Service

1. Service Description

When a list of non-conformities is given after the external audit, we can make a corrective action plan based on it.

The GMP consulting team of Tigermed-Jyton Group can provide:

Customized writing for single processes;

Preparation of the system correction plan;

Preparation of other relevant documents.

2. Service Advantages

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.

3. Service Process

System audit by a third party — Analysis on the list of nonconformities — Preparation of correction plans — Validation of corrective actions

4. Regulatory Bases

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