MEDICAL DEVICE REGULATION IN CHINA

Medical devices are regulated by the National Medical Products Administration (NMPA), formally China Food & Drug Administration (CFDA) whose objective is to strengthen the supervision and administration of medical devices, ensuring their safety and effectiveness, protecting human health, and life safety.

The regulatory processes and evaluations by NMPA are challenging and having a consultant that can communicate well with the NMPA and the clinical trial support team will definitely help speed up the approval process.

MEDICAL DEVICE REGISTRATION AND APPROVAL IN CHINA

Medical devices are classified into 3 categories namely class I, II, III (I being the lowest risk and III being the highest risk).

There will be communication with the relevant Testing Laboratory in seeking on the product type testing to be conducted or exempted based on equivalency of existing testing done by the manufacturer.

Apart from the submission of required documentation, some product category may also require a local clinical trial to be conducted and approved by the NMPA before the medical device product gets approval in China.

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The ARQon local team in China will assist in the product registration and technical requirement documentation preparation. This also includes any clinical trial if required, the planning, approval, and conduct of the trial in China.

INNOVATION DEVICE PATHWAY

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The NMPA has implemented the Innovation Pathway to encourage innovations of the medical device industry. It provides supported application process for fast regulatory clearance on qualified medical devices.

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In order to qualify for the innovation pathway program, manufacturers must have solid traceable research data on Class II/Class III medical devices and valid Chinese Patent. This application must be submitted to NMPA within 5 years of patent publication, and its registration submission must be received within 5 years of NMPA'S confirmation of approval for this registration route.

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Documents needed:

1. Applicant qualify identification

2. IP identification

3. The summary documents of research and development process and result

4. Technical document for product
   the intended use
   the working principle / mechanism of action
   the main technical specification and the basis; main raw material; main manufacture process chart, and the testing method of main technical specification

5. the identification document for product innovation
   the IP report
   A summary of academic papers, monographs, and documents published in the core journals that fully demonstrate the clinical value of the product.
   The analysis and comparison of similar products (if any)
   The innovation parts and the clinical value of the product

6. The safety and risk management report of product

7. The operation manual of product (change be sample)

8. Others

9. For foreign applicant, there should be an Authorised Representative (AR) in China.
   The letter of commitment
   The letter of authorization
   The qualify identification documents of AR

10. The statement of authenticity