Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros for November 2021. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
How to Submit Clinical Trial Data? New Guidance Reveals
The NMPA published the “Medical Device Clinical Trial Data Submission Guideline” and “In Vitro Diagnostic Reagent Clinical Trial Data Submission Guideline” on November 25, 2021, finalizing the draft issued in mid-September. They are to direct manufacturers on how to collect, organize, analyze and submit clinical trial data, and improve the quality of clinical trial implementation and management.
Significantly referring to the Clinical Data Interchange Standards Consortium (CDISC) standards, the guidelines detail requirements on the original database, analysis database, explanatory documents and program codes. For more details please click HERE
Which 22 Devices Not Allowed for Contract Manufacturing?
The NMPA published the “Catalog of Medical Devices Prohibiting of Entrusted Production” on November 17, 2021, providing the scope of 22 devices which are not allowed for contract manufacturing. For the list of devices please click HERE
NMPA to Re-Classify 31 Medical Devices
The NMPA issued the “Adjustment of Med Device Classifications Catalog (Draft)” on November 12, 2021, in a proposal to readjust classification, intended use and example names for 31 medical devices. For the list of devices please click HERE
Working Process and Timeline Explained for Imported Device Registration
The NMPA published the “Registration Review Guideline for Domestic Class III and Imported Medical Devices”, specifying working processes and timelines of registration application, clinical application and change application. The document also stipulates the responsibilities of NMPA, center of medical device evaluation (CMDE) and administration center. For more information with keys issues in the guideline please click HERE
New Guidelines Stipulate Medical Device Animal Study
The NMPA published the revised version of “Medical Device Animal Study Guideline Part 1: Decision-making Principles” and “Medical Device Animal Study Guideline Part II: Test Design and Quality Assurance”. Animal study is to evaluate the safety and efficacy of medical devices. In the design process, after implementing risk reduction control measures, the effectiveness of risk control measures needs to be verified and validated.
For the key Issues in the guidelines, including necessity to carry out an animal study, the difference between animal study and biological evaluation research, and the study design, pleas click HERE
Four Devices Receive Innovation Approvals in One Week
The NMPA granted Innovation Approval to four medical devices in the first week of November 2021 (click HERE for the list). Since the pathway established in 2014, 130 innovative devices have been approved.
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.