Class II vs class III medical devices in China
China sorts medical devices into three risk classes. The class decides who approves a product, what its manufacturer must hold, and what the front of the certificate number looks like.
Three classes, sorted by risk
Chinese medical device law sorts devices into three classes by risk. Class I is the lowest risk, class II is moderate and class III is the highest.
The class is not a marketing tier. It decides the approval route, the documents the manufacturer must hold and the obligations that fall on anyone importing or selling the device.
Who approves what
Class I — filing
The lowest risk. Filed rather than registered, at municipal level.
Class II — provincial registration
Moderate risk. Registered, and for a device made in China the registering authority is the province, autonomous region or municipality.
Class III — national registration
The highest risk. Registered at national level.
The number shows the route
A domestic class II certificate opens with a province name. A domestic class III certificate opens with 国.
So the approving authority is not a detail you have to take on trust. It is written into the first character of the registration number.
The same rule, read from the number
A domestic class II certificate reads 陕械注准: the province abbreviation, then registration, then the domestic route. Segment four is the risk class, and on a class II certificate it is 2.
Replace that digit with 3, move the approving authority to national level, and you are looking at a class III certificate instead.
How to verify an NMPA registration number — The segment-by-segment breakdown is on the registration number page.
What the class changes for a manufacturer
Production licence
A site making class II or class III devices holds a production licence. A site making only class I devices files instead.
Renewal
A registration certificate is valid for five years and is renewed before it lapses. Renewal keeps the original number.
Change of class
If a product changes risk class, the certificate is renumbered rather than amended in place.
Quality system certificate
The class shapes how far the quality system is scrutinised, and against which standard the site is expected to operate.
What the class changes for a buyer
- Operating requirements in China. Selling class III devices in China requires an operating licence, selling class II devices requires a filing, and class I devices require neither.
- The documents you are handed. The class decides whether the product arrives with a registration certificate or a filing record, and which number you should expect to see.
- The name on the certificate. Registration is granted to one entity, and that entity is the one a regulator and a customs broker will look for.
The last of those three is where the money goes missing. A registration held by one company and a contract signed with another is a legitimate arrangement in itself, and a problem in a dispute.
Where the classification itself comes from
Classification is not decided case by case by the buyer or by the factory. The national classification catalogue assigns products to classes, and the catalogue is published.
A device that is genuinely new and appears in no entry can be submitted for a classification determination, or filed directly as class III. Manufacturers take that route when there is no existing entry to point at.
Both the catalogue and the classification determination route sit behind the medical device section of the National Medical Products Administration website.
Where to go next
- How to verify an NMPA registration number — Read the class out of the certificate number, segment by segment.
- Certifications — See the class II registrations this site holds, as filed.
- Catalogue — See the products behind those registration numbers.
- Market Access — Understand what your own market will require before the goods arrive.
