Guide

How to verify a Chinese medical device manufacturer: licences, registrations and certificates

Last updated 26 September 2026

Sinospect checks Chinese medical manufacturers against these registers, in Chinese, before a buyer orders or pays. Send the supplier’s documents →

This guide is for a buyer holding a quote from a Chinese medical device manufacturer or a trader. Sinospect checked the rules below at the issuing bodies on 26 September 2026.

The five records to line up

When one company registers and makes the product, one name and one address run through every record. Under contract manufacturing, the registration names the registrant and the production licence names the factory, and the production address links the two.

The records that identify a Chinese medical device manufacturer, and where to check each one
Record	Issued by	Where to check	What must match
Business licence	The local market regulator	National Enterprise Credit Information Publicity System	The Chinese legal name, unified social credit code and status of the factory, and of the registrant when it is a different company; the factory’s business scope includes medical device production
Production licence (Class II and III) or production filing (Class I)	Provincial medical products administration (licence); city-level regulator (filing)	NMPA data search; the provincial administration’s site	The factory’s name, credit code and domicile, identical to its business licence; the production address; a production scope covering the product’s category
Product registration (Class II and III) or filing (Class I)	NMPA (Class III and imports); provincial administration (Class II); city-level regulator (Class I)	NMPA data search	The registrant; a production address that matches the factory’s licence; the product name, models and validity date
ISO 13485, CE and FDA records	Certification body; EU notified body; FDA	IAF CertSearch or the CNCA platform; EUDAMED and NANDO; FDA registration and listing, 510(k) database	Where the destination market requires them: the certified organisation, legal manufacturer or registered establishment is the registrant or the factory, and the scope covers the product
Export certificate (I) or (II)	Provincial medical products administration	The issuing province’s public list	Certificate (I) names the registrant and (II) the factory; the type, the name and a current validity date

Reading the numbers on Chinese medical documents

Every number on these documents follows a format set by regulation, so a buyer can read it before searching it.

Registration certificate, Class II and III

SAMR Order No. 47, Article 115

As printed: 浙械注准2023214××××

浙Authority
械注Registration
准Domestic
2023First registered
2Class
14Subcategory
××××Serial

A Class II device in subcategory 14, registered by Zhejiang in 2023. 国 in first place means the NMPA registered it: a Class III device made in China, or an import marked 进. A renewal keeps the year and the serial.

Filing, Class I

SAMR Order No. 47, Article 116

As printed: 浙甬械备2023××××

浙甬Province and city
械备Class I filing
2023Year
××××Serial

A filing marks a Class I product. Sterile products are at least Class II and carry a registration (械注).

Production licence

SAMR Order No. 53 and its 2022 implementing notices

As printed: 浙药监械生产许2023××××号

浙Province
药监械生产许Production licence
2023Year
××××Serial
号No.

Valid five years, with the same name and credit code as the business licence. Licences from before May 2022 read 食药监械生产许 with the same digits.

Export certificate

NMPA Announcement 2025 No. 126, Article 6

As printed: 浙药监械出2026××××××号

浙Province
药监械出Export certificate
2026Year
××××××Serial
号No.

The English version reads No.MD, a two-letter province code, the year and the serial. Type (I) or (II) is printed on the certificate.

Each format is set by regulation. The examples use Zhejiang (浙) and Ningbo (甬); the serial is left open as the regulations write it.

A sterile device is at least Class II in China (classification rules, Article 6), so its number carries 械注; a sterile product quoted with a 械备 filing number is inconsistent. The subcategory shows what the product was registered as: 14 covers injection, nursing and protective devices such as syringes, infusion sets and drapes; 10 covers transfusion, dialysis and extracorporeal circulation, including blood bags.

The company behind the name

The legal identity of a Chinese company is its Chinese name and its 18-character unified social credit code; the English name on a quote is a translation. Search either in the National Enterprise Credit Information Publicity System, which shows the registered name, legal representative, registered capital, business scope and status. Characters 3 to 8 of the code are the administrative division code of the registering authority, so the code itself shows where the company was registered (GB 32100-2015).

The production licence repeats the company name, credit code, legal representative and domicile, and the regulation requires them to match the business licence (Order No. 53, Article 14). The licence is valid for five years and also states the production address and production scope.

Who actually makes the product

Since 2021, China has used a registrant system: the company holding a registration certificate can contract production to another licensed manufacturer and remains responsible for releasing the product (Order No. 53, Articles 32 and 34). The registration certificate shows the production address, and the production licence shows which company operates there. The factory a buyer visits or audits should be at that address.

