The New Rules for the Registration of Medical Devices Formally Implements.

The new regulations on the requirements of medical device registration and declaration materials the Announcement on Publishing the Requirements of Medical Device Registration and Declaration Materials and the Format of Approval Supporting Documents (No. 121 of 2021) has been officially implemented on January 1, 2022. The new regulations on the requirements of registration and declaration materials  has adjusted the content and form of medical device registration and declaration materials, the enterprise shall complete the preparation or update of registration application materials according to the new requirements.

The new registration application data requirements are formulated by combining the document structure of eRPs, order No. 43 and IMDRF TOC, and integrating the requirements of medical device supervision and administration regulations, medical device registration management measures and the list of basic principles of safety and performance of medical devices.

1.Quality management system document is required: after the new requirements for quality management system documents are implemented, the registration applicant shall submit the quality system documents together with the product registration. Quality system documents include original manufacturing information, system verification application, quality manual and procedure documents.

2.Changes in the content of clinical evaluation: according to the definition of the new regulations in the regulations on the supervision and administration of medical devices, the concept of clinical evaluation has changed. Clinical evaluation includes comparison with the same variety and clinical trial. The products exempted from clinical trial are changed to products exempted from clinical evaluation. Therefore, the comparative data of products exempted from clinical evaluation have also been moved to other data directories in non clinical studies. Whether it is the same variety comparison or clinical trial, when submitting the clinical evaluation report, a clinical evaluation report should be formed on the product description, R & D background, clinical evaluation scope, clinical evaluation approach, clinical evaluation evidence, etc. Especially for the clinical trial mode, the clinical trial report and ethical approval documents are only submitted as attachments. In addition, it should be noted that the clinical trial approach adds the submission requirements of clinical trial data (original database, analysis database, explanatory documents and program code).

3.Data on non_clinical literature research has been newly increased: new non clinical literature research: if the declared product has published non clinical research literature (such as cadaveric research, biomechanical research, etc.), the literature / bibliography list shall be provided, and copies of relevant contents shall be provided.. New non clinical literature research: if the declared product has published non clinical research literature (such as cadaveric research, biomechanical research, etc.), the literature / bibliography list shall be provided, and copies of relevant contents shall be provided.: if the declared product has published non clinical research literature (such as cadaveric research, biomechanical research, etc.), the literature / bibliography list shall be provided, and copies of relevant contents shall be provided.

4.Overview of overseas listing history of new products: if the product has listing history in other countries / regions, it shall describe its listing time, sales situation and differences in listing between different countries / regions (if any); In addition, post marketing adverse events and recall information, sales, adverse events and recall rate shall be provided.

5.Summary of communication history with regulators before new declaration: if the product has a history of meeting communication or previous declaration before listing, the past problems, solutions, solutions, meeting materials and minutes should be collected and submitted. If there is no previous communication history, a declaration of inapplicability should be provided.

In order to help overseas manufacturers understand more China registration requirements on medical device，please reach out to us via info@inspirativemed.com