EU Authorized Representative for Chinese Medical Device Manufacturers: From NMPA to MDR
China holds a five-year NMPA registration certificate system built on a national classification catalogue, and none of it crosses into the Union. The gap matters more here than almost anywhere else, because Chinese plants supply so much of Europe's disposable and PPE volume through the MDR Class I self-declaration route, and because the question of who legally owns the CE mark is rarely settled when a Chinese factory builds for a European brand. This page deals with those three problems in order: what the certificate is not, where the classification actually comes from, and whose name belongs on the label.
What an NMPA registration certificate actually certifies
A registration certificate issued under the Regulations for the Supervision and Administration of Medical Devices (State Council Order No. 739) is permission to market a named product in China, held by a named registrant and valid for five years. It follows a review by NMPA or a provincial drug regulatory department of a dossier filed in Chinese, against Chinese technical requirements, with clinical evaluation under Chinese rules.
None of that is a conformity assessment under Regulation (EU) 2017/745. The Union does not recognise the certificate and does not treat NMPA's review as evidence that the general safety and performance requirements in Annex I have been met. A device sold in China for a decade starts the European route on the same line as one never sold anywhere.
Two catalogues, two classifications, no bridge between them
China classifies by catalogue: the Rules for Classification of Medical Devices set out risk factors, and the Medical Device Classification Catalogue then assigns a class to a named product family. You look your product up. The EU does the opposite — Annex VIII contains twenty-two rules that you apply yourself to your own intended purpose. There is no European catalogue and no authority that will assign your class for you.
This is where Chinese files go wrong earliest. A wound dressing sitting comfortably in a Chinese catalogue entry has to be tested against MDR Rule 4, which splits non-invasive devices contacting injured skin four ways depending on whether the product is a mechanical barrier, manages the micro-environment, or is intended principally for injuries that have breached the dermis. Three of those four outcomes need a notified body, and the catalogue entry tells you nothing about which applies.
| Chinese instrument | What it establishes in China | What it establishes in the Union |
|---|---|---|
| Class I filing (record) number | Product may be manufactured and sold; filing made to city-level or, for imports, national level | Nothing. MDR class is decided by Annex VIII rules, not by the Chinese filing |
| Class II / Class III registration certificate | Five-year marketing authorisation held by the registrant | Nothing. No presumption of conformity, no substitute for Annex IX or Annex X/XI |
| Registrant status under Order No. 739 | Lifecycle quality responsibility for the registered product | Not a role the MDR recognises. The MDR asks who the manufacturer, importer and authorised representative are |
| Production licence and Chinese GMP inspection | Site is authorised to manufacture | Useful background for an auditor, but the notified body audits against its own criteria and ISO 13485 |
| Chinese-language technical dossier | Accepted as filed | Must be rebuilt to Annex II and Annex III structure in a language the notified body accepts |
Class I self-declaration: the most expensive shortcut in a Chinese export file
Chinese plants supply much of Europe's disposables — gloves, masks, syringes, dressings — and of the subassemblies inside imaging equipment. Much of that volume is declared into Europe as MDR Class I, self-certified, CE mark applied by the manufacturer alone. Article 52(7) allows it: a Class I manufacturer declares conformity by issuing the EU declaration of conformity after drawing up the technical documentation in Annexes II and III. The trap sits in the same paragraph. If the device is placed on the market in sterile condition, has a measuring function or is a reusable surgical instrument, a notified body must still be involved, limited to sterility, metrology or reprocessing respectively.
So a sterile syringe is not a self-certified device, nor is a sterile dressing, nor a reusable surgical instrument. Market surveillance authorities know which families are pushed through the Class I door, and an unsupported declaration collapses the file: the CE mark comes off, stock is detained, and the authorised representative is the address the authority writes to.
Getting the class right before anything is printed is cheaper. Our published class-based fees exist partly so that the class conversation happens at the start rather than after a detention notice.
Whose name goes on the label when the plant is in Shenzhen and the brand is in Milan
This is the single most consequential question for Chinese contract manufacturers, and it is answered by definition rather than by contract. The MDR defines the role: "'manufacturer' means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mar" (MDR Art. 2(30)).
Making the device is not what makes you the manufacturer; marketing it under your name or trademark is. If a European buyer puts its own brand on your product, that buyer is the manufacturer and needs no authorised representative, being established in the Union. Article 16(1) confirms the mirror image: a distributor or importer assumes manufacturer obligations if it "makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation" (MDR Art. 16(1)(a)).
Two different businesses follow from that sentence. If your Chinese company keeps its name on the label, it is the manufacturer, it needs a sole EU Authorized Representative, and it carries the liability. If the European brand owner takes the label, you become its supplier and your obligation is contractual rather than regulatory. Decide this deliberately: exporters routinely discover they were the legal manufacturer of a device sold under someone else's brand only when a vigilance case arrives.
A dossier written in Chinese meets an audit conducted in English
Registration documents in China are filed in Chinese, with the foreign-language original attached where the text was translated. The MDR reverses that burden and multiplies it. The Member State where your notified body is established may require the technical documentation, audit and assessment reports in an official Union language it determines; failing that, they must be in a Union language the notified body accepts (MDR Art. 52(12)). The EU declaration of conformity must be translated into the languages required by every Member State where the device is made available (MDR Art. 19(1)), and Article 10(11) requires the Annex I Section 23 information to accompany the device in the language of the country of use.
For a Chinese exporter selling into eight or ten Member States this is not a translation line item but a controlled-document problem: every instruction for use, label and declaration exists in a dozen versions, each kept current inside the quality management system and reproducible on request years later.
Registering the actors before a notified body will open a file
Article 31 requires manufacturers, authorised representatives and importers to register in EUDAMED and obtain a single registration number, and Article 31(3) makes that SRN the key the manufacturer uses when applying to a notified body. The sequence is: appoint the representative, sign the mandate, register the actors, get the SRN, then approach the notified body. Manufacturers who reverse it lose weeks.
The first four EUDAMED modules — actor registration, UDI/device registration, notified bodies and certificates, and market surveillance — became mandatory on 28 May 2026 following Commission Decision (EU) 2025/2371. Our EUDAMED registration service covers actor and device entry, including Basic UDI-DI assignment for portfolios that were never structured for UDI.
Questions Chinese manufacturers put to us first
We hold an NMPA Class III certificate. Does that shorten the MDR route at all?
Not formally: no article of the MDR gives weight to a third-country approval. It does prove that clinical and performance data exist somewhere in your organisation, which shortens the work of assembling an Annex II file. The data must be re-evaluated against Annex XIV, not simply re-filed.
Our European customer says it will handle CE marking. Do we still need a representative?
If that customer genuinely puts its own name or trademark on the device and takes the manufacturer role, you do not — there is no non-EU manufacturer to represent. Get it in writing and check the label: if your brand appears on the device, packaging or instructions for use, Article 11 applies to you whatever the purchase agreement says.
Can we keep our devices in Class I and avoid a notified body?
Only if Annex VIII genuinely places them there and none of the three conditions in Article 52(7) applies. We assess this against your actual intended purpose wording, because intended purpose, not product type, drives the rule.
How does a Chinese manufacturer answer a competent authority request from Europe?
Through the representative. Article 11(3)(d) puts the duty to supply information demonstrating conformity, in an official Union language determined by the Member State concerned, on the authorised representative — so the file has to be held in Europe and usable there, not on a server in Guangdong waiting for a translator. Talk to us at our regulatory desk before an authority asks rather than after.