China Export Sales Certificate: New Rules for Taking Devices Overseas

1. Key takeaways

The 2025 Provisions on the Administration of Export Sales Certificates for Medical Devices divide the certificate into two categories: Category I for products already registered or filed in China, and Category II for products not registered or filed in China and developed specifically for overseas markets.

• The two certificates correspond to two product identities. Whether a domestic registration certificate or filing voucher exists is the first dividing line.
• The split answers a long-standing practical difficulty: a product made only for export cannot prove its compliance status through the ordinary domestic route.
• Quality system status is an implicit precondition. For registered or filed products it derives from the existing licence or filing; for export-only products it must be demonstrated separately.
• The export certificate and destination-country registration are two systems. The certificate explains domestic compliance status; it does not replace the approval procedure abroad.
• Timing should be read together with the manufacturing practice revision (Announcement No. 107 of 2025, effective 1 November 2026, 15 chapters and 132 articles).

2. Legal basis

Administrative regulation. Medical Device Supervision and Administration Regulation (State Council Order No. 739), promulgated 9 February 2021, effective 1 June 2021. Article 13: Class I filed, Class II and III registered, with lifecycle liability. Article 20, paragraph 1: five duties, the first concerning the quality system. Article 32: Class II and III production requires a licence, decided within 20 working days, valid five years.

Departmental rules. Measures for the Administration of Medical Device Registration and Filing (SAMR Order No. 47), promulgated 26 August 2021, effective 1 October 2021.

• Article 14, paragraph 2: the overseas applicant or filer designates a Chinese legal entity as agent. Article 15: quality system.
• Article 18: three tiers of origin-country marketing evidence for import registration — a certificate where the product is marketed there, access documents where it is not regulated as a device there, and no document where an innovative device is not yet marketed abroad.
• Article 123: devices from Hong Kong, Macao and Taiwan follow the imported-device route.

Production rules. Measures for the Supervision and Administration of Medical Device Production (SAMR Order No. 53), promulgated 10 March 2022, effective 1 May 2022. Article 4: classified production, Class II and III under licence, Class I under filing. Article 13: decision within 20 working days. Article 14: licence valid five years. Article 22: Class I filing, with inspection within three months.

Normative documents. Provisions on the Administration of Export Sales Certificates for Medical Devices (issued 2025): the document number and publication date are outside the verification scope of this paper and must be checked against the official text. The Provisions create the two categories described above. Good Manufacturing Practice for Medical Devices (Announcement No. 107 of 2025), 4 November 2025, effective 1 November 2026, 15 chapters and 132 articles, repealing Announcement No. 64 of 2014.

Practical estimate. The authority level, material list, processing time, validity period and renewal route are not held here as verified text. The points below are industry practice and a practical estimate; confirm current requirements with the provincial drug administration before applying.

3. Expert insights

The dividing line is domestic identity, not product risk.

The test is whether domestic registration or filing has been completed (Article 13), not the management class or risk level. A registered Class III product takes Category I; a Class I product developed only for export and not filed takes Category II. Guessing the category from risk level is the commonest application error.

The design also recognises export-only products, which previously had no official identity statement to offer a destination authority.

A mirror image of the origin-country proof required on import.

The third tier of Article 18 and Category II share a logic: both leave a channel for products that cannot yet obtain identity by the traditional route.

System status is an implicit precondition, proven differently by identity.

The second row is the most neglected: certificate and production licence belong to different parties, so a registration certificate alone does not reflect the production arrangement (Article 34); an entrustment statement should accompany it (practical estimate).

The certificate does not replace destination approval. It states domestic compliance and production status; it is not a marketing authorisation abroad.

Export plans often schedule the certificate after destination registration begins, leaving the dossier incomplete; starting it first and folding it into the package works better (practical estimate).

Overlap with the 2026 practice conversion. The system description in the certificate will follow the revised practice. A Class I product faces inspection within three months of production filing (Article 22), and if the new version is in force by then, the standard applied rises accordingly.

Generality across markets. GRZAN serves clients in China, the EU, the United States, the United Kingdom, Switzerland, Canada, Australia, Japan, Korea, Russia, Brazil, Mexico, Indonesia, Malaysia, Thailand, Vietnam, India, Saudi Arabia, the UAE and South Africa, and acceptance of domestic compliance evidence differs by market.

The third group stalls schedules: translation, notarisation and authentication are several further steps with their own time cost. Running them in parallel with the certificate shortens the cycle (practical estimate).

4. Practical recommendations

• Classify before preparing materials: confirm whether a domestic certificate or filing exists (Article 13), then choose Category I or II, not by management class.
• Prepare a relationship statement for entrusted production where certificate and licence sit with different parties (Article 34).
• Start the certificate before destination registration, since it forms part of that package (practical estimate).
• Plan translation and authentication in advance, listing each destination’s requirements and scheduling them alongside the certificate.
• Check that the certificate matches the registration particulars — name, model and specification, certificate number — since mismatches prompt questions abroad.
• Align with the 1 November 2026 conversion, and for Class I exporters complete self-checking early (inspection within three months).
• Keep a version ledger of export certificates recording issue date, coverage and validity, and confirm current requirements with the provincial administration first.

5. Verification checklist

• □ Category I or II confirmed on domestic registration or filing status
• □ Certificate or filing voucher for Category I within validity
• □ Category II statement prepared on export-only status
• □ Entrustment relationship statement prepared (Article 34)
• □ Licence or filing status consistent with the application (Article 4)
• □ Name, model and certificate number identical to the registration particulars
• □ Authority level and material list confirmed with the province
• □ Translation, notarisation or authentication scheduled in parallel
• □ Certificate obtained before the destination filing starts
• □ Class I exporters self-checked (inspection within three months)
• □ System description aligned with the Announcement No. 107 conversion (effective 1 November 2026)

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 adverse event monitoring and recall filings with NMPA, maintains UDI compliance, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com