In February 2024, China NMPA approved a total of 193 registered medical device products. Among them, there are 148 domestic Class III medical device products, 21 imported Class III medical device products, 22 imported Class II medical device products, and 2 Hong Kong, Macao and Taiwan medical device products.
In January 2024, China NMPA approved a total of 321 registered medical device products. Among them, there are 247 domestic Class III medical device products, 41 imported Class III medical device products, and 33 imported Class II medical device products.
CMDE has announced the following schedule for Pre-Submission Communication: Date CMDE Department March 1, 2024 Dept 1/2 of Technical Review Dept 1 of Clinical and Biostatistics March 8, 2024 Dept 3/4 /5 of Technical Review March 15, 2024 Dept 6 of Technical Review Dept 2 of Clinical and Biostatistics General Operation Dept March 22, …
As of January 31, 2024，the medical device registration and licensing information in China provinces is as follows: No. Provinces Domestic medical device products Medical Device Manufacturing Medical device Distribution On-Line Sales Filing Third-Party Platform for Medical Device Sales Registration Registration License（pcs） Filing（pcs） Permit（pcs） Filing（pcs） Permit （pcs） Filing（pcs） 1 Beijing 8124 4087 770 671 2883 43808 …
Medical Device Registration and Licensing Information in China Province Read More »
On February 7, 2024, China NMPA released 20 Medical Device Industry Standards including YY 1001-2024 “All Glass Syringe”. The following is the detail information: No. Standard No. Title Status Scope of application Effective Date 1 YY 1001—2024 All glass syringes Revised This document specifies the structural type, materials, requirements, marking, packaging, transportation and storage of …
On February 7, 2024, China CMDE.NMPA issued the draft guidance “Guideline for registration review of estrogen receptor and progesterone receptor antibody reagents and detection kits (2023 revised version)”. CMDE called for the public comments on the draft guideline before February 29, 2024.
On February 5, 2024, CMDE released the Technical Review Guidance for Laser Equipment for Myopia and Amblyopia (2024 No. 6). Login for original document.
The electronic Regulated Product Submission (eRPS) was implemented starting from June 24, 2019. However, NMPA has announced its decision of excluding the registration submission from the eRPS system in order to make it more convenient to the applicants. Meanwhile, NMPA issued the electronics documents structure to help the applicants to prepare the submission dossier. …
Notice on Adjusting the Business Scope of eRPS (2024 No. 7) Read More »
Till January 8,2024, China National Institutes of Food and Drug Control has issued 1000+ CMA Certificates related to 75 PCS of newly released GB 9706 series and YY 9706 Series Standards. The Accredited laboratories List for GB 9706.1-2020 and YY 9706.102-2021 are released at the same time. This is to help the manufacturers to conform …
The Accredited laboratories List for GB 9706.1-2020 and YY 9706.102-2021 Read More »
Document Number: No. 1 of 2024 On January 22, 2024, the China CMDE announced that seven innovative medical devices, including the cardiac pulse electric field ablation system of Insight Lifetech Co., Ltd., and the interventional ventricular assist system of Xinqing Medical (Suzhou) Co., Ltd., have entered the special review process. Special Instruction: Entry into the …
Batch of Innovative Medical Devices Undergoes Special Review Process Read More »
