The Guangdong government released the “Guideline on Registration of Approved Class II Medical Devices Moving into Guangdong Province (Trial)” to encourage medical device and IVD manufacturers to transfer the certificates into Guangdong province.
The Guangdong NMPA will process the transfer in 5 working days if the product classification is clear and the clinical evaluation evidence is sufficient.
The guideline also applies to overseas manufacturers, through its sole proprietorship, joint venture, or authorized registration applicant in Guangdong, to transfer the imported Class II medical device and IVD registration certificate to Guangdong.
Advantage of Transfer Device Certificate to Guangdong
The advantage of localizing device production is that devices will become more competitive in the Guangdong market, as hospitals are giving preference to Guangdong local products during public tenders. Guangdong is the most populous province of China, and its economy is larger than that of any other province in the nation.
It provides an expedited register pathway for the devices to get Guangdong certificate, when the main raw materials, production processes and quality management system don’t change. They can reuse some of the deliverables that were submitted for obtaining the registration certificate.
Either the research summary or the clinical evaluation report can be reused. But the New Product Technical Requirements and new Product Registration Testing Reports are still required, though.
One prerequisite for utilizing this guideline is that the Class II devices transferring to Guangdong must already receive approval. Under this new pathway, the simplified list and the re-evaluation process will greatly facilitate the localization of those devices.
Highlights in Guideline
- For registration, applicants shall refer to the “Medical Device Registration Dossier Requirements and Document Format” and “In Vitro Diagnostic Reagent Registration Dossier Requirements and Document Format”.
- For summary data, non-clinical data (excluding registration test reports), and clinical evaluation data, the original dossier can be utilized for the transfer.
- During registration inspection, inspectors will focus on the consistency and traceability of the quality management system regarding the production technology and material, etc.