NMPA Roundup – Medical Devices December 2021

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Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in December 2021. These updates are presented by China Med Device, LLC, your partner in Chinese market access.

Policies

Final Guideline for IVD Overseas Clinical Data Acceptance Issued

NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostics” on December 3, 2021. The differences between domestic and overseas clinical trials should be analyzed first, the guideline says. The document gives examples to demonstrate how to deal with each difference. It also lists detailed requirements for IVD overseas clinical data acceptance. For our comprehensive review please click HERE

How to Interact with NMPA for Your Innovative & Priority Device?

NMPA released the “Communication Standards for Innovation Approval and Priority Review” on December 1, effective from the date of publication. The standards are to direct manufacturers on what to expect for NMPA reviewers’ responses. It lists timelines for communication steps and discussion items in the meeting. For more information please click HERE

Clinical Trial Implied Permission for Class III Devices

The new “Regulation for Medical Device Administration and Supervision”, Order 739, effective since June 1, 2021, allows the implied permission for class III devices conducting clinical trial. It states that, once the receipt of Clinical Trial Application is received, the sponsor can initiate clinical trials after waiting 60 days, in the absence of a rejection or deficiency notice. CMDE (NMPA Center of Medical Device Evaluation) website lists Class III devices went through implied permission. For the complete list click HERE

Guidelines & Standards

Standards Published for Devices Containing Nanomaterial

NMPA published the “Evaluation of the Safety and Effectiveness of Medical Devices Containing Nanomaterials Part I: Framework”, directing manufacturers on key issues of nanomaterials’ registration.

The standard addresses the issues such as the risk evaluation, safety evaluation and physical and chemical characterization, and biological evaluation. For more information please click HERE

19 Standards Issued in One Day

NMPA released 19 industry standards on December 10, 2021, with indications ranging from cardiovascular, plastic surgery, oncology, clinical chemistry and immunology, etc. The standards revisions are to provide manufacturers on NMPA new regulatory thinking of type testing and registration submission. For the complete list, please click HERE

34 Guidelines Released in December

NMPA published 34 guidelines in December 2021, involving provisions on clinical trials, same-variety comparison, and regulatory review for a wide range of indications. Significantly referred to many FDA guidance, these documents are aimed to make NMPA regulations more consistent with international standards. For the complete list, please click HERE

About China Med Device, LLC 

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. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.

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