Guide

Tender and registration files for medical products from China: documents, apostille and dossier

Last updated 26 September 2026

Sinospect supplies medical products from China with the manufacturer’s tender and registration documents gathered, checked and prepared for the destination. Send the tender’s document list →

This guide is for distributors and tender teams bidding Chinese-made medical products, and for buyers checking such bids. Sinospect checked the rules below at the issuing bodies on 26 September 2026.

The documents that come from China

Documents a Chinese medical manufacturer provides for a tender or registration file
Document	Issued by	What it proves	Where to check
Business licence	The manufacturer’s local market regulator	The legal entity, its unified social credit code and business scope	National Enterprise Credit Information Publicity System
Production licence (Class II and III) or production filing (Class I)	Provincial medical products administration (licence); city-level regulator (filing)	The site may make the product’s category; the licence is valid five years	NMPA data search; the provincial administration
NMPA registration certificate (Class II and III) or filing (Class I)	NMPA (Class III and imports); provincial administration (Class II); city-level regulator (Class I)	The product is registered or filed in China; the registration certificate is valid five years	NMPA data search
Export certificate (I) or (II)	Provincial medical products administration	(I) the product may be made and sold in China; (II) an export-only product from a licensed manufacturer whose production conditions meet China’s good manufacturing practice	The issuing province’s public list
ISO 13485 certificate	Certification body	The quality management system, for the scope written	IAF CertSearch or the CNCA platform
CE certificate and EU declaration of conformity	Notified body; manufacturer	Access to the EU market	EUDAMED and NANDO
FDA registration, listing and 510(k)	FDA database records	Access to the US market	FDA databases (the FDA issues no registration certificates)
Test reports and CB certificates	Test laboratories; CB testing laboratories	Conformity with the product standard	IECEE database for CB certificates
Manufacturer’s authorization	The manufacturer	The bidder may offer the goods	The signatory’s authority, on the company’s records
Labels, instructions for use, catalogue	The manufacturer	The product offered matches the specification	Against the tender’s technical specification

The checks behind each record are set out in how to verify a Chinese medical device manufacturer.

The certificate of free sale from China

When a tender asks for a certificate of free sale, the Chinese document that answers it is the NMPA export certificate, issued by the provincial medical products administration since 1 May 2026 under NMPA Announcement 2025 No. 126. Type (I) goes to the registrant of a device registered or filed in China; type (II) goes to the actual manufacturer of an export-only device and certifies production conditions that meet China’s good manufacturing practice.

The certificate expires with the earliest of the documents behind it, a Class I certificate lasts three years at most, and each province publishes the certificates it issues within seven working days. The Chinese number reads 药监械出 with the year and a six-digit serial; the English version reads No.MD, a two-letter province code, the year and the serial.

Authenticating Chinese documents: apostille or legalisation

Issued in China
Documents from an authority
Export certificate, NMPA registration certificate, production licence. Public documents: they can take the apostille at step 3.
Copies and private documents
Copy of the business licence, manufacturer’s authorization, declaration of conformity. They go to the notary first.
Notary
A Chinese notary certifies the copy or the signature. The notarial certificate is a public document.
Apostille or legalisation
Apostille
Ministry of Foreign Affairs, or an entrusted Foreign Affairs Office such as Zhejiang, Ningbo, Shanghai or Guangdong. For the other Apostille Convention states, India excepted.
Verify at consular.mfa.gov.cn/VERIFY/
Consular legalisation
Chinese foreign affairs authority, then the destination’s embassy or consulate. For India and for states outside the Convention.
Destination
The tender authority or the regulator receives the authenticated document.

Apostille Convention rules for China, in force since 7 November 2023; competent authorities as listed by the HCCH.

China acceded to the Apostille Convention on 8 March 2023, and the Convention has applied to Chinese public documents since 7 November 2023. India objected to the accession, so documents between China and India still go through consular legalisation, as do documents for states outside the Convention.

In mainland China, the Ministry of Foreign Affairs issues apostilles, and so do the Foreign Affairs Offices it has entrusted for documents from their own jurisdiction, among them Zhejiang, Ningbo, Shanghai, Jiangsu, Guangdong and Shenzhen. Hong Kong and Macao have their own competent authorities. Anyone can verify an apostille issued in mainland China on the Ministry’s website.

A document issued by an authority, such as an export certificate, is a public document that can take the apostille. A copy or a private document, such as a manufacturer’s authorization or a declaration of conformity, is first certified by a notary; the notarial certificate is a public document, and the apostille goes on it.

