New medical device registration practitioners often don’t know how to start when dealing with specific issues: how to search for regulations and technical review bases, how to execute the specific registration process, how to inquire about classification, whether clinical evaluation is required, whether clinical trials should be conducted, and what pathways are available for review consulting.
The Center for Medical Device Evaluation, NMPA (CMDE) has publicized the basic regulations, technical documents and processes. Practitioners can follow the correct approach to easily and directly solve their questions, thereby avoiding detours and increasing work efficiency.
This manual organizes related information publicized by CMDE and lists frequently asked questions and inquiry methods as a reference to industry practitioners.
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1. What are the relevant regulations for medical device registration? Where can they be inquired about and studied? |
2. How to determine the classification of a new product? |
3. What are the steps in the registration application process? Where can the requirements for each step be found? |
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4. What data is required for a registration application? |
5. Are there comprehensive technical guidance documents for inquiry during specific product development and registration? What channels can be used to seek answers to technical and regulatory questions? |
6. What are the guiding principles that can be referenced for preclinical application data on in vitro diagnostic products? |
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7. What paths are available for clinical evaluations of medical devices? Are clinical trials required? |
8. What technical documents can be referenced when conducting clinical trials? |
9. What documents can be referenced when writing clinical evaluation reports? |
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10. How to track the review progress? |
11. How long does it take to apply for the registration of a medical device product? |
12. What consultation pathways are available at CMDE? How consultation can be conducted at various stages of development and application? |
Please visit the link for related details:
https://www.cmde.org.cn/sqrzc/zxfw/ylqxzcjmzhd/index.html?type=pc&m=