NMPA published the Draft Document of “Transfer Certificate of Approved Imported Device to Domestic Enterprise for Manufacturing” on March 5, 2020 for feedback. Feedbacks need to be submitted by March 31, 2020.
The NMPA announcement encourages foreign manufacturers to localize their approved devices in China. Overseas companies can now claim their products domestic-made with much simpler re-registration process in China. This allows foreign-made products quickly become China-made and commercialize on the Chinese market a lot simpler and faster. As hospital public tenders encourage more domestic made products, this new NMPA announcement will make product transfer from overseas manufacturing site to China manufacturing site faster and simpler.
When the announcement is officially implemented, , transferring products from overseas manufacturing site to China site will take much less time. The prerequisite to utilize this guideline is the devices being transferred from overseas must have initially been approved as an import device.
The highlights of the draft document:
- The local entities can be fully foreign funded.
- The policy only applies to Class II and Class III medical devices and IVDs.
- Registration shall refer to the “Medical Device Registration Dossier Requirements and Document Format” and ” In Vitro Diagnostic Reagent Registration Dossier Requirements and Document Format”.
- Original dossier submitted for imported device registration can be utilized, such as executive summary, clinical evaluation data, risk analysis, main raw materials data, performance evaluation, positive value determination or reference interval determination data, stability data, etc.
- Both overseas manufacturers and their China entities are to be responsible for the consistency of original registration dossier and later submission.
- E-submission is recommended.
- GMP system inspection and product inspection shall be conducted by NMPA as same time
- GMP system for the country-of-origin shall be provided in the inspections.
- Inspections will compare the domestic production quality management system and overseas quality management system: the consistency and traceability of product design, procurement control, quality control, etc.
For the English version of the “Transfer Certificate of Approved Imported Device to Domestic Enterprise for Manufacturing” or any documents mentioned above, please email info@ChinaMedDevice.com.