Contract manufacturing of Class II medical devices in China
Sichuan Wanyaoda Technology Co., Ltd. is the legal entity behind YIMEI, a Class II medical device manufacturer in Chengdu, China. The site holds a medical device production licence and twenty-five Class II NMPA registrations. This page is written for buyers who will have to defend the choice of supplier to their own regulator, auditor or customer, so it states what can be checked and what we do not claim.
What this site manufactures
The registered range is wound care and skin repair: dressings, gels, ointments, liquid dressings and one gynaecological gel. Every item is made at the same Chengdu site, under the same quality system.
- Sterile dressings — hydrogel and collagen dressings in sterile packaging, in the pack formats listed in the catalogue.
- Gels and ointments — ectoin and chitosan gels, filled inside the ISO 7 cleanroom.
- Liquid dressings and sprays — multi-dose liquid formats, including 100 ml spray and 30 ml presentations.
- One special-use cosmetic — a whitening and freckle-removing product registered under the cosmetics route, not the device route.
We do not present a catalogue of unrelated products. If an item is not on the registered list, we do not offer it as a registered device. The full list, with registration numbers, pack formats and registered indications, is in the catalogue.
The evidence, and how to check it
Most supplier pages list certifications. Fewer explain what each one proves and where it can be verified. These are the four items that matter for a Class II order, in the order a regulatory reviewer usually asks for them.
1. Medical device production licence
A Chinese medical device production licence is a separate licence from a cosmetics licence, with its own site, quality-system and personnel requirements. It is issued for a specific site and a specific production scope. Ask for the licence number, and compare the scope with what you are buying.
2. NMPA Class II registrations
Twenty-five Class II registrations are held in total. Sixteen of them are listed with their numbers in the catalogue; the rest cover items not published there. A registration number is public: it can be looked up in the NMPA database and matched against the manufacturer name, the product name and the registered indications.
How an NMPA registration number is built and where to check it
3. ISO 13485 quality system
Our medical device quality system is certified to ISO 13485, and the certificate is available on request. Check that it is current and that it names the manufacturing site. A group certificate that lists a sales office proves much less than one that names the factory you will be audited at.
4. Cleanroom class and floor area
Bulk manufacture, filling and sterile handling take place in a 4,000 m² ISO 7 (GMP) cleanroom, within 15,000 m² of production area. The cleanroom class is stated in the technical file, and it is one of the first things a testing laboratory will ask about.
From first enquiry to first shipment
This is the sequence we actually run. Times are not fixed here because they depend on the item, the packaging and the destination, but the order of the steps does not change.
- Brief — item, pack format, quantity, destination market and label language. If you have a target price, state it at this point rather than after the quotation.
- Quotation and specification — we confirm what is being quoted: item, pack format, quantity, Incoterm and currency. The specification sheet states the registered indications, materials and shelf life.
- Samples — from the existing range, or development work if the brief needs a new formulation. Sample and courier costs are confirmed before anything ships.
- Documentation — registration certificate, production licence, ISO 13485 certificate, technical file and batch records as your market requires. Tell us early which documents your authority will ask for.
- Production and shipment — production is scheduled against the confirmed order. Export documents are the commercial invoice, packing list and bill of lading or air waybill; certificate of analysis and certificate of origin are issued on request.
The step that most often delays a first order is not production. It is documentation requested late, or a label artwork that had to be redesigned after the claims were approved.
Why the minimum order is 10,000 boxes per item
10,000 boxes per item is a manufacturing constraint, not a negotiating position. A production run carries fixed costs: line set-up, cleaning and changeover, packaging components, and the batch records that have to be opened and closed. Below a certain volume those costs are spread over too few units for a batch to be worth running.
It applies to first orders as well. We would rather say that at the beginning than have you discover it after weeks of correspondence. If your launch volume sits below the minimum, the practical routes are to launch with fewer items at the full quantity, or to start from the existing registered range instead of a new formulation.
Packaging is confirmed per project. Cartons, labels and artwork are sourced against your brief, so the available options and any tooling are confirmed before you commit.
Export markets and registration routes
A Chinese registration lets us manufacture and export. It does not by itself let you sell in your market. Placing a device on a foreign shelf is a separate approval, and usually the slowest part of a project.
For the EAEU we prepare the technical files and work with your authorised representative inside the union, because a foreign manufacturer cannot file in its own name. For other markets we supply the dossiers your regulatory agent needs and answer their technical questions directly.
Registration and market access support · Certifications held by this site
Six problems that surface after the order is placed
Each of these is common enough to be worth checking before you commit. They are written from the buyer's side, not ours.
- The supplier is a trader, not the manufacturer — if the registration certificate names a different company from the one quoting you, you are buying through an intermediary. That is not automatically wrong, but the audit trail and the accountability are different.
- The registration number is real but does not cover the item — a number can exist and still not apply to the product you are buying. Check the product name and the registered indications, not just that a certificate exists.
- The documents arrive after the order — the set your authority needs is decided by your market, not by the supplier, and asking for it late pushes the launch back.
- The device class was assumed, not checked — Class II and Class III follow different approval routes in China, and the class decides who signs the certificate.
- Export was confused with market access — being able to ship from China is not the same as being allowed to sell where the goods land.
- The label was designed before the claims were approved — artwork built on wording that later changes is the most expensive kind of reprint.
Read more: How to evaluate a Chinese OEM skincare factory · What documents your Chinese supplier must provide · Class II vs class III medical devices in China · How to import class II medical devices from China
What to send us
Item or product type, pack format, quantity, destination market, and the documents your authority requires. If you already have a label artwork or a specification, send it — it shortens the first exchange. We correspond in English, Russian, Kazakh, Chinese, Spanish and Arabic.
Tell us what your market needs
Send us your requirements and we will reply with a catalogue, pricing and realistic lead times — usually within one business day.
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