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The NMPA granted Innovation Approval to three medical devices in September 2021: Dental implant surgery navigation and positioning equipment Ultrasonic diagnostic equipment for endoscope Transcatheter aortic valve and retrievable delivery
The NMPA released the “Catalog of Medical Devices and IVD Products Exempted from Clinical Trials” on September 18, 2021, which includes 1010 devices and 423 IVDs. It is an effort
The Hainan Provincial NMPA, the Hainan Health Commission, and the Haikou Customs jointly issued the “Optimizing Regulatory Services to Support the High-Quality Development of Hainan Boao Medical Tourism Pioneer Zone”
The NMPA issued the Guideline for Medical Device Clinical Trial Data Submission Requirements (draft) on September 15, 2021 for feedback. The feedback needs to be submitted by October 10. Significantly
NMPA published six guidelines in August 2021: Guideline for Safety and Effectiveness Evaluation of Medical Devices Using Nanomaterials Part 1: System Framework Guideline for Nomenclature of Nerve and Cardiovascular Surgical
NMPA granted ten special statuses in August 2021, among them are seven innovation cardio devices: Boston Scientific Corporation: Vascular Plaque Atherectomy System TriReme Medical: Paclitaxel Drug-Coated Peripheral Balloon Catheter Shandong
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega cities of Guangdong province: Guangzhou, Shenzhen,
The last time the “Medical Device Registration Administrative Measures” were completely overhauled was in 2014. The newer regulations with significant changes have been introduced focusing on expediting innovation, complete product
Guangdong government published three documents on July 19, 2021 for feedback: Key Points for Application Materials for Import and Use of Hong Kong and Macau Medical Devices by Designated Institutions
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros. These updates are presented by China Med Device LLC, your partner in Chinese market access.
The NMPA granted four fast-track statuses in July 2021, among them are two cardio devices: Innovation status Corindus: Coronary Artery Surgery Control System Shenyang Pengyue: Cardiac Cryoablation System Suzhou Hongyuan: Chromosome Abnormality
The NMPA issued the second draft “Regulations on Self-test of Medical Device Registration (Draft)” on July 23, 2021, proposing further guidance to manufacturers on how to self-test and to submit