Date
Tuesday, January 11, 2022, 8:00-9:00 AM Pacific Time (US and Canada)
Summary
Since the implementation of Order 739 Regulations on Supervision and Administration of Medical Devices in June 2021, China continues to enhance post-market surveillance on medical devices from multiple dimensions.
The production, supply, storage, transportation, after-sales maintenance services are inseparable from the quality and safety of medical devices. To strengthen regulatory supervision and ensure quality and safety of medical devices, the “new Regulations” stipulate that the NMPA may conduct extended inspections on business entities and individuals that provide products or services in activities such as medical device development, production, operation, and use.
This webinar is to help our audiences better understand and meet the requirements of China’s Good Supply Practices (GSP) and Good Manufacturing Practices (GMP) and be aware of the possible inspections it may receive from NMPA after the product’s market approval.
Agenda
1. Introduction to China’s regulation on medical device sales and production
- Medical Device Operation Quality Management Standards (GSP)
- Measures for the Supervision and Administration of the Production of Medical Devices （GMP）
2. What are the possible types of NMPA inspections after market approval? What are the requirements and how to prepare for it?
- Routine inspection
- Special inspection
- Annual inspection
- Unannounced inspection
- Inspection triggered by replacement of certificate
3. Case study based on hands-on auditing experience
- Common issues found during audit
- Correction plan
- Possible punishment
4. Takeaway and tips
Speaker
Zhe Ji
QA Manager, Inspirative Medical
Zhe has over 15 years of experience in medical device quality assurance as a team leader for product lifecycle supervision in China. She has extensive hands-on experience in handling post-market recalls, adverse events, and inspections, submitting periodic reports, providing trainings, and maintaining communication with China NMPA.
Registration Link
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