1、 What are changes in medical device registration and licensing matters?

According to Article 49 of Chapter 6 of the Measures for the Administration of Medical Device Registration (Order No. 4 of the Food and Drug Administration) and the Operating Standards for Registration and Approval of Domestic Class III and Imported Medical Devices (Food and Drug Administration [2014] No. 208), the content listed in the Medical Device Registration Certificate and its attachments is the limited content for registration. For registered Class II and Class III medical devices, the content stated in the Medical Device Registration Certificate and its attachments has changed, The registrant shall apply for registration change to the original registration department.

Registration changes are divided into changes in registration items and changes in licensing items.

If there is a change in the name and address of the registrant or the name and address of the agent in the registration certificate, the registrant shall apply to the original registration department for a change in the registration items; If there is a change in the production address of domestic medical devices, the registrant shall handle the registration change after the corresponding production license change.

And the product name, model, specifications, organization and composition, scope of application, product technical requirements, production address of imported medical devices, and; Other content; If the corresponding content in the column changes, the registrant shall apply to the original registration department for a change in the licensing matters.

For any changes in the content not stated in the registration certificate and its attachments, the enterprise shall do a good job in accordance with its own quality management system requirements and ensure the continuous and effective operation of its quality management system.

2、 Can changes in medical device registration and licensing be applied for simultaneously?

According to the Announcement on Issues Related to Registration and Application of Medical Devices (including In Vitro Diagnostic Reagents) issued by the Acceptance and Reporting Center of the State Administration (No. 129), changes in registration items and changes in licensing items can be applied for separately or in combination.

For combined applications, the applicant shall fill out the "Application Form for Changes in Registration Matters of Medical Devices/In Vitro Diagnostic Reagents" and "Application Form for Changes in Registration Matters of Medical Devices/In Vitro Diagnostic Reagents" respectively, and submit them in the "; Other issues that need to be clarified; Indicate changes in merger registration items/licensing items. If the same information (including supporting documents and technical information) is used in different registration applications for the same product, only one original document can be provided along with any registration application. In other applications, the source of the original declaration information must be indicated.

After April 1, 2015, the above matters can still be applied for simultaneously, and the same requirements as the Announcement on Issues Related to Registration and Application of Medical Devices (including In Vitro Diagnostic Reagents) (No. 129) can be applied for at the same time. The relevant applications shall be processed in accordance with the procedures for applying for changes in licensing matters.

3、 What is a registered medical device?

Medical devices approved for registration refer to medical devices that are consistent with the limited content of the medical device registration certificate and its attachments, and are produced within the validity period of the medical device registration certificate.

4、 What do the relevant notarization requirements refer to?

According to the "Operation Specification for Registration and Approval of Domestic Class III and Imported Medical Devices" (Food and Drug Administration [2014] No. 208), the declaration materials for imported products, unless otherwise specified, should be signed and stamped by the applicant. Original materials; Signature; It refers to the signature of the applicant’s legal representative or person in charge, or the signing and affixing of the organizational seal, and the submission of a notarized document issued by the notary public in the applicant’s location.

Its notarization is mainly aimed at corresponding to the original materials; Signature and seal;, In order to ensure that the application for registration of imported products and the information provided are based on the applicant’s true intentions and related actions.