NMPA (CFDA) issued Notice on Classification Procedures for Combination Device on April 17th. The new procedures will be effective on June 1, 2019:
- A specialized department, NMPA Standardization Management Center (http://app.nifdc.org.cn/biaogzx/login.do?formAction=login&yxzh=yxzh), will take over NMPA Administration Center for combination device classification.
- Applicants shall submit application documents to Standardization Management Center through Combination Device Classification System.
- The Center will reply to the applicants with a Classification Opinion within 20 days; the Technical Opinions from an Expert Committee may be needed.
- If supplementary materials are needed, applicants shall submit the supplements to the Center within 30 days.
- The Center will announce the Classification Results periodically.
Material Requirements
NMPA also modified the Material Requirements for combination device classification. All materials shall be in Chinese. The materials shall include the following:
- Product Description
Includes product name, composition, combination method, intended use, contact with patient/contact time, product schematic, photo, etc.
- Mechanism
Includes the main and secondary actions on combined products and components
- Instructions for Use or User ‘s Manual
- Source of each component
- Applicant’s Opinion and Supporting Documents
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.
- Home-country-approval (if applicable)
- Other supporting documents
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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About ChinaMed Device, LLC
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.