Article 17 of SAMR Order No. 47 requires Chinese registration and filing material, with the original supplied when translated from foreign-language material. Article 9 of the 2014 instructions and labelling provisions requires Chinese text and makes Chinese the governing version when other languages are added. Confirm the product-specific dossier and attestation requirements before submission.
Compiled from public official sources. The source retrieval dates below apply to the cited findings; this editorial review does not revalidate every provision or current standard edition. A language requirement marked to verify has not been established from the cited text. Confirm current product-specific requirements before filing or making an external commitment.
Each row states what was established, the provision it rests on, and when it was retrieved. Rows marked to verify are ones this research could not settle against an official provision — they are shown rather than omitted.
| Document | Chinese required | Detail | Basis | Source |
|---|---|---|---|---|
| Registration dossier | Required | Registration and filing material must use Chinese; where translated from foreign-language material, the original must be supplied as well. Confirm the detailed dossier and signature or seal requirements for the actual procedure. Procedure-specific signature, seal or translator declaration requirements were not revalidated in this review. | Measures for the Administration of Medical Device Registration and Filing, SAMR Order No. 47 (2021), Article 17 | www.samr.gov.cn2026-10-11verifiable |
| Instructions for use | Required | Devices sold or used within China must carry instructions for use. Other languages may be added, but the Chinese text governs. Content must agree with the registered or filed content. | Provisions on Medical Device Instructions for Use and Labelling, Article 9 | yjj.sh.gov.cn2026-10-11verifiable |
| Labelling and packaging text | Required | Text must be in Chinese; other languages may be added, with the Chinese governing. Imported devices without the required Chinese labelling and packaging text may not be sold or used. Labelling must agree with the instructions for use and with the registered content. | Provisions on Medical Device Instructions for Use and Labelling, Articles 4 and 9 | yjj.sh.gov.cn2026-10-11verifiable |
| Technical documentation and test reports | Required | Where this material forms part of registration or filing documentation, Article 17 requires Chinese and the foreign-language original where a translation is supplied. Procedure-specific signature, seal or translator declaration requirements were not revalidated in this review. | Measures for the Administration of Medical Device Registration and Filing, SAMR Order No. 47 (2021), Article 17 | www.samr.gov.cn2026-10-11verifiable |
| Clinical evaluation material | Required | Where this material forms part of registration or filing documentation, Article 17 requires Chinese and the foreign-language original where a translation is supplied. Procedure-specific signature, seal or translator declaration requirements were not revalidated in this review. | Measures for the Administration of Medical Device Registration and Filing, SAMR Order No. 47 (2021), Article 17 | www.samr.gov.cn2026-10-11verifiable |
| Quality management system documentation | To verify | Chinese applies where the material forms part of the registration dossier. A provision covering QMS documentation generally could not be located. Carried as open — see gaps. | Not established in this research | www.nmpa.gov.cn2026-08-26portal only |
| Adverse event reports and recall documentation | To verify | A specific language provision for these reports was not established from the cited material. Confirm the reporting route and documentation requirements before submission. Carried as open — see gaps. | Measures for Medical Device Adverse Event Monitoring and Re-evaluation | www.nmpa.gov.cn2026-08-26verifiable |
Instructions and labelling must correspond to the registered or filed content. This supports controlled terminology; it does not mean an approved term can never be changed through the applicable procedure.
Keep approved product names and source references available for later revisions. Proposed changes should be assessed through the applicable regulatory process rather than silently carried forward or silently rewritten.
yjj.sh.gov.cn · retrieved 2026-10-11
The Provisions require the text of instructions for use and labelling to be in Chinese. Other languages may be added, but the Chinese governs — it is the operative version, not a courtesy translation.
yjj.sh.gov.cnImported device registration and filing involve national-level requirements, but the current receiving route, classification and any delegated arrangements should be confirmed for the product. Do not infer the competent authority from the location of a distributor.
www.nmpa.gov.cnThe 2004 provisions were expressly repealed in 2014 by the current Provisions on Medical Device Instructions for Use and Labelling. Industry commentary still circulates under the old title.
yjj.sh.gov.cnArticle 17 of SAMR Order No. 47 requires Chinese registration and filing material and the original when translated from a foreign language. Detailed dossier and attestation requirements must still be checked for the exact procedure.
www.samr.gov.cnChinese regulation distinguishes registration (注册) from filing (备案): Class I devices are subject to filing, Classes II and III to registration, and the two differ in review depth and legal effect. English material that merges them can send a company down the wrong procedure. Noted as an observation from practice rather than an official provision.
No public case naming a document or language problem as the stated cause was found. What follows is the regulatory position, recorded without predicting outcomes.
No public case citing document or language grounds was located; supplementation notices generally do not disclose the specific grounds.
Imported devices without the required Chinese labelling and packaging text may not be sold or used. No public case of goods held specifically over missing Chinese labelling was located.
yjj.sh.gov.cnThis research did not establish a product-specific enforcement case about translation or documentation. The authority portal alone does not prove a particular inspection or recall finding.
www.nmpa.gov.cnYes. Article 17 of SAMR Order No. 47 requires Chinese registration and filing material and the original where translated from foreign-language material. Confirm the detailed dossier and signature or seal requirements for the actual procedure.
Retrieved 2026-10-11
The NMPA publishes some English content, but the authoritative text of the governing Regulation and the departmental rules is Chinese. No official full English translation carrying legal effect was identified in this research, so English material should be treated as reference.
Retrieved 2026-08-26
Confirm the current imported-device class, registration or filing route and receiving authority. National rules and the actual submission procedure govern; a provincial distributor address does not establish the review authority.
Retrieved 2026-08-26
Check the certificate expiry, renewal or change procedure, approved product scope and rules that apply to the intended submission. A previous approval does not by itself establish that every document or source version can be reused unchanged.
Retrieved 2026-08-26
Do not infer a translation-agency stamp requirement from a general language clause. Confirm the applicable dossier annex, agent signature or seal rules and any translator declaration for the exact procedure. These attestation details were not revalidated in this review.
Retrieved 2026-08-26
Yes. Instructions and labelling content must agree with the registered or filed content, and the product name must match the registration certificate. Consistency across renewals and changes is a stated requirement, not a stylistic preference.
Retrieved 2026-08-26
The national laws and regulations database (flk.npc.gov.cn) shows a regulation's history and current status; NMPA pages carry issue and effective dates. Note that Chinese regulations often exist in several amended versions under the same title, so check the document number and amendment date.
Retrieved 2026-08-26
This page is a dated public-source research record, not a complete update bulletin. Confirm the current governing regulation, classification and dossier requirements for the specific product; the source dates below should not be read as a new verification of every later amendment.
Retrieved 2026-08-26
The following could not be established against an official source in this round, and so was not written into the findings above. It is listed so you can see where the research stops.
Retrieved 2026-08-26
Regulatory research is a separate service line. It is not a tier of the L1–L4 translation service levels.
This page presents regulatory research intended to help companies understand documentation requirements in a target market. It does not constitute legal advice and is not a substitute for qualified legal counsel.
All regulation numbers, effective dates, and status indicators on this page carry a source and a retrieval date. Regulations may change after that date. For determinations of legal effect, the official-language text and the current rules of the competent authority govern.
Before this material is used for filing, certification, or any external commitment, we recommend review by a licensed attorney in the target market.
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