NMPA (CFDA) issued Notice on Classification Procedures for Combination Device on April 17th. The new procedures will be effective on June 1, 2019:
NMPA also modified the Material Requirements for combination device classification. All materials shall be in Chinese. The materials shall include the following:
Includes product name, composition, combination method, intended use, contact with patient/contact time, product schematic, photo, etc.
Includes the main and secondary actions on combined products and components
Includes demonstration of the components that play, partially play, and do not play a major role in the combined product, the primary mode of action, the basis for the determination, and the supporting test data and literature.
To access the weblink for the Combination Device Classification System in order to submit application documents, please email info@ChinaMedDevice.com.
The Chinese company name should be included in the Chinese IFU and Label from January 1, 2019. For more information regarding new labeling requirements, please click HERE.
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ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.