Import-to-Domestic Production Transfer: Eligible Entities and Data Reuse

1. Key takeaways

Announcement No. 30 of 2025 lets an imported device migrate to domestic manufacture while carrying over part of its original dossier. The value lies in reusing evidence, not in saving fees.

• The governing instrument is the NMPA Announcement on Further Adjusting and Optimising Domestic Production of Imported Medical Devices (No. 30 of 2025, published 17 March 2025), which refines the earlier rule.
• Eligible entities expanded from one category to two: an enterprise established by the import registration holder, and an enterprise under the same actual controller as the holder. The second is the core addition.
• Three dossier parts may be carried over: the summary, the non-clinical data except product technical requirements and test reports, and the clinical evaluation data.
• Product technical requirements and test reports fall outside reuse and must be redrafted and re-tested to domestic requirements. This is the decisive dividing line.
• Common control must be evidenced by an explanatory statement and supporting documents, including the enterprise annual report closest to the application date that shows the actual controller.
• Legal relationships are rebuilt. The holder becomes a domestic entity, the import agent regime ceases to apply, and the mandatory agent details in instructions and labels fall away.
• Fees change with the structure: import Class II first registration is CNY 210,900 and import Class III CNY 308,800, against CNY 153,600 for domestic Class III; domestic Class II rates are set by provincial pricing and finance departments.

In our assessment, what is genuinely reused is the slowest evidence, the non-clinical and clinical packages, while what must be redone is what binds to the domestic manufacturing reality. Draw that boundary precisely and the schedule shortening becomes real.

2. Legal basis

Medical Device Supervision and Administration Regulations (State Council Order No. 739, promulgated 9 February 2021, effective 1 June 2021)

• Article 32: Class II and Class III manufacture requires a production licence from the provincial authority, decided within 20 working days of acceptance and valid for 5 years.

Medical Device Registration and Filing Measures (SAMR Order No. 47, promulgated 26 August 2021, effective 1 October 2021)

• Article 6: provincial authorities handle domestic Class II review and approval, and quality system inspections for domestic Class II and Class III registration.
• Article 19: products shall meet applicable mandatory standards, with a reasoned explanation where a standard does not apply.

Provisions on the Administration of Medical Device Instructions and Labels (former CFDA Order No. 6, promulgated 30 July 2014, effective 1 October 2014)

• Article 10(2) and Article 13(2): instructions and labels of imported devices shall state the agent’s name, domicile and contact details.
• Article 16: the content of instructions reviewed at registration may not be altered without authorisation.
• Article 32: an applicant may submit a self-test report or a report from a qualified medical device testing institution.

Measures for the Supervision and Administration of Medical Device Production (SAMR Order No. 53, promulgated 10 March 2022, effective 1 May 2022)

• Article 13: a production licence decision is made within 20 working days of acceptance, with the certificate issued within 10 working days of approval; the on-site inspection may be combined with the registration system inspection.

Announcement No. 30 of 2025 extends eligibility to enterprises established by the holder or under the same actual controller, permits reuse of the summary, non-clinical data (excluding technical requirements and test reports) and clinical evaluation data, and requires a common-control statement with supporting documents including the latest annual report. The predecessor is Announcement No. 104 of 2020.

Practical estimate. No quantitative shareholding threshold is set for common control: equity, voting arrangements and contractual control can support it, with the receiving department deciding. Domestic Class II fees vary by province, with some charging CNY 40,670 per registration unit, so verify the current standard at initiation.

3. Expert insights

The expansion of eligible entities carries the most commercial value.

The addition solves a real problem: in multinational groups the import certificate is often held by the overseas parent while the Chinese manufacturer sits under an intermediate holding company. The former rule demanded direct investment; a control test now suffices. The third row still fails, so the policy has not opened to arbitrary contract manufacturing.

Reusable material is a three-part list with express exclusions.

Material describing what the product is can travel; material describing where and how it is made cannot. Technical requirements are the testing benchmark and reports address actual samples under Article 32, so both bind to the domestic manufacturer.

Why the technical requirements must be rebuilt: four technical reasons. First, mandatory standards differ: overseas versions reference IEC or ISO while domestic registration requires comparison with Chinese GB and YY standards, where limits and methods may diverge under Article 19. Second, samples must come from a domestic batch. Third, the testing body changes under Article 32. Fourth, model and naming must match the domestic registration unit. Translating the overseas text and submitting it directly is the most common cause of refusal; our practice is a clause-by-clause gap analysis before redrafting in Chinese.

The legal reconstruction matters more than the dossier reuse.

Class II changes most sharply: acceptance moves from NMPA to the province, and both technical review and system inspection change hands, so provincial practice and local system readiness must be assessed together.

4. Practical recommendations

• Determine eligibility before assessing reuse. Confirm in writing that the domestic manufacturer is established by the holder or shares its actual controller.
• Assemble the common-control evidence early in three layers, structural, documentary and declaratory, using the enterprise annual report closest to the application date.
• Run a clause-by-clause gap analysis of the technical requirements, producing a three-column table of carry-over, revise and add, with reasons for any mandatory standard deemed inapplicable.
• Fix the testing route early. Choose self-testing or a qualified institution under Article 32, ensure samples are representative, and test before applying.
• Run the production licence and the registration in parallel. The licence decision takes 20 working days and issuance 10 working days (Production Measures, Article 13), and the on-site inspection can be combined, so place both in one window.
• Reset the counterparts. Class II moves to the provincial authority while Class III stays with NMPA, and agent, system inspection and trial site contacts change accordingly.

5. Verification checklist

• □ Eligibility is determined: an enterprise established by the import holder, or one under the same actual controller.
• □ The common-control statement and evidence are complete, with the annual report closest to the application date.
• □ Reuse scope is confirmed: summary, non-clinical data (excluding technical requirements and test reports), clinical evaluation.
• □ The product technical requirements were redrafted to domestic requirements, not carried over.
• □ Test reports were reissued by self-testing or a qualified institution.
• □ Sample representativeness was checked, and testing was completed before submission.
• □ Mandatory standards were compared item by item, with reasons given where not applicable (Article 19).
• □ The domestic manufacturer holds or has applied for a production licence, with the 20 working day window scheduled.
• □ The accepting body is confirmed: provincial for Class II, NMPA for Class III.
• □ The system inspection body is confirmed as provincial for domestic Class II and Class III (Article 6).

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Chinese market. Our team acts as the in-China registration agent, coordinates import agent and distributor arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com