Simulated assessment: At the first registration stage of the medical device, we perform a simulated assessment for the factory before on-site assessment by the NMPA assessor. It is an in-process service to find out and fix any possible problem in advance. It is generally needed before product marketing.
Simulated flight inspection: A simulated inspection is performed in accordance with the flight inspection requirements after medical device registration and before flight inspection by NMPA. It is an in-process service to find out and fix any possible problem in advance. It is generally needed after product marketing.
Internal audit guidance: The enterprise may periodically perform the internal audit as needed. The third-party assistance for internal audit is needed due to reasons such as experience, conventional thinking and avoidance. It is generally needed after the establishment and operation of the system. This service is needed upon change of the management layer, change of the product line and periodic internal audit, etc.
Simulated assessment processes
Tigermed-Jyton Medical Device Innovation and Development Technology Service Platform has a team which has almost 20 years’ experience in medical device regulations and Good Manufacturing Practice (GMP). Experts of the team participated in the national special supervision and inspection organized by NMPA for several times, and served as the leader of the special supervision and inspection group. They participated in the regulation amendment discussion organized by NMPA for several times, and participated in drafting and amending multiple local supervision and administration regulations for medical devices. They have strong abilities to comprehensively analyze, judge and handle compliance affairs of enterprises which manufacture and operate medical devices. They can provide professional guidance and assistance on establishing and maintaining the quality management system, legally and reasonably mitigating policy risks, and exercising risk control management and performing various verification activities.
Relevant Regulations and Standards
1. Regulations on the Supervision and Administration of Medical Devices (No.650 Decree of the State Council of the People’s Republic of China)
2. Measures for Supervision and Administration of Medical Device Production (No.7 Order of CFDA)
3. Measures for Flight Inspection of Drugs and Medical Devices (No.14 Order of CFDA)
4. Good Manufacturing Practice (No.64 Announcement in 2014)
5. Good Manufacturing Practice Annex on Sterile Medical Devices (No.101 Announcement in 2015);
6. Good Manufacturing Practice Annex on Implantable Medical Devices (No.102 Announcement in 2015);
7. Good Manufacturing Practice Annex on IVD Reagents (No.103 Announcement in 2015)
8. Good Manufacturing Practice Annex on Customized False Teeth (No.195 Announcement in 2016)
9. Good Manufacture Practice Annex on Stand-Alone Software (No.43 Announcement in 2016).
10. GB/T 19001 Quality management system — Requirements
11. YY/T 0287 Medical devices—Quality management systems—Requirements for regulatory purposes