The manufacturer’s authorization and after-sales commitments

The World Bank’s Standard Procurement Document for goods (October 2017) sets out these forms. Where the bid data sheet requires it, a bidder other than the manufacturer submits the Manufacturer’s Authorization on the form in the bidding document, showing that the manufacturer authorises it to supply the goods in the purchaser’s country. Where required, a bidder from outside the purchaser’s country is represented there by an agent able to carry out maintenance, repair and spare-parts obligations, and the bid data sheet sets how long the goods are expected to function for spare-parts purposes.

Ask for the authorization on the tender’s own form, naming the tender, the products and the bidder, and signed by a person with authority to bind the manufacturer.

The registration dossier

Registration in the destination market rests on the manufacturer’s technical documentation, arranged in the structure the regulator uses:

European Union: MDR Annex II sets six sections: device description and specification, information supplied by the manufacturer, design and manufacturing information, general safety and performance requirements, benefit-risk analysis and risk management, and product verification and validation. Annex III adds the post-market surveillance documentation.
United States: since 1 October 2023, every 510(k) is submitted electronically with the FDA’s eSTAR template, unless exempted.
IMDRF Table of Contents: the harmonised structure for market authorisation submissions (non-IVD Edition 4), used by Health Canada among others.
WHO Global Model Regulatory Framework (2017): a model for national regulation that provides for reliance on other regulators’ decisions.

The supply agreement should oblige the manufacturer to provide this documentation to whoever registers the product in the destination, and to keep it current.

EU public tenders of EUR 5 million or more

Since 30 June 2025, tenders from Chinese economic operators are excluded from EU public procurement of medical devices worth EUR 5 million or more, and the winning tenderer may supply goods of Chinese origin up to 50% of the contract value (Implementing Regulation (EU) 2025/1197 and Regulation (EU) 2022/1031, Article 8). The guide to buying medical equipment from China sets out the details.

Checklist

The tender’s document list, read against the table above, with each document’s issuer and validity date.
The export certificate type, (I) or (II), found on the issuing province’s list.
The manufacturer’s authorization on the tender’s form, naming the tender, the products and the bidder.
The authentication route for the destination: apostille for Convention states, consular legalisation for India and non-member states, with each apostille checked online.
The dossier structure the destination uses, and the manufacturer’s obligation to provide and update the documentation, written into the supply agreement.
The after-sales terms the tender requires: local agent, spare-parts period and service scope.
For EU tenders of EUR 5 million or more: the origin rules of the procurement measure.

Frequently asked questions

What is a certificate of free sale for a Chinese medical device?

It is the NMPA export certificate, issued by the provincial medical products administration. Type (I) covers a device registered or filed in China; type (II) covers an export-only device from a licensed manufacturer whose production conditions meet China’s good manufacturing practice.

Do Chinese documents need legalisation or an apostille?

Since 7 November 2023, Chinese public documents take an apostille for use in the other Apostille Convention states, India excepted. Documents for India and for states outside the Convention go through consular legalisation. Apostilles issued in mainland China can be verified on the website of China’s Ministry of Foreign Affairs.

What is a manufacturer’s authorization in a medical tender?

A document on the tender’s form in which the manufacturer authorises the bidder to supply its goods in the purchaser’s country. The World Bank’s standard procurement document for goods requires it from a bidder other than the manufacturer, where the bid data sheet calls for it.

Which structure does a registration dossier follow?

The destination regulator’s: MDR Annex II in the EU, the FDA’s eSTAR template for a 510(k), the IMDRF Table of Contents in several other markets, or a national format. The content comes from the manufacturer’s technical documentation.

How Sinospect prepares the documents

Sinospect supplies medical products from China and gathers the manufacturer’s tender and registration documents for the order. It checks the licences, registrations and certificates in their public registers, reviews the other documents against the tender file, arranges notarisation and the apostille or legalisation in China, and writes the manufacturer’s obligation to provide and update the technical documentation into the supply agreement.

See also the guides to sterile medical disposables and medical equipment, and China supplier evaluation for a supplier you found yourself.

Preparing a medical tender with products from China?

Send the tender’s document list and the products. Sinospect replies with the documents each manufacturer can provide, the authentication route for the destination and the supply terms.

Send the tender’s document list Medical equipment sourcing

Sources

Checked at the issuing bodies on 26 September 2026.