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:2023-12-28 Recently, the innovative product Proton Therapy System of Varian Medical Systems Inc. is approved by China NMPA. This product is composed of proton accelerator subsystem and treatment subsystem. The proton accelerator subsystem consists of 3 major components: main proton accelerator system, energy selection system and beam transport system. The treatment subsystem contains 3 …
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 »
Release date: 2023.12.06 In order to further clarify the management attributes and categories of “degradable expandable hemostatic sponge” products, the China NMPA notice as follows: 1. “degradable expanding hemostatic sponge” products are polyether-type polyurethane sponges, which are composed of (DL-lactide-co-ε-caprolactone)-urethane copolymer and are disposable. Products have been sterilized by irradiation and should be sterile. …
On October 23, 2023，NMPA announcement No. 135 [2023], NMPA has decided abolished YY 0569-2011 “Class II Biological Safety Cabinet” and YY/T 0687-2008 “Surgical Instruments – Non-cutting Articulated Instruments – General Technical Conditions” two medical device industry standards.
This article is focus on how to deal with the renewal of existing registrations, the adoption of new and recommended standards, and the modification of product instructions and labels. 1. Renewal of Existing Registrations: If medical devices applying for registration renewal can’t meet the new mandatory standards, the renewal will not be granted. Existing registrations …
NMPA published its mandatory YY standards and recommended YY standards modification plan on May 23, 2023 (Refer to Notification 17-2023). Below are some of the standards: Cardiopulmonary diversion system：Disposable arteriovenous cannula (YY 0948-2015, ISO 18193:2021) Single-use hollow fiber blood filter ( YY 0465-2019, ISO 8637-3:2018 ) Medical Electrical Equipment Part 2-87: Specific requirements for basic …
