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Medical Device Registration

1. Registration Application and Evaluation Process

2.Medical device registration service process

Medical Device Record-Filing

Norsda is ready to provide the following service in accordance with regulations of Class 1 medical device issued by NMPA.

1. To draft product technical specifications, instruction and label；

2. To provide Product Property Testing Service;

3. To draft Product Clinical Appraisal;

4. To draft Product Risk Analysis;

5. To draft product technical procedure;

6. To draft Quality Management Brochure and Procedure documents.

7. To Follow up with record-filing process