Q&A – Medical Device/IVD/CDx QMS/PMS

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Do all the documents for NMPA Overseas Inspection need to be in Chinese?


Yes. According to “Administrative Regulations of Drug and Medical Device Overseas Inspection” issued in December 28, 2018, “the working language shall be in Chinese; documents such as application material and Corrective Outcome shall be in Chinese; English-Chinese translator shall be in place during the inspection.”

What documents should be submitted after receiving Notice of Overseas Inspection?


According to “Administrative Regulations of Drug and Medical Device Overseas Inspection” issued in December 28, 2018, “Manufacturers need to, within 20 business days after receiving the notice, submit the Medical Device Overseas Inspection Basic Information Form and authorization letter to the inspection center; and, within 40 business days after receiving the notice, submit site master file and other required information according to Content of Site Master File.”

For Overseas Inspection, which documents should be included in the Content of Site Master File?


According to “Administrative Regulations of Drug and Medical Device Overseas Inspection” issued in December 28, 2018, Content of Site Master File shall include documents on following:

1. Manufacturer Overall Information
2. Quality Management System
3. Supplier(s) and Contractor(s) Management
4. Personnel
5. Manufacturing Facility
6. Equipment
7. Document Control
8. Manufacturing Process
9. Material and Storage
10. Quality Control
11. Sales, Distribution, Defect and Recall
12. Internal Audit
13. R&D
14. Documents Authenticity Statement

What the interval is for on-site surveillance audits after approval?


There is no certain timeline for the audits. The high-risk, implantable or sterile devices do get higher chances to be picked for audits. We did the training for NMPA (CFDA) inspectors with U.S GMP personnel and know them well.