Starting from May, these new regulations for medical devices will be implemented!

New national regulations

01 . Interim Measures for the Management of Medical Security Fund Flight Inspection

The Interim Measures for the Management of Medical Security Fund Flight Inspection, issued by the National Medical Security Administration, will take effect on May 1, 2023.

The Measures specifies that in one of the following situations, the medical security administrative department can initiate flight inspections, including:

Arranged by the annual work plan; The information provided reflects that there may be major security risks in the medical security fund;

Intelligent medical security monitoring or big data screening indicate that there may be major security risks in the medical security fund;

Exposure by the news media, causing major social impact; Other circumstances requiring flight inspection.
There is no doubt that the formal introduction of this document is a document of great historical significance in the field of medical insurance fund supervision and will provide an important reference standard for the standardization of flight inspection.

02．Circular of the NMPA on the Implementation of GB 9706.1-2020 and Supporting Parallel Standards and Special Standards (No. 14, 2023)

The Announcement pointed out that GB 9706.1-2020 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance has been released on April 9, 2020, and implemented since May 1, 2023. Its supporting parallel standards have been released, and special standards are being released one after another.

This document，from the four aspects， including strict implementation of the relevant standards requirements, registration and archival standards implementation requirements, inspection standards implementation requirements, strengthening supervision and management of standards implementation , put forward clear requirements for the product registrant and record person, technical review, inspection, supervision and management and other links of the work.

New local regulations

03 Implementation Rules for the Supervision and Management Measures of Medical Device Production in Beijing

The Implementation Rules of Beijing Medical Device Production Supervision and Administration Measures issued by Beijing MPA came into force on May 1, 2023.

04 Regulations on the Supervision and Management of Clinical Urgent Imported Drugs and Medical Devices in the International Medical Tourism Pilot Zone of Hainan Free Trade Port

Regulations on the Supervision and Management of Clinical Urgent Imported Drugs and Medical Devices in the International Medical Tourism Pilot Zone of Hainan Free Trade Port issued by Hainan Provincial People’s Government  came into force on May 1, 2023.

The Regulations put forward 36 measures, further clarifying the specific management requirements on the application, circulation, use and supervision of medical devices imported from Leccheng Pilot Zone that have been approved and listed overseas, have not been approved and registered in China and cannot be replaced by domestic listed varieties (excluding vaccines) or have been approved and listed overseas and have not yet been registered in China.

05 Announcement of Hunan MPA on the Implementation of Electronic Certificates for Administrative Approval of some Drugs and medical Devices such as Internet Drug ,Medical Device Information Service License

Starting from May 1, 2023, enterprises that have applied for Internet drug information service according to the Administrative Measures for Internet Drug Information Service and have been approved to issue or change the application will begin to issue e-certificates of Internet drug information service qualification. Medical treatment units that have submitted applications for the use of radioactive drugs according to the Measures for the Administration of Radioactive Drugs and have been approved to issue or change them shall begin to issue electronic licenses for the use of radioactive drugs. Enterprises that apply for online trading services of medical devices according to the Measures for Supervision and Administration of Online Sales of Medical Devices and have been approved for approval and change shall begin to issue electronic record certificates of third-party platforms for online trading services of medical devices.

The paper certificates issued before are still valid within the validity period.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Source：Device Market

Translated & edited by Bradyknows