NMPA News

China NMPA Announcement on the Release of 20 Medical Device Industry Standards including YY 1001-2024 “All Glass Syringe”(No. 16, 2024)

Announcement, NMPA, NMPA News, Standard / By

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 …

China NMPA Announcement on the Release of 20 Medical Device Industry Standards including YY 1001-2024 “All Glass Syringe”(No. 16, 2024) Read More »

The Accredited laboratories List for GB 9706.1-2020 and YY 9706.102-2021

Announcement, Latest News, NMPA News / By

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 »

China NMPA issued an announcement 

Announcement, NMPA, NMPA News / By

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 …

China NMPA issued an announcement  Read More »

Proton therapy system approved by China NMPA

NMPA, NMPA News / By

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 …

Proton therapy system approved by China NMPA Read More »

mark, marker, hand-516277.jpg

Transcatheter mitral valve clamp system approved for marketing

Announcement, NMPA News / By

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 »

China NMPA Update the Quality Management Specifications for Medical Device Operations

Announcement, NMPA, NMPA News / By

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 »

Cryoablation equipment and balloon cryoablation catheters approved by China NMPA

Announcement, NMPA, NMPA News / By

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 »

Notice on the classification definition of “degradable expandable hemostatic sponge” products 

Announcement, NMPA, NMPA News / By

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. …

Notice on the classification definition of “degradable expandable hemostatic sponge” products  Read More »

dyslexia, learning disorder, puzzle-3014152.jpg

Single photon emission and X-ray computed tomography imaging system approved by China NMPA

NMPA News / By

Recently, the innovative product Single Photon Emission and X-ray Computed Tomography Imaging System of Beijing Novel Medical Equipment Ltd. is approved by China NMPA. This product consists of a single photon emission computed tomography (SPECT) host (including two SPECT detectors), CT host frame, examination bed, PDU server, acquisition client workstation, SPECT acquisition server workstation, CT …

Single photon emission and X-ray computed tomography imaging system approved by China NMPA Read More »

We Help You Enter China Market

We provide hands-on solutions to you! You are free from the frustration of not knowing China culture. 

Get Appointment