The Record Procedure for Imported Medical Devices of Class I in China

Foreign manufactures who want to sell their products in China are required to obtain pre-market approval from the Chinese Food and Drug Administration (CFDA). The approval of Class I medical device is known as the Medical Device Record, of which the procedure is different from Registration of Class II/III medical devices.
The operational processes for Medical Device Record are showed as following five steps:

Step 1.Classfication

Determine the classification of your product based on Chinese regulations and make sure that your product is managed as Class I medical device in China. How to determine the classfication, please click here.

Step 2. Designation of China Agent

Designate an agent who is registered in China and will coordinate and control your CFDA registration, as well as undertake the corresponding legal liability.

Step 3. Dossier Preparation

Prepare relevant record documents. As following:

1. Supporting Doc. Copy of Registration Certificate Copy of Business License Copy of GMP/ ISO13485/ Manufacturing License	1. Copies shall be signed by your legal person and sealed 2. Copies shall be notarized by your local law office and indicate that they are consistent with the originals 3. Copies shall be translated in Chinese And the translations must be sealed and signed by your China Agent
2.Technical Doc. Risk analysis report Technical requirements Self-test report Clinical evaluation materials Manufacturing information POA of China agent Declaration of Conformity	1. Documents shall be translated in Chinese 2. The translations shall be signed by your legal person and sealed 3. Above resulting docs shall be notarized by your loal law office and indicate that the seal and signature are authentic 4. The copies of the translations shall be sealed and signed by your China Agent Note: Foreign self-test reports and foreign clinical data of Class I medical devices are generally accepted by CFDA
3.Instruction & Label of the minimum marketing unit: Chinese instruction and label Samples Original instruction and label and their Chinese versions	1. Files shall be signed by your legal person and sealed 2. Files shall be notarized by your local law office and indicate that the seal and signature are authentic. 3. The copies of the files must be sealed and signed by your China Agent.
4. Files From Agent Business License Copyof agent Letter of commitment of agent	1. The files are sealed and signed by your China Agent

Step 4 Fill Application Form on line

Login on line Registration Management Information System. Fill your information and submit, the system will automatically generate the application form for you. Print the application form. The application form must be signed and sealed by your China Agent.
If you want know more about information of Registration Management Information System. Please click here.

Step 5 Dossier Submission

Please be well noted that you shall post the paper submission to CFDA or do the live submission in CFDA within 30 days after you submit the on line application form. Otherwise, you have to re-fill and submit the application form online again.

You will receive a Record certificate when your application successfully passes CFDA review. And afterwards you don’t need to renew your certificate as long as the classification of your product is not changed from Class I to Class II/III.

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