Registration and market access support
We can manufacture and export from China. Placing a product legally on your market's shelf is a separate step, and it is usually the slowest part of a project. Here is how we work with your regulatory team on the routes our buyers ask about most.
EAEU (EAC) — Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan
One registration system covers all five member states, but the procedure depends on what the product is.
Cosmetics
Most cosmetics go to market on an EAC declaration of conformity. A small number of high-risk categories — children's products, whitening and peeling products, depilatories and products containing nanomaterials — need state registration instead.
A foreign manufacturer cannot file in its own name. The applicant must be a legal entity established inside the union, so an importer, distributor or appointed authorised representative files on your behalf.
Medical devices
Medical devices follow a separate EAEU registration route rather than the cosmetics regulation, and each device is registered in its own right. A legal entity inside the union is required here as well.
What we supply
- Product technical files and formulation data, in the form a testing laboratory needs.
- GMP evidence and the documentation that supports our manufacturing site.
- Russian and Kazakh label artwork built on the claims you approve.
- Direct answers to technical questions from your representative, your laboratory or the authority.
ISO 13485, CE and other quality schemes
ISO 13485
Yes. Our medical device quality system is certified to ISO 13485, and the certificate is available on request. It is the quality-system evidence most registration files ask for first.
CE marking
CE marking is a manufacturer's declaration for the European Union, and whether a CE route applies depends on the product classification and the market you intend to sell in. We do not claim a CE mark unless it exists for the item concerned, and we will put our position in writing for your specific product and market. Where a CE route is in scope, we prepare the technical file and work with your notified body or consultant.
Other schemes
If your market asks for a free-sale certificate, a certificate of origin, batch certificates of analysis or a letter from the manufacturing site, we issue it with the shipment or on request.
Middle East and the GCC
The Gulf is not a single market. Saudi Arabia, the United Arab Emirates, Bahrain, Kuwait, Oman and Qatar each run their own registration and appoint their own authority, although the safety baseline is shared across the region.
Two things are the same everywhere: Arabic labelling is a legal requirement, and a locally established importer or authorised agent has to be the accountable party.
Saudi Arabia
The Saudi Food and Drug Authority is the regulator. Cosmetics are notified through its electronic system and cleared shipment by shipment, while medical devices are registered separately and one by one. Both routes need a Saudi legal entity to file for you.
United Arab Emirates
Cosmetics are registered emirate by emirate through the municipal product system, with a conformity certificate issued at federal level. Medical devices are registered with the Emirates Drug Establishment. A locally licensed importer is required.
Bahrain, Kuwait, Oman and Qatar
Each of these four states registers products nationally through its own health or standards authority. The safety and claims requirements are largely common, but the administrative route and the evidence each authority asks for are not.
What we supply for the region
- Arabic label artwork and bilingual ingredient lists prepared for the destination country.
- Product technical files and the free-sale and analysis documents your agent has to file.
- Information about our formulations that your market or your buyer asks for.
Three things we need from you
Destination country and product category
Device or cosmetic, and the classification you expect. The same product can sit on a different route in a different country.
Your appointed local agent
The importer, distributor or authorised representative who will file. In the EAEU and in the GCC this has to be a locally established entity, and we cannot appoint one for you.
The claims you intend to use
Registration is assessed against what the product says about itself. Tell us the wording you plan to put on the pack, and we will confirm what our documentation can support.
How a registration project runs
Send us the destination country, the product category and your agent's details. We confirm what we can supply, prepare the file, and stay in the loop while your agent files it. Timelines depend on the destination authority and on how complete the file is, so we set them per project instead of quoting a generic figure.
Where to go next
- Certifications — See the licences and registrations held by this site.
- Catalogue — See the registered items available to your market.
- Factory — See how and where the products are made.
- FAQ — Read the commercial questions buyers ask us most.
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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