Short answer: in China, Class I devices are lower-risk and filed with the authority, while Class II devices need a registration certificate. For a buyer the category is useful evidence of what the product is and how it is regulated at the source, but it does not authorize sale in another country. The importer still registers or notifies the product locally.
The two categories in our range
| Category | Examples from our catalog |
|---|---|
| Class I (filing) | 0.9% saline cleansing solution, fever cooling patch, cotton swabs, examination gloves, finger cots, surgical instruments |
| Class II (registration) | seawater nasal spray, anti-snoring spray, anti-allergy nasal gel, scar repair gel, oral ulcer rinse, liquid dressing, gynecological gel, hemorrhoid gel dressing, far-infrared therapy patch |
What the category tells you
- The intended use is defined. A registered device has a stated intended use. On our product pages that is what we quote, for example “helps improve pathological scars and helps prevent their formation; not for unhealed wounds” for the scar gel.
- Production is under a device quality system. Devices are made under the manufacturer’s device production license; ours are produced in Class 100,000 cleanroom workshops.
- Documentation exists. A registered product has technical documentation the manufacturer can draw on to support your local registration.
What it does not tell you
- It is not a license to sell abroad. Each market has its own classification and process; the same product may sit in a different class there.
- Claims do not travel automatically. Write claims that match your local approval, not the Chinese label.
- It does not cover your packaging. Private-label artwork and leaflets must meet your local labeling rules.
How to use it when sourcing
- Ask for the Chinese registration category and certificate copy with the quotation.
- Ask your regulatory contact which class the product falls into in your market and what they need from the manufacturer.
- Agree on the documents the factory will provide before ordering samples.
- Only then finalize claims and artwork.
See Quality & Registrations for all registration categories in our range, including disinfection and cosmetic filings.
Request a quote
To get a useful quotation in one round, send us:
- The product (a link to our catalog is fine) and the size or volume
- Estimated quantity per order and per year
- Bare product, retail box or full private label
- Your target market and the documents your importer or regulator asks for
