Apply for Shenzhen medical device production license

What information is needed to apply for a medical device business license and production license?

Process the required information：

1. Copy of business license；
2. Registration certificate of the medical device produced；
3. Product technology

Require

a copy；

1. legal representative、Copy of identity certificate of the person in charge of the company；
2. Production、Identity of quality and technical manager、Educational qualifications、Copy of professional title certificate；
3. Production management、Educational qualifications of employees in quality inspection positions、List of professional titles；
4. Documentation proving the production site，Include a copy of the property certificate or lease agreement and the leasee’s property certificate，Factory general plan，Main production workshop layout diagram。

clean

Require

workshop，Function room and person must be marked(thing)flow direction；Have a special production environment

Require

facilities should also be submitted、Copies of environmental certification documents (the clean room qualification test report should be a qualification test report issued within one year by a testing agency recognized by the provincial food and drug administration department that complies with the "Manufacturing and Management Specifications for Sterile Medical Devices" (YY0033))；

1. Catalog of main production equipment and inspection equipment；
2. Quality Manual and Procedure Documentation，The content should comply with the provisions of the Good Manufacturing Practice for Medical Devices；
3. Process flow chart，And indicate the main control items and control points，Including equipment for critical and special processes、Description of personnel and process parameter control；
4. Certificate of authorization of the person in charge；Related products：Apply for Shenzhen medical device production license

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