Summary of IVD Related Policies and Regulations in January
In January 2022, the National Health Commission, NMPA, NIFDC and other departments successively issued a number of policies, regulations, notices and announcements for the medical device industry (including IVD industry). In order to facilitate the inquiry of people in the industry and provide clear, fast and effective services, we have collected and sorted these documents in a centralized manner. The directory is as follows:
|
Release Time |
Title |
Issuing Agency |
| January 7,2022 | Notice on Publishing the Catalogue of National Standards and Reference Products of In Vitro Diagnostic Reagents for the Eleventh Registration Test |
NIFDC |
| January 7,2022 | Management Measures for Prenatal Diagnosis Technology | National Health Commission of People’s Republic of China |
| January 17,2022 | Announcement on the Release of 2 Guidelines for Registration Review of Drug-device Combination Products with the Medical Devices As Main Purpose (No.3 of 2021) |
NMPA |
| January 17,2022 | Notice on the Approval of Registration of 211 Medical Device Product(No.4 of 2021） |
NMPA |
| January 17,2022 | Notice on Issuing Technical Specification for 20 in 1 Mixed Sampling Nucleic Acid Inspection of Covid 19 | The Medical Treatment Team under the Joint COVID-19 Prevention and Control Mechanism of the State Council |
| January 18,2022 | Notice on Issuing Work Progeramme for Screening Cervical Cancer and Breast Cancer | National Health Commission of People’s Republic of China |
| January 19,2022 | Notice on Issuing Two Technical Guiding Principle for the Registration and Review of Biosafety Cabinet(No.108 of 2021) |
NMPA |
| January 21,2022 | Notice on Printing and Distributing the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) | National Health Commission of People’s Republic of China |
| January 24,2022 | Notice on Soliciting the Collaborative Calibration Unit of the National Reference Material for the L1 Typing of the Second Generation Human Papillomavirus |
NIFDC |
| January 27,2022 | Report of the State Drug Administration on the Registration of NMPA in 2021 |
NMPA |
| January 27,2022 | Notice on Soliciting 7 Items of Information about IVD Reagents Manufacturer |
NMPA |
|
CMDE |
||
| January 29,2022 | Notice on Further Improving Demonstration and Promotion of Unique Identification of Medical Devices |
NMPA |
If you need help on medical device registration in China, please feel free to contact us (info@inspirativemed.com) for any questions.
