Import Registration Pathway: Agent, Home-Country Proof and Local Production Transfer

1. Key takeaways

A manufacturer outside China exporting devices into the country faces four substantive differences from the domestic route.

• Centralised authority: import filing for Class I and registration for Classes II and III go to the National Medical Products Administration (NMPA), with technical review by its Center for Medical Device Evaluation (CMDE); domestic Class II sits with the province.
• Mandatory agent: an overseas applicant must appoint a Chinese enterprise legal person as agent, who handles the filing and assists with Article 20, paragraph 1 obligations and liability.
• Origin certificate: proof that the competent authority of the country of registration or manufacture permits sale, waived for an innovative device not marketed abroad.
• Higher fees: import Class II initial registration is CNY 210,900 and Class III is CNY 308,800, about 2.01 times the domestic Class III figure of CNY 153,600.

Announcement No. 30 of 2025, issued 17 March 2025, extends local production to enterprises sharing the registrant actual controller and allows reuse of summary, non-clinical (except technical requirements and test reports) and clinical evaluation materials.

The GRZAN view. The two openings worth evaluating are the China-first route for innovative devices not yet marketed abroad and local production under common control.

2. Legal basis

Administrative regulation. Regulations on Supervision and Administration of Medical Devices, State Council Order No. 739, promulgated 9 February 2021, effective 1 June 2021. Articles 15(2) and 16(2) require an overseas filer or applicant to submit through its appointed Chinese legal person to the NMPA, with proof of overseas marketing waived for innovative devices not marketed abroad. Article 17(2) sets 3 working days to technical review and Article 18(1) 20 working days to a decision; Article 20(2) makes the agent an assistant in fulfilling obligations; Article 21 covers changes; Article 22 gives 5-year validity with renewal 6 months before expiry; Articles 24 and 25 set the clinical evaluation principle and exemptions; Article 27 sets 60 working days for high-risk Class III trial approval, deemed granted without notice.

Departmental rules. SAMR Order No. 47, promulgated 26 August 2021, effective 1 October 2021: Article 5 assigns import Class II and III technical review to the CMDE; Article 14(2) requires the Chinese agent; Article 18 sets the origin certificate rules; Articles 33, 34 and 36 cover clinical evaluation and the two routes; Article 40 sets 60 days with deemed consent; Article 41 requires deficiencies in full at one time and supplements within 1 year; Article 45 requires trials within 3 years of approval; Article 79 makes the agent name and address a filing item; Article 124 repeals the 2014 rules. IVD reagents follow SAMR Order No. 48, promulgated 26 August 2021, effective 1 October 2021, under Article 121 of Order No. 47.

Article 18 of Order No. 47 creates three situations.

Normative documents. Announcement No. 30 of 2025 extends eligibility to enterprises established by the import registrant or sharing its actual controller, and requires a statement with documents such as the latest annual enterprise report. The Special Review Procedure for Innovative Devices, Announcement No. 83 of 2018, published 2 November 2018, effective 1 December 2018, requires a granted core technology invention patent announced no more than 5 years before application (Article 2(1)) and applies early engagement, a dedicated reviewer and scientific review (Article 3).

UDI follows the 2019 System Rules, with Article 15 requiring upload before sale, in three batches under Announcements No. 106 of 2020, No. 114 of 2021 and No. 22 of 2023, the last covering 103 Class II device types in 15 categories. The 2025 clinical evaluation exemption catalogue, Notice No. 19 of 2025, covers 1,047 products; the 2025 IVD trial exemption catalogue, issued 24 June 2025, covers 445, of which 418 are Class II and 27 Class III. Guobanfa No. 53 of 2024 sets 24 measures in five areas. Import fees are CNY 210,900 initial, CNY 42,000 variation and CNY 40,800 renewal for Class II, and CNY 308,800, CNY 50,400 and CNY 40,800 for Class III, with CNY 43,200 for a high-risk trial application.

3. Expert insights

The agent is a responsibility node, not a mailbox. A courier arrangement breaks at the first adverse event, recall or traceability request, because the agent holds no decision mandate and the overseas entity has no local capacity. The authorisation letter should list adverse event reporting, recall execution, UDI maintenance and regulatory communication item by item.

The origin certificate has three tiers, and the third is the real opening. A device not marketed abroad may be registered directly, and with early engagement this forms a China-first channel. The constraint is a core technology patent announced no more than 5 years before application, with the special review request filed before the first registration application.

Local production under Announcement No. 30 of 2025 has a clear data boundary. Eligibility now covers enterprises sharing the same actual controller as the import registrant, but the technical requirements and test reports cannot be reused, since they must show conformity with Chinese mandatory standards, which differ in transposition from IEC and ISO.

Fees and deficiency time belong in one budget. The larger risk is the 1 year allowed for a single supplement, which must absorb headquarters retrieval, multilingual translation, origin certificate updates and internal approvals. A practical estimate of three to six months for a response is prudent, with a risk alert beyond nine months; this is a practical estimate, not a statutory limit.

Chinese labelling and UDI consistency is a frequent inspection point. Article 9 of Order No. 6 requires Chinese text, other languages yielding to the Chinese version, and Articles 10(2) and 13(2) require the agent name, address and contact details. The common defect is a mismatch between the Chinese label, the source label and the UDI record for the same UDI-DI.

4. Practical recommendations

• Select the agent on compliance capability, not registration errands. Verify the trading licence, quality system and local recall capacity, then define duties in the authorisation letter.
• Start the origin certificate six months ahead. Check the issuing body, validity, notarisation and translation, and prepare the innovative review file in parallel.
• Build a terminology table once. Fix names, addresses, models and warnings at kick-off and reuse them across all documents.
• Compare pathways at the kick-off review. Conventional registration, innovative review, priority review and local production should be assessed together with a written conclusion.
• Decide testing and unit division together. Self-testing must meet Announcement No. 126 of 2021 and the 2025 guideline; commissioned testing needs a booked qualified institute.
• Put post-market duties in the agent agreement. Adverse event reporting, traceability, recall, UDI maintenance and instruction changes belong in contract clauses.
• Prepare for the new good manufacturing practice from 1 November 2026. Announcement No. 107 of 2025 has 15 chapters and 132 articles, adding quality assurance, verification and confirmation, and contract manufacturing and outsourcing.

5. Verification checklist

• □ Class confirmed or determination completed.
• □ Receiving authority confirmed as the NMPA for all import routes.
• □ Chinese legal person appointed as agent, with duties specified.
• □ Agent name and address filed.
• □ Origin certificate checked, or the exemption confirmed.
• □ Innovative or priority eligibility assessed within the 5-year patent window.
• □ Registration unit division and model coverage fixed.
• □ Technical requirements aligned with Chinese mandatory standards.
• □ Test report source and schedule fixed.
• □ Clinical evaluation route and difference evidence settled.
• □ Chinese instructions and labels state the agent details.
• □ UDI assigned and uploaded, with a three-source comparison completed.
• □ Fee budget calculated on the current NMPA catalogue.
• □ Renewal window of 6 months before expiry tracked.

Regulatory information verified as at 29 October 2026 against NMPA, SAMR and State Council publications; content marked as a practical estimate has no legal effect.

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 manages National Medical Products Administration (NMPA) registrations, coordinates typetesting at qualified testing institutes, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com