Country-of-Origin Approval Documents: Three Scenarios, Legalisation and Exemptions

1. Key takeaways

Proof of marketing approval in the country of origin is often simplified in preparation and challenged at acceptance. Its difficulty lies not in obtaining it but in the verifiability of the issuer and the consistency of the product data.

• Both import registration and import filing require the country-of-origin marketing document. Article 18 of the Registration and Filing Measures applies one requirement to Class I import filing and to Class II and Class III import registration.
• The document is handled in three tiers. If the product is marketed in the country of origin, submit the competent authority’s permission to sell. If that country does not regulate it as a medical device, submit documents showing it may lawfully be sold there. For an innovative device not marketed abroad, no document is required.
• The exemption sits at the level of an administrative regulation. Articles 15 and 16 of the Regulations attach the words may be dispensed with for innovative devices not yet marketed abroad, so the exemption is not a relaxation of departmental practice.
• The document must pass four checks: a competent issuer, consistent product information, validity, and acceptable language and authentication. Submission alone does not secure acceptance.
• Chinese language and original text are mandatory. Article 17 requires materials in Chinese, with the original foreign-language text alongside any translation.
• Lapse of the document affects approved products. Where marketing status in the country of origin changes materially, the holder must assess whether a variation or report is triggered.

In our assessment, the tiers are often inverted: applicants claim the innovation exemption first and return to the second tier only after a deficiency notice, by which time the correction window has closed.

2. Legal basis

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

• Article 16, paragraph 2: the overseas applicant for Class II and Class III devices submits registration materials and proof of overseas marketing through a designated China-incorporated enterprise legal person; for innovative devices not marketed abroad, that document may be dispensed with.
• Article 15, paragraph 2: the overseas filer of Class I devices submits filing materials and the proof of overseas marketing through the same designated entity.

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

• Article 17: registration and filing materials shall be in Chinese; where translated from a foreign-language source, the original shall be provided at the same time; where unpublished literature is cited, the rights holder’s permission is required.
• Article 18: import registration and filing shall include a document from the competent authority of the country or region of the applicant’s registration or manufacture permitting marketing. Where the country of origin does not regulate the product as a medical device, relevant documents are required, including proof of lawful sale there. For innovative devices not marketed abroad, the document is not required.

Announcement on the Requirements for Medical Device Registration Submission Dossiers and the Format of Approval Documents (NMPA Announcement No. 121 of 2021, promulgated 29 September 2021, effective 1 January 2022): sets the composition of the import dossier and the approval document format; the country-of-origin proof is part of the dossier.

Practical estimate. Notarisation and legalisation requirements for documents executed abroad, including consular legalisation, are not harmonised. The accepted form follows the receiving department’s current requirements and the annex to Announcement No. 121 of 2021. Confirm at project start whether the issuing country benefits from simplified arrangements.

Practical estimate. The rules set no single test for innovative. Practice weighs entry into the special review procedure for innovative devices, a core Chinese invention patent, and whether the device is a domestic first; the receiving and reviewing departments decide.

3. Expert insights

The three tiers are a sequence, not a menu. Article 18 sets a fixed order, and reversing it produces the wrong dossier.

The tiers are easily confused. A second-tier product is lawfully sold at home but under another category, such as an IVD handled as laboratory supplies or a food supplement. A third-tier product has no overseas marketing record at all.

The status of the exemption determines its durability. The words may be dispensed with appear in Articles 15 and 16. A relaxation in a departmental document can tighten with review practice; an exemption in a regulation changes only by amendment. For China-first products this turns an apparent obstacle into a workable route, and pairs with the special review procedure: innovation status secures the channel, the exemption removes the documentary threshold.

The issuing body is the first gate. Article 18 requires a competent authority document permitting marketing, yielding three levels of reliability.

The test is whether the issuer may make an administrative decision permitting sale; a self-declaration or a commercial letter does not. In second-tier cases, obtain a document from the body that holds market-entry authority.

Four consistency checks decide acceptance. Product name: correspondence between the certificate name and the Chinese submission name, explained where they differ. Model: whether every submitted model is covered, especially in multi-model units. Manufacturer and address: names and addresses must match the dossier, site by site. Validity: certificates of free sale expire and must remain valid at acceptance and during review. The address check is most often skipped; a document covering one site of a multi-site manufacturer leaves a gap.

4. Practical recommendations

• Decide the tier at project initiation. Record a written conclusion against the three questions, with evidence, so the tier is not changed after acceptance.
• Lock the issuer and keep the delegation basis. Prefer a national regulator’s document; where only a local or delegated body will issue, obtain the official basis for its authority.
• Run the four checks before submission. Compare name, models, manufacturer and addresses, and validity against the dossier, and archive a one-page comparison sheet.
• Work in the order original, authentication, translation. Complete notarisation and legalisation first, then produce the Chinese translation with the original attached, matching issuer name, document number and date exactly.
• Standardise terminology. Keep a glossary across all dossiers from the same overseas holder so that one entity has a single Chinese name throughout.
• Assemble three sets of evidence for an innovation claim: a statement covering technical generation and differences from marketed devices, the Chinese core invention patent certificate with grant publication within 5 years, and a declaration and evidence of no overseas marketing.

5. Verification checklist

• □ The tier decision was made in the three-question order, with the conclusion and evidence archived.
• □ First tier: a marketing permission from the competent authority of the country of registration or manufacture is held.
• □ Second tier, if applicable: a statement that the country of origin does not regulate the product as a device, plus proof of lawful sale.
• □ Third tier, if applicable: an innovation statement with supporting evidence and a declaration of no overseas marketing.
• □ The issuer is a national or regional competent authority, or the delegation basis is attached.
• □ The correspondence between the certificate name and the Chinese submission name is explained.
• □ Every submitted model is covered, and multi-model units were checked one by one.
• □ Manufacturer names and manufacturing addresses match the dossier, with multiple sites listed individually.
• □ The document is valid at acceptance and for the expected review period, with renewal scheduled.
• □ Foreign documents are notarised and legalised as the receiving department currently requires.

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