Service

Production License Overview

In accordance with Regulations on the Supervision and Administration of Medical Devices (No.650 Decree of the State Council of the People’s Republic of China), on the premise of conditions specified for medical device production, manufacturers of Class II and III medical devices should apply for the Production License from the competent food and drug administration of the province, autonomous region and municipality directly under the central government.

Service Contents

Materials provision

On-site assessment

Collation of system operation

Acceptance of material application

Material review/on-site review

Enterprise correction

Approval notification

Team 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 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

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. Good Manufacturing Practice (No.64 Announcement in 2014)

4. Good Manufacturing Practice Annex on Sterile Medical Devices (No.101 Announcement in 2015);

5. Good Manufacturing Practice Annex on Implantable Medical Devices (No.102 Announcement in 2015);

6. Good Manufacturing Practice Annex on IVD Reagents (No.103 Announcement in 2015)

6. Good Manufacturing Practice Annex on Customized False Teeth (No.195 Announcement in 2016)

7. Good Manufacture Practice Annex on Stand-Alone Software (No.43 Announcement in 2016)

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Relevant Services

Counseling on compliance of the production site

Counseling on compliance of production and inspection equipment

Counseling on team building

Technology counseling on pilot production

Risk evaluation and management of the pilot production process

Preparation of lot production records

Product-related process verification

Counseling on quality management system documents

Application assistance of production licenses for Class II and III medical devices