How to choose a medical device OEM in China
Choosing a contract manufacturer for a class II device is a document exercise before it is a factory visit. Three roles sit behind one quotation, and most of the risk lives in which one you are actually talking to.
What you are actually selecting
A quotation for a class II medical device usually arrives from one company, but the work is split across three. The registration certificate is held by one legal entity. The manufacturing site named on that certificate may be a second. The company that signs your contract and issues the invoice may be a third. In a small factory these three collapse into one company, and in a trading arrangement they do not.
None of those arrangements is automatically wrong. A distributor that holds registrations and subcontracts production is a normal structure. What is wrong is not knowing which one you bought, because liability, batch traceability and the ability to change a specification all follow the entity that holds the certificate, not the one that answers your email.
Four questions that decide the shortlist
Who is named as the manufacturer on the certificate
A registration certificate carries both a holder and a manufacturing address. Ask for a copy and read the address field, not the letterhead. If the address is a different company in a different province, you are buying from a trader, and the factory has never agreed to your order.
Does the production licence cover your category
A production licence lists permitted categories, and medical devices and cosmetics are licensed separately. One site can hold both, on two documents. A licence for dressings does not cover a gel, and a cosmetics licence is not a device qualification.
Is your product registered, or only a neighbour
Suppliers often show a valid certificate for a product in the same family and let you assume it covers yours. Check the product name and the specification on the certificate against the item in your purchase order. A registered sister product is not a registration for your variant.
Who signs the contract
The contracting entity should be the one that can be held to the specification, which in practice means the certificate holder or the licensed manufacturer. If a third company signs, ask in writing who is responsible for the batch you receive and where a claim would be filed.
Where a trader and a manufacturer visibly diverge
Three things are hard to fake, and all three are cheap to ask for. They are worth more than a video call tour of a production hall.
- A batch certificate of analysis for a recent lot, with the lot number still traceable to a production record. A trader can forward a certificate from the factory; a manufacturer can show which line it came off.
- A change you ask for, and the answer. Formulation, format, fill volume, packaging and labelling are all line-level decisions. A trader has to go and ask someone; a manufacturer answers with what the line can and cannot do, and what it costs.
- An audit that is accepted or refused in writing. If a second-party audit is refused without a stated reason, or offered only as a paid service through a third party, that is information about the arrangement, not about the factory.
A fourth difference shows up later, at the first quality complaint. A registered manufacturer can open a non-conformance against its own batch record. A trader can only relay your complaint, and the answer you get back has been through someone whose name is not on any document you hold.
What we do, and what we decline
It is easier to judge a shortlist when one candidate states its own boundary. This site manufactures class II medical devices in the dressing and gel categories and special-use cosmetics, and holds 25 class II registrations. Sixteen of those certificate numbers are listed on this site against the products they cover; the rest are held but not shown here, so a buyer can count what is published rather than take a total on trust.
We do not take class III devices, injectables, or any product that would need a route we do not hold. And we do not register your product in your own market: that filing belongs to your regulatory affairs team or your local agent, and a supplier who offers to handle it is usually reselling someone else's service. What we provide is the manufacturing and Chinese registration side, plus the documents your agent will ask for.
Send this before the first call
- The product name and specification you want, in the same words you will use on the purchase order.
- The destination market, because the export document set depends on it and some markets add requirements at the border.
- The annual volume and the first order volume separately. They are different questions and they get different answers.
- Whether you want your own brand on the label, and who owns the artwork.
- Whether you will need the technical file for a regulatory submission in your market.
The answers you get back will sort the shortlist faster than any ranking. A supplier who answers questions one, two and five with documents is a different kind of counterparty from one who answers with a price list.
Where to go next
- Medical device manufacturing in China — The category range, the licence position and the five steps from enquiry to first order.
- Certifications — The licences and registrations held by this site, with the numbers as filed.
- How to verify an NMPA registration number — Read the number on the certificate before you accept the quotation.
- What documents your Chinese supplier must provide — The full document set, and the question each one answers.