A device counts as registered only when it matches the certificate and its annex and was made while the certificate was valid (Order No. 47, Article 112). Check the model and specification on the quote against the certificate annex, and the production date against the validity date. Registration certificates are valid for five years.

ISO 13485, CE and FDA records

ISO 13485. Search the certificate on IAF CertSearch or, for a Chinese certification body, on the CNCA public platform. Check the scope wording, the site address, the accreditation body and the expiry date.

CE marking. A device in Class IIa or above, and a Class I device that is sterile, measuring or a reusable surgical instrument, needs a certificate from a notified body designated under Regulation (EU) 2017/745. The certificate appears in EUDAMED with its status, and the body appears in NANDO under that regulation; certificates issued under the former directives remain usable under the conditions of Regulation (EU) 2023/607. Any other Class I device carries CE marking on the manufacturer’s EU declaration of conformity, and a “CE certificate” from a test laboratory for such a device is a voluntary document.

FDA. The FDA publishes registrations and device listings in its own database and issues no registration certificates. Its China Office reported in 2021 that misleading “FDA registration certificates” were circulating through supply chains. Check the establishment in the FDA database and the clearance in the 510(k) database. The 510(k) holder may be a US company; the device listing links the Chinese site to that 510(k) number.

Export certificates (I) and (II)

Since 1 May 2026, provincial medical products administrations have issued two export certificates (NMPA Announcement 2025 No. 126):

Certificate (I) is issued to the registrant for a device registered or filed in China, and certifies that the product may be made and sold in China. The production address on the licence must match the one on the registration.
Certificate (II) is issued to the actual manufacturer for a device regulated as a medical device in China and made for export only. It certifies that the manufacturer’s production conditions meet China’s good manufacturing practice, and the application shows that its licence covers the product’s category.

A certificate expires with the earliest of the documents behind it, and a Class I certificate lasts three years at most. Each province publishes the certificates it issues within seven working days and voids any obtained with false documents.

When a trading company quotes

A trading company can supply registered products. Its quote should name the registrant and the manufacturer, and the checks above then apply to those two companies. The trader’s own business licence confirms who signs the contract and receives the payment. For the wider method, see manufacturer or trading company.

Checklist

The Chinese legal name and unified social credit code, found in the National Enterprise Credit Information Publicity System, with a status in business.
The factory’s production licence or filing: the same name and code as its business licence, the production address and a scope covering the product’s category.
The registration certificate or filing: the registrant, a production address that matches the factory’s licence, the models on the quote and a validity date after the production date.
The number formats: authority, class and subcategory consistent with the product and its claims.
The records the destination market requires: ISO 13485 on IAF CertSearch or the CNCA platform, the CE certificate in EUDAMED with the body in NANDO, and the FDA establishment and 510(k) records in the FDA databases.
The export certificate type, (I) or (II), found on the issuing province’s list.
For a trader’s quote: the registrant and manufacturer it names, checked as above.

Frequently asked questions

How do I check a Chinese medical device registration number?

Search it in the NMPA data search, which covers domestic and imported registrations and filings. Read the number first: the prefix gives the registering authority, the digits give the year of first registration, the class and the catalogue subcategory. The record then shows the registrant, the production address, the models and the validity date.

Does the FDA issue registration certificates to Chinese manufacturers?

The FDA publishes registrations and device listings in its database and issues no registration certificates. A document titled “FDA registration certificate” comes from a private company; the FDA database is the record to check.

What does a Chinese export certificate (II) prove?

It proves that the product is regulated as a medical device in China, is made for export only, and comes from a manufacturer whose licence covers its category and whose production conditions meet China’s good manufacturing practice. Any review of the product itself happens in the destination market.

Can a Chinese factory make a device registered by another company?

Yes. Under China’s registrant system, the registration holder can contract production to a licensed manufacturer and stays responsible for release. The registration certificate shows the production address, and the production licence shows the company operating there.

How Sinospect checks a Chinese medical manufacturer

Sinospect checks the five records in the Chinese registers, reads the numbers and compares every name, code and address with the quote. It cross-checks the offer against 1688, China’s domestic wholesale platform, to find the manufacturer behind a trader’s listing. The report states what matches and what the supplier still needs to answer, with video verification or a factory audit as the next step.

See China supplier evaluation and supplier due diligence before you pay; for supply, see medical equipment sourcing and the guides to sterile medical disposables from China and buying medical equipment from China.

Checking a Chinese medical manufacturer?

Send the supplier’s name, the quote and the documents it sent. Sinospect checks them against the Chinese, EU and US registers and reports what matches and what needs an answer before you order or pay.

Send the supplier’s documents China supplier evaluation

Sources

Checked at the issuing bodies on 26 September 2026.