Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in October 2021. These updates are presented by China Med Device, LLC, your partner in Chinese market access.
China Medical Device, IVD Registration and Filing Measures Effective Oct 1
The “Medical Device Registration and Filing Management Measures“ and ”In Vitro Diagnostic Reagents Registration and Filing Management Measures” have been effective since October 1, 2021.
To better implement the measures, NMPA issued the “Notice regarding Medical Device Registration and Filing Management Measures and In Vitro Diagnostic Reagents Registration and Filing Management Measures”, explaining in the details for applications accepted before January 2021, for the inspection report involved in the supplementary materials, for applications accepted before the implementation of the new mandatory standards, and for the biological test, etc. For more information please click HERE
Classification Rules for IVDs Released for the First Time
On October 29, 2021, the NMPA published the “Classification Rules for In Vitro Diagnostic Reagents”. Referencing IMDRF classification principle, the Rules list the main factors affecting the product risk as “the intended use and indications of the product, the intended use environment and the professional knowledge of the user”, “the extent to which the information of the test results affects medical diagnosis or treatment” and “impact of the test results on personal and/or public health”.
The Rules classify the IVD reagents by three categories. For our comprehensive review, pleas click HERE
Hainan Released Import Application Guidebook for Urgent Device and Drug
Hainan NMPA published “Guideline for Importation of Urgently Needed Drugs and Medical Devices in Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone” on October 15, 2021, directing importers and overseas manufacturers on how to get their unapproved but critically needed medical products into Hainan. The document species the application conditions, application materials and approval time limit, etc. For more information please click HERE
Final Guideline for Self-Test: Self Report Applicable for Class II and III Devices
NMPA finalized document “Regulations on Self-test of Medical Device Registration” today on October 22, 2021, effective from the date of announcement.
The document specifies the basic principles, requirements for self-test report, outsourcing requirements, application materials requirements and on-site inspection requirements. For more information please click HERE
NMPA Explains Self-Test Report Guideline
The NMPA issued a notice “Interpretation of Regulations on Self-test of Medical Device Registration” on October 27, 2021, asking manufacturers pay attention to the self-test capability, requirements for inspectors, requirements for test laboratories, requirements for self-test of commissioned manufacturing, requirements for internal self-test of corporate group, etc. For our comprehensive review 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, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our regulatory services include strategy, registration, 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.