Registration material submitted to the NMPA must be in Chinese: all documents other than certificating documents are provided in Chinese, and foreign-language certificating documents require a Chinese translation signed and sealed by the agent. Instructions for use and labelling must carry Chinese text — other languages may be added, but the Chinese version governs. (Retrieved 2026-08-26)
Findings on this page are pending verification against the official Chinese text by a reviewer with Chinese regulatory reading capability. Confirm against the source before relying on them.
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 | All items other than certificating documents are provided in Chinese. Foreign-language certificating documents require a Chinese translation signed and sealed by the agent; where the dossier is translated from foreign-language material, the original must be supplied alongside it. Whether the translation additionally requires a translation agency stamp or declaration could not be confirmed. | NMPA Announcement No. 121 of 2021, on registration dossier requirements and approval document formats | www.nmpa.gov.cn2026-08-26 |
| 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 | www.nmpa.gov.cn2026-08-26 |
| 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 | www.nmpa.gov.cn2026-08-26 |
| Technical documentation and test reports | Required | Chinese is required as part of the registration dossier; the foreign-language original must be supplied alongside the translation. Stamp or declaration requirements for the translation could not be confirmed. | NMPA Announcement No. 121 of 2021 | www.nmpa.gov.cn2026-08-26 |
| Clinical evaluation material | Required | Chinese is required as part of the registration dossier; originals are supplied alongside. Stamp or declaration requirements for the translation could not be confirmed. | NMPA Announcement No. 121 of 2021 | www.nmpa.gov.cn2026-08-26 |
| 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.cn2026-08-26 |
| Adverse event reports and recall documentation | To verify | Reports submitted to Chinese regulators are in Chinese. The specific language provision could not be located in this research. Carried as open — see gaps. | Measures for Medical Device Adverse Event Monitoring and Re-evaluation | www.nmpa.gov.cn2026-08-26 |
Chinese terminology used in later submissions is required to stay consistent with what was already approved.
A term chosen in the first submission is carried forward into renewals, changes and re-registration. Deciding it once, and recording why, is cheaper than reconciling divergent terms across a certificate's lifetime.
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.
www.nmpa.gov.cnRegistration and filing of imported devices — of every class — sit with the NMPA. Provincial administrations review Class II devices manufactured domestically. This is the distinction overseas companies most often get wrong.
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.
www.nmpa.gov.cnItems other than certificating documents are provided in Chinese. Originals may accompany the Chinese, but a Chinese version is required.
www.nmpa.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.
www.nmpa.gov.cnThe NMPA has run dedicated inspections of instructions, labelling and packaging text, with use of Chinese among the items checked. No public recall attributed to a language or documentation problem was located.
www.nmpa.gov.cnYes. Items other than certificating documents are provided in Chinese; foreign-language certificating documents require a Chinese translation signed and sealed by the agent, with the original supplied alongside.
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.
For imported devices of any class, the NMPA. Provincial administrations review Class II devices manufactured within China; Class I domestic devices are filed at municipal level.
Registration certificates carry a validity period and require renewal before expiry. Separately, the governing Regulation was amended in December 2024 with effect from 20 January 2025; certificates remain valid within their term, while items touched by the new requirements may need adjustment. Transitional detail was not established in this research.
The current requirement names signature and seal by the agent. Whether a translation agency stamp or declaration is additionally required could not be confirmed against an official source, and is listed as an open item.
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.
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.
The governing Regulation was amended on 6 December 2024 (State Council Order No. 797), effective 20 January 2025. In December 2025 the NMPA adjusted the classification category of 31 product types. The language requirements themselves — Chinese as the operative text — did not change fundamentally.
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.
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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