for registration, change to the original registration department.

The change of registration shall be divided into the change of registered items and the change of the licensing matters.

The registration certificate of registration in the name and domicile of the agent, the name and domicile of the change, the registrant shall apply to the original registration authority for registration of change; domestic medical device production address changes, the registrant shall register with the change in the corresponding production license after the change.

The registration certificate and its accessories specified in the name, type, specification, composition, mechanism and applicable scope, technical requirements, change the imported medical instruments production addresses and other content "column in the corresponding content, the registrant shall apply for a change to the original registration department.

In the absence of a change in the contents of the registration certificate and its attachments, the enterprise shall, in accordance with the requirements of its own quality management system, do a good job in the relevant work and ensure the continuous and effective operation of the quality management system.

Two, medical device registration matters change and licensing matters can apply at the same time?

According to the General Administration of accepting and reporting center "on medical devices (including in vitro diagnostic reagents) registration related issues notice" (No. 129th), registration of alteration and licensing matters can apply for a change, can also be combined with application.

With the application, the applicant shall fill in "medical devices and in vitro diagnostic reagents for the registered items change request form" and "medical devices and in vitro diagnostic reagents registration change application form", and "other explanations" indicated in the merge registration matters / license change matters. Different applications for registration of the same product in the same data (such as the use of proof documents and technical information), can only provide a copy of the original data with any application for registration of declaration, the declaration must indicate the original source data of other applications.

In April 1, 2015, these matters can still apply at the same time, at the same time "on the application and medical devices (including in vitro diagnostic reagents) registration related issues notice" (No. 129th) requirements. The application shall be handled in accordance with the procedures for the application of the change of the license.

Three. What is the registered medical device?

A medical instrument that is allowed to be registered is a medical device which is identical with the medical device registration certificate and the accessory, and is manufactured in the period of validity of the medical device registration certificate.

Four, what is the relevant notary requirements?

On the basis of "third kinds of imported medical instruments and in the registration and approval of operating norms" (SFDA tube [2014]208) clear, imported products to declare, if no special instructions, the original data should be borne by the applicant signature. The original "signature" refers to the applicant: the legal representative or the signature of the person in charge, or the signature and stamp of the organization shall submit a notarized copy of the seal, and issued by the applicant of the local notary office.

The notary is mainly for the original data corresponding to "signature", in order to ensure that imported product registration application and the information provided by the applicant is the true will of itself, the behavior of real.