A proposed pathway for related applicants
NMPA published a consultation on September 29, 2026, proposing common requirements for cross-province registration of devices that already hold a Chinese domestic registration certificate. The notice was signed by NMPA’s Comprehensive Department on September 28. Comments are requested before October 30, 2026. The proposal remains a draft and has not taken effect.
Eligibility would be limited to products with a valid domestic certificate that fall within Class II or III under the current classification rules and catalogue. The registered product name, structure and composition or main components, and intended use would have to remain unchanged. The new applicant would need to be an enterprise established by the original registrant, or an enterprise under the same actual controller.
The applicant could manufacture in its own province or commission the original manufacturer, subject to restrictions on devices for which contract manufacturing is prohibited. Class II applicants would submit an initial registration application to their provincial regulator; Class III applicants would apply to NMPA. This is a registration pathway requiring approval, rather than automatic certificate transfer.
Reusing evidence while checking the new manufacturing arrangement
The draft would allow reuse of original overview materials, specified nonclinical materials, and clinical evaluation materials, including relevant registration changes, filings, and reports. The safety and performance principles checklist, product technical requirements, and test reports are excluded from the general nonclinical reuse provision. Technical requirements and testing would need to demonstrate compliance with applicable mandatory standards, and the annexes call for test reports on products made at the actual manufacturing site.
Applicants would also submit evidence of their relationship with the original registrant, authorization to use the original dossier, and the required commitments. The new applicant’s quality system would be assessed for its ability to manage product safety, effectiveness, and quality, including risks arising from a change of registrant or manufacturing address. Certain inspections could be combined or reduced when the draft’s conditions are met.
For IVDs, the annex additionally calls for production and testing records from three different batches manufactured at the current actual site within the six months before the application. Historical batches from the original registrant could not satisfy that requirement.
The new certificate would identify the original certificate number. The draft’s main text says the original registrant should proactively cancel the original certificate within three months after cross-province approval; the supporting commitment and annex language instead refers to applying for cancellation procedures. If the original certificate is not cancelled within the period, the original issuing authority would announce its cancellation. The wording difference is a point companies may wish to address during consultation.
What companies can check now
- Confirm certificate validity, current classification, and the applicant’s qualifying relationship with the original registrant.
- Map dossier reuse against current mandatory standards, actual-site testing, and differences in the quality system and manufacturing process.
- For IVD projects, plan the three recent production batches and their records; for all projects, assess the proposed certificate-cancellation sequence.
- Use NMPA’s feedback form to submit specific comments to ylqxzc@nmpa.gov.cn before October 30, with the subject line “优化跨省注册反馈意见”.
Companies considering relocation or a change of registrant can use the consultation to identify evidence gaps and comment on the proposed process. Filing decisions should follow the applicable current requirements while the final text is pending.
Sources
- Primary official source国家药监局综合司公开征求《关于优化已取得医疗器械注册证产品跨省注册的规定（征求意见稿）》意见 (opens in a new tab)National Medical Products Administration
- Supporting source国家药监局关于优化已取得医疗器械注册证产品跨省注册的规定（征求意见稿） (opens in a new tab)National Medical Products Administration
- Supporting source意见反馈表 (opens in a new tab)National Medical Products Administration