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Registration of China medical device products

Time:2022/7/13 Posted:Deeplight Technology Co.,Ltd

 

1. What information is required for the filing and registration of medical device products in China:


1) Product risk analysis data;

 

2) Product technical requirements;

 

3) Product inspection report;

 

4) Clinical evaluation data;

 

5) Product instructions and label samples;

 

6) Quality management system documents related to product development and production;

 

7) Other information required to prove the safety and effectiveness of the product.

 

The product inspection report shall meet the requirements of the National Medical Products Administration, which can be a self-inspection report issued by the applicant or filing person for medical device registration, or an inspection report issued by a qualified medical device inspection agency.

 

 

2. The registration and filing of medical device products shall be subject to clinical evaluation; however, one of the following conditions may be exempted from clinical evaluation:

 

1) The working mechanism is clear, the design is finalized, the production process is mature, and the clinical application of the same variety of medical devices that have been on the market for many years has no record of serious adverse events, and does not change the routine use.

 

2) Others that can prove that the medical device is safe and effective through non-clinical evaluation. The National Medical Products Administration should develop guidelines for clinical evaluation of medical devices.

 

The clinical evaluation of medical devices can be based on the product characteristics, clinical risks, existing clinical data and other situations, through clinical trials, or through the analysis and evaluation of the clinical literature and clinical data of the same type of medical devices, to prove the safety and effectiveness of medical devices.

 

According to the regulations of the National Medical Products Administration, when conducting clinical evaluation of medical devices, if the existing clinical literature and clinical data are insufficient to confirm the safety and effectiveness of the products, clinical trials should be carried out.

 

Clinical trials of Class III medical devices with relatively high risks to the human body shall be approved by the National Medical Products Administration.

 

When the National Medical Products Administration approves clinical trials, it shall conduct a comprehensive analysis of the equipment, professionals and other conditions of institutions undertaking clinical trials of medical devices, the degree of risk of the medical device, the implementation of clinical trials, and the comparison of clinical benefits and risks,and make a decision and notify the clinical trial sponsor within 60 working days from the date of acceptance of the application. Failure to notify within the time limit shall be deemed consent.

 

If the clinical trial is approved, the local provincial drug administration and the competent health department of the clinical trial institution shall be notified. The catalog of Class III medical devices with higher risks to humans in clinical trials is formulated, adjusted and published by the National Medical Products Administration.

 

The above is a brief introduction to medical device registration and filing, Deeplight has completed relevant testing and certification for medical device products from many countries to enter the Chinese market.


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