NMPA published the final notice “Issues regarding Approved Imported Medical Devices Manufactured by Chinese Domestic Enterprises” on September 25, 2020. The draft version was released on March 5, 2020.
The NMPA announcement encourages foreign manufacturers to localize their approved devices’ production in China. It provides an expedited approval pathway for their medical devices made in China. This pathway first becomes available when the main raw materials and production processes don’t change. You should also make sure the quality management system is consistent with the previous one.
When an overseas company intends to manufacture their approved devices in China, they need a Chinese entity. This entity acts as the domestic license holder. They can reuse some of the deliverables that were submitted for obtaining the imported license. This change accelerates the registration process as the localized device doesn’t need to go through the same time-consuming process.
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. The advantage of localizing device production is that devices will become more competitive in the market. More hospitals will begin to give preference to Chinese domestic products during public tenders.
One prerequisite for utilizing this guideline is that devices transferring to China must already receive approval as an imported device. Under this new pathway, the simplified list and the re-evaluation process will greatly facilitate the localization those devices.
Highlights of the Notice
- The policy only applies to Class II and Class III medical devices and IVDs.
- For registration, applicants shall refer to the “Medical Device Registration Dossier Requirements and Document Format.” They can also refer to “In Vitro Diagnostic Reagent Registration Dossier Requirements and Document Format.”
- After the original dossier is submitted for imported device registration, it can be utilized for the registration of the domestic products. This includes summary, research materials, clinical evaluation report, risk analysis report, IVD products research materials on raw materials, performance testing materials, materials for positive value or scope, stability materials.
- Both the overseas manufacturer and their China entity shall ensure the new domestic registration materials are consistent with the original registration dossier for the imported devices.
- E-submission is recommended.
- NMPA shall focus on the consistency and traceability of the domestic quality management system and the overseas quality management system regarding the production technology and material, etc.
Key Takeaways for Overseas Manufacturers
- Does the certificate transfer apply to the pilot program of the Market Authorization Holder (MAH)?
The purpose of the certificate transfer is to optimize the registration application materials. The manufacturing of imported medical device in domestic enterprises within the existing legal framework.
Products should be produced by foreign-invested enterprises established in China by the registrant of imported medical devices. They are not within the scope of the pilot program of the medical device registrant system. They cannot be commissioned for manufacturing.
- What are the requirements for the validity period of the original registration certificate?
The certificate transfer applies to products whose original imported registration certificate has not expired or withdrew.
- What is the relationship between the newly obtained registration certificate and the original imported device certificate?
The announcement clarifies what happens if a registration application is approved and transferred. Note that the remarks column of the registration certificate should include the registration number of the original imported product.
This shows that the regulatory authorities at all levels can check for identification and traceability. But the domestic certificate and the original imported device certificate are independent of each other and managed separately.
For the English version of the “Issues regarding Approved Imported Medical Devices Manufactured by Chinese Domestic Enterprises” or any documents mentioned above, please email info@ChinaMedDevice.com.
NMPA produced the “Medical Device/In Vitro Diagnostic Reagent Registration and Application Data Requirements” guide with imported devices to be manufactured in China. For an English copy please email info@ChinaMedDevice.com.