Here are the latest NMPA regulatory and clinical affairs news articles in October 2020 for medical devices and IVDs pros. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
With an announcement on October 20, 2020, the NMPA reclassified 29 cancer biomarker-related reagents from Class III to Class II. The impacted reagents include Carcinoembryonic Antigen (CEA) detection reagent, Cytokeratin 19 fragment (CYFRA21-1) detection reagent, and the Squamous cell carcinoma antigen (SCC) detection reagent.
The announcement also specified the regulations applicable for IVD registration, certificate validation for already approved IVDs, and requirements for renewal. For the down-classifying list with our comments please click here.
More NMPA News for October is that they released the IMDRF (International Medical Device Regulators Forum) draft document of “Post-Market Clinical Follow-Up (PMCF) Studies”. This document was released on October 21, 2020, and was passed by IMDRF member states. It is currently seeking comments from the industry.
A PMCF study refers to research carried out after marketing authorization. It is intended to answer uncertainties relating to safety, clinical performance and/or effectiveness of a device. And clearly when its used in accordance with its approved labeling. For the full article with feedback information please click here.
The NMPA also issued “Matters Related to the Trial Implementation of Electronic Signatures for Imported Medical Device Registration Application Materials” in October. This allows the usage of submission material and an electrical signature during volume review and technical review. Paper-based signatures are still recognized.
It also published the “Pilot Use of the Electronic Registration Certificate for Medical Devices” paper. It primarily trials the electronic registration certificate from October 19, 2020, to August 31, 2021.
The two documents list requirements for manufacturers to get electronic submission material signatures and registration certificates. For the full article, please click here.
The news of the NMPA publishing the draft document titled “National Medical Device Quality Inspection Sampling Procedure” came out on October 13, 2020. The sampling requirements in the 22-page document include the record-keeping period and the location where the sampling is conducted. It will also include the parties signing off on the Result Delivery Notice, the Sampling Control System where documents are recorded, and penalties.
The document also clarifies the responsibilities of the national and provincial NMPA, NIFDC, and relevant government agencies. For the full article please click here.
The NMPA also issued news in October of “the Establishment of a Medical Robotics Standardization Agency”. This signifies the regulatory preparation for medical robotics in the near future.
The agency will be responsible for the formulation and revision of industry standards for medical robotics. They will be overseeing terminology, classification, and basic common technologies.
The first expert committee is composed of 60 members. This includes those from overseas manufacturers such as Siemens, Medtronic, Stryker, and Johnson & Johnson. For the full article please click here.
The NMPA published the “Guideline for Technical Review of Clinical Evaluation of the Same Variety of Intravascular Catheters” on October 15, 2020. It provides detailed guidance for manufacturers to go for a clinical pathway of predicate-comparison.
The NMPA issued 34 industry standards for medical devices on October 22, 2020. These standards contained indicators for orthopedic, cardiovascular, radiology, clinical chemistry, and hematology. Four general standards were also included. For the full article, please click here.
The NMPA granted priority review designation to CooperVision and Biomerieux, and gave their reasons for granting it. For more detailed information with the scenarios of priority review designation, please click here.
China Med Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical devices, IVDs, CDx and combination products in China. As a qualified NMPA legal representative 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.