Here’s the June 2020 China NMPA 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.
“Regulations on the Management of Imported Medical Devices Urgently Needed in the Hainan Pioneer Zone” was published by Hainan government on June 2, 2020. It sets forth the qualification of user facilities (hospitals) and the process of application evaluation, and clarifies the requirements for user facilities, overseas manufacturers, distributors, and bonded warehouses.
Over the last two years, 100 medical devices and drugs for urgent clinical use have been imported to Hainan, according to press release from Hainan government on June 9, 2020.
To see how foreign-approved devices without predicates marketed in China are imported to Hainan, please click HERE.
NMPA is Revising Clinical Trial Approval Catalog
NMPA published the draft version of Catalog of Class III Medical Devices Requiring Clinical Trial Approval on June 25, 2020. Feedbacks need to be submitted by July 31, 2020. The current proposed category lists six class III devices that must obtain NMPA clinical trial approval before conducting research. See full article HERE.
Feedback Needed for CDx Guideline
NMPA is collecting CDx manufacturer’s information on the upcoming “Technical Review Guideline of Clinical Trial for Co-development of CDx Reagents and Anti-tumor Drugs”. The notice is not only intended for the manufactures with the CDx reagents already approved by NMPA, but also for the companies which plan to enter the CDx space in China. See full article HERE.
Four Orthopedic Guidelines Issued in One Day
NMPA published 15 guidelines in June to guide manufacturers for local type testing and regulatory approval. Among them, four orthopedic guidelines, including two 3D printing-related, were issued in one day. See full article HERE.
Edwards Lifesciences’ Transcatheter Aortic Valve System Obtained Innovation Approval
NMPA granted Innovation Approval to Edwards Lifesciences’ Transcatheter Aortic Valve System on June 8. It is the 14th device obtained such approval in 2020. To see what NMPA stated in the approval notice and how Edwards Lifesciences went through overseas clinical data pathway, please click HERE.
In One Day, Two AI Diagnostic Software Go into Fast-Track Channel
NMPA granted fast-track channel status to two domestic AI-infused software on June 29, 2020. To see the two categories of AI devices and guidelines on how to get them approved, please click HERE.
China Med Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.