Technical File preparation
NMPA submissions
The contents of preparing Submission Technical File are rapidly changing over the years accompanied by the updated China governance MD supervision regulations and registration administration measures.
China is currently following the IMDRF working document to review the Table of Contents as its TF checklist, and IMDRF clinical guidance documents to require the clinical evaluation files. A good starting point is to get familiar with these international documents and perform internal gap assessment. Another new requirement for foreign manufactures is part of their oversea quality system files are requested to be included in the submission package.
Technical File Submission Checklist
In 2022 there is a Technical File Submission Checklist for imported class II and class III devices. The checklist contains of 6 chapters.
Chapter 1 | Regional administrative
Chapter 2 | Submission context
Chapter 3 | Non-clinical evidence
Chapter 4 | Clinical evidence
Chapter 5 | Labelling and promotional material
Chapter 6A | Quality Management System procedures
Chapter 6B | Quality Management System device specific information
Qserve can help you out to perform the gap assessment of your existing files against China's requirements.
Qserve China
Qserve China, a subsidiary of Qserve Group, is a localized consulting company based in Beijing and Nanjing, China. Under international management structure with local regulatory experts’ delivery team, we have helped hundred clients at home and abroad successfully obtain China health authority approval since 2011.
Dedicated on medical devices and in vitro diagnostics only, we have a team of diversified consultants to help with broad range of products ranging from class I to class III, active device to non-active device, and from venture startups to multiple-national corporations.
By maintaining a regular contact with local test engineers, authority officers and technical reviewers, we are aligned with regulatory information, provide insight interpretation to guide clients through from China regulatory process, and make a difference to access availability.