On February 7, 2024, China CMDE.NMPA issued the draft guidance “Guideline for registration review of estrogen receptor and progesterone receptor antibody reagents and detection kits (2023 revised version)”.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 »
Document Number: No. 150, 2023 On December 15, 2023, NMPA released an announcement regarding the trial implementation of emergency use management regulations for medical devices. These regulations were formulated by NMPA to address major public health emergencies and other serious crises, providing guidance on the emergency use of medical devices. In the event of significant …
Document Number：No. 3, 2024 Date Issued: January 15, 2024 To further guide the standardized development of real-world research on medical devices, CMDE has formulated this guideline. It serves as a guiding document for registration applicants and technical reviewers. This guideline applies to real-world research on medical devices but is not applicable to real-world research on IVD( in vitro diagnostics）. …
Release date: 2023-11-30 Recently, the China NMPA approved the innovative product registration application for the “Transcatheter Mitral Valve Clamp System” of Hangzhou Dejin Medical Technology Co., Ltd. This product consists of two components: the guiding sheath and the mitral valve clamp system. Among them, the mitral valve clamp system includes a mitral valve clamp and …
Transcatheter mitral valve clamp system approved for marketing Read More »
Release date: 2023-12-07 In order to strengthen the quality management of medical device operations, standardize medical device operations, promote the development of industry standards, and ensure the safety and effectiveness of medical devices used by the public, in accordance with relevant laws and regulations, the China NMPA has revised the “Quality Management Specifications for Medical …
China NMPA Update the Quality Management Specifications for Medical Device Operations Read More »
Release date: 2023-12-05 Recently, the China NMPA approved the registration application for innovative products “cryoablation equipment” and “balloon cryoablation catheter” produced by Kangfeng Biotechnology (Shanghai) Co., Ltd. “Cryogenic ablation equipment” consists of a freezing device, a vacuum system, a low-temperature fluid delivery circuit and a control system. The “balloon cryoablation catheter” consists of equipment connection …
Cryoablation equipment and balloon cryoablation catheters approved by China NMPA Read More »
