What documents your Chinese supplier must provide
Every document answers one question. Ask for the right set, and read each one for what it actually proves.
Start with the two questions
Every document a supplier sends you answers one of two questions: who this company is, or what this product is. A file that answers neither is a brochure.
This page sets out the document set a buyer should hold before a purchase order is signed. Not every item applies to every product, but the reason for each one does.
Documents about the entity and the site
Business licence
Which legal entity exists, under what registered name, with what registered scope of business and at which registered address.
Production licence
Which device categories this site may manufacture. It is issued to the site and it carries a scope that can be read.
Cosmetics production licence
The same idea for cosmetics, which are licensed separately from medical devices.
Quality system certificate
Whether an independent body has audited the quality system, and against which standard, such as ISO 13485 for medical devices.
One site can hold more than one production licence, because devices and cosmetics are licensed separately. Our own site holds both, and both are listed on the certifications page.
Documents about the product
Product registration certificate
That a class II or class III device has been registered, under which number, and by whom.
Device filing record
That a class I device has been filed rather than registered. The document is different and so is the numbering.
Special-use cosmetics registration
That a cosmetic in a regulated category holds its own approval. It is not a device registration and should not be presented as one.
Patent certificate
That a patent exists. It is not a marketing authorisation and it does not by itself permit a device to be sold.
These four are not interchangeable, and the failure mode is presentation: a cosmetics approval offered as if it covered a device, or a patent offered as if it were a licence. Match the document type to the product category you are actually buying.
Documents about the batch and the shipment
Batch certificate of analysis
That a named batch was tested, and against which specifications. Read the batch number against the goods when they arrive.
Free-sale certificate and certificate of origin
That the product may be sold in its country of origin. Some destination markets ask for it; others do not.
Safety data sheet
How the material is classified and handled in transport. A logistics document rather than a marketing one.
Batch record
The production record behind the certificate of analysis. Ask whether it is available at all, and under what conditions.
Ask which of these are issued per shipment and which are issued once. A batch record that predates your production run is a document about a different batch.
Documents about the formulation
The technical file and the formulation data are the documents your own laboratory and your own regulator will work from. They are also the documents a manufacturer is least willing to send into the open.
Ask for them under a confidentiality agreement, and expect the supplier to want one. That is a normal trade, not an obstruction.
Then decide, before the file changes hands, who is permitted to receive it. A file you cannot pass to your regulator is of limited use to you.
How to check the set against itself
- Compare the company name across every document, and ask for an explanation where the entity on the invoice differs from the one on the licence.
- Compare the addresses. A registered address and a production address are often different, which is normal. An address that appears on no document at all is not.
- Compare the product name and specification against the registration certificate, character by character.
- Look the registration number up on the national authority enquiry system rather than trusting a scan.
- Check the validity dates on the licences as well as on the registration certificate.
A document set is a system. The individual documents can all be genuine and still describe three different companies, two different products and a site that never made the goods.
What none of this proves
No document in this list proves that the batch you receive was made to specification. That is settled by testing, in your own laboratory, against a specification you agreed.
Nor does any of it prove that the certificate holder and your counterparty are the same company. Certificates are held by legal entities and contracts are signed by legal entities, and the two are allowed to differ.
The document set narrows the question. It does not answer it.
Where to go next
- How to verify an NMPA registration number — Learn how to read and check the one number the rest of the set has to agree with.
- How to evaluate a Chinese OEM skincare factory — See the sequence we follow when vetting a site, and what each step is meant to settle.
- Certifications — See this site's own document set, with certificate numbers as filed.
- Market Access — Understand what your own market will require, and which of these documents it will ask for.
