Starting from May, a batch of new medical device regulations will be implemented, which are closely related to medical device production and operation enterprises. Let’s take a look!
1. The 2022 revised version of the “Measures for the Supervision and Administration of Medical Device Production” will come into effect on May 1
The “Measures for the Supervision and Administration of Medical Device Production” revised by the State Administration for Market Regulation (State Administration for Market Regulation No. 53) will come into effect on May 1. The “Measures for the Supervision and Administration of Medical Device Production” implement the latest requirements for the supervision of medical device production in the “Regulations on the Supervision and Administration of Medical Devices”, fully implement the medical device registrant and recorder system, optimize the administrative licensing process, consolidate the main responsibilities of enterprises, and further increase penalties for illegal acts. The “Measures for the Supervision and Administration of Medical Device Production” have added new penalty clauses. For those who fail to change the registration items of the medical device production license in accordance with the provisions of the “Measures”, or fail to organize and carry out coding, data uploading, maintenance and update work in accordance with the relevant national requirements for the implementation of unique identification of medical devices, the drug regulatory department shall order corrections within a time limit in accordance with their duties. If they refuse to make corrections, they will be fined not less than RMB 10,000 but not more than RMB 50,000. If the circumstances are serious, they will be fined not less than RMB 50,000 but not more than RMB 100,000.
Full text URL: https://www.nmpa.gov.cn/xxgk/fgwj/nbmgzh/20220322172616119.html
2. The “Catalogue of Prohibited Entrusted Production of Medical Devices” will come into effect on May 1, 2022
In order to strengthen the supervision of medical device production and ensure the safety and effectiveness of medical devices, in accordance with the “Regulations on the Supervision and Administration of Medical Devices”, the State Food and Drug Administration organized and revised the “Catalogue of Prohibited Entrusted Production of Medical Devices” to be effective from May 1, 2022, and the former State Food and Drug Administration’s “Notice on Issuing the Catalog of Prohibited Entrusted Production of Medical Devices” (No. 18, 2014) was abolished at the same time.
Full text URL: https://www.nmpa.gov.cn/ylqx/ylqxggtg/20220324101855146.html
3. “Good Quality Management Practices for Medical Device Clinical Trials” will be implemented on May 1
“Good Quality Management Practices for Medical Device Clinical Trials” covers the entire process of medical device clinical trials, including program design, implementation, monitoring, auditing, inspection, and data collection, recording, preservation, analysis, summary and reporting of medical device clinical trials. In my country, activities related to clinical trials of medical devices carried out for the purpose of applying for registration of medical devices (including in vitro diagnostic reagents) must comply with the Specifications.
Full text URL: https://www.nmpa.gov.cn/ylqx/ylqxggtg/20220331144903101.html
4. The “Guidelines for Preparing the Annual Self-Inspection Report of the Medical Device Quality Management System” will come into effect on May 1
The newly revised “Guidelines for Preparing Annual Self-Inspection Reports on Medical Device Quality Management Systems” by the State Food and Drug Administration will come into effect on May 1, 2022. The new guidelines refine the requirements for filling out self-inspection reports, provide more detailed and clear guidance to filers, answer their doubts in the process of filling in self-inspection reports, and consolidate the main responsibilities of enterprises. It is worth noting that in the annual quality management system operation and reporting instructions, self-examination of the establishment of the traceability system and the implementation of UDI are mentioned.
Full text URL: https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20220324100322197.html
5. The 2022 version of the “Measures for the Supervision and Administration of Medical Device Operations” will come into effect on May 1
The “Measures for the Supervision and Administration of Medical Device Operations” (Order No. 54 of the State Administration for Market Regulation), as one of the supporting regulations of the “Regulations on the Supervision and Administration of Medical Devices”, implements the latest requirements of the “Regulations on the Supervision and Administration of Medical Devices” for the operation and supervision of medical devices, embodies the latest regulatory concepts, and adheres to the four principles of classified management of medical devices, corporate responsibility, strict supervision, and traceability. When engaging in medical device business activities, the “Measures for the Supervision and Administration of Medical Device Business” not only have requirements for personnel, locations, storage conditions, etc., but also require that enterprises engaged in the business of third-category medical devices should also have a computer information management system that meets the requirements of the medical device business quality management system to ensure that the products operated are traceable. Enterprises engaged in the operation of Class I and II medical devices are encouraged to establish computer information management systems that meet the requirements of the medical device operation quality management system.
Full text URL: https://www.nmpa.gov.cn/xxgk/fgwj/nbmgzh/20220322173520166.html