Priority Legislative Tasks for FY2024
On April 8, the SAMR(State Administration for Market Regulation) website news, the SAMR of the 2024 annual key legislative tasks to make deployment, scientific and systematic planning of legislative work. A total of 20 projects, such as the Law of the People’s Republic of China on the Management of Medical Devices, have been listed as key legislative projects:
| No. | Name of Laws & Regulations |
| 1 | Product Quality Law of the People’s Republic of China |
| 2 | Medical Device Management Law of the People’s Republic of China |
| 3 | Provisions of the State Council on the Implementation of the Administrative System for the Registration of Registered Capital under the Company Law of the People’s Republic of China |
| 4 | Provisions of the State Council Regulating the Compulsory Cancellation of Companies |
| 5 | Anti-Distribution Ordinance |
| 6 | Regulations on Safety Supervision of Special Equipment |
| 7 | Regulations of the People’s Republic of China on Certification and Accreditation |
| 8 | Regulations on the Protection of Varieties of Chinese Medicines |
| 9 | Measures for the Administration of Registration of Individual Entrepreneurs |
| 10 | Interim Measures for Sample Inspection of Enterprise Public Information |
| 11 | Market Supervision and Management of Serious Violations of Law and Failure to Credit List Management Measures |
| 12 | Food production and management enterprises to implement the main responsibility for food safety supervision and management regulations |
| 13 | Supervision and management measures for commissioned production of food |
| 14 | Food labeling supervision and management measures |
| 15 | Supervision and management regulations on the implementation of the main responsibility for food safety in centralized food units |
| 16 | Supervision and management of legal measurement and verification institutions |
| 17 | Management of specialized measuring stations |
| 18 | Management of standardized substances |
| 19 | Management of the adoption of international standards |
| 20 | Supervision and management of inspection and testing organizations |
The Plan for Preparation of Guidelines for the Review of Medical Device Registrations in FY2024
The Plan for Preparation of Guidelines for the Review of Medical Device Registrations in FY2024 mentions that 49 guidelines for the review of Class III medical device registrations will be formulated and 60 guidelines for the review of Class II medical device registrations will be revised in FY2024. Contact us for more details.
2024 National Medical Device Sampling Product Inspection Plan
March 19 the State Drug Administration website released “State Drug Administration Comprehensive Department on the issuance of 2024 national medical device sampling product testing program notice” which mentioned:
The State Drug Administration is now “2024 National Medical Device Sampling Product Inspection Program” issued to the provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps and Drug Administration, the China Food and Drug Certification and Research Institute, the relevant inspection agency. And requires the above units should be in accordance with the inspection program to organize the relevant inspection agency in accordance with the mandatory standards for medical devices, registered or filed product technical requirements to carry out the inspection work.
