Regulatory

Registration, handled before anything ships.

Medical devices and cosmetics need market registration before they can be sold. We check each product against the rules of your market and handle the filings, representatives and labels.

How we report status

Clear status, per product group and market

Supplied
Registered and already shipping to this market.
In progress
Registration filed. We share the expected timeline in the quote.
Available on request
Not registered yet. We can register it for your order.
Not applicable
The product does not need registration in this market, or we do not supply it there.

Certificates are issued in the manufacturer’s name. We share copies with buyers on request, together with the registration number and the date we last checked it.

Market guides

What each market requires

A short overview of the main requirements. Rules change, so we confirm the current requirements for every order.

United States

Medical devices: FDA. Class I–III. Establishment registration and device listing; 510(k), De Novo or PMA depending on class. Foreign establishments need a US Agent.
Cosmetics: FDA under MoCRA: facility registration, product listing, safety substantiation, adverse event reporting. Sunscreens are OTC drugs.
What Meridiem handles: Registration and listing, US Agent, 510(k) preparation support, English labeling

Saudi Arabia

Medical devices: SFDA Medical Device Marketing Authorization (MDMA). A local authorized representative is required.
Cosmetics: SFDA cosmetic product registration, Arabic labeling.
What Meridiem handles: SFDA filings, authorized representative, Arabic labels

UAE & GCC

Medical devices: Registration with the UAE health authority; other GCC states register separately.
Cosmetics: Product registration per emirate or state. Halal certification is optional but valued.
What Meridiem handles: Registration filings, halal-certified options, re-export documents

Kazakhstan & Kyrgyzstan

Medical devices: EAEU unified registration or national registration. Russian-language documents and instructions.
Cosmetics: EAEU technical regulation TR CU 009/2011, declaration of conformity and EAC marking.
What Meridiem handles: EAEU and national filings, Russian labels and IFU

Uzbekistan

Medical devices: National state registration (not an EAEU member).
Cosmetics: Conformity certification and registration under national rules.
What Meridiem handles: National registration filings through local partners

Korea

Medical devices: MFDS. Class 1–4. Notification, certification or approval by class; importer licence and GMP.
Cosmetics: MFDS. Responsible-seller registration; functional cosmetics reviewed or reported.
What Meridiem handles: Import under Meridiem’s licences for domestic distribution

This page is a general overview, not legal advice. Requirements depend on the product and change over time.

Quality systems

What we ask of manufacturers

ISO 13485

Quality management system for medical device manufacturers.

ISO 22716

Good manufacturing practice for cosmetics.

MFDS GMP

Korean GMP for medical devices.

Test reports

Electrical safety, biocompatibility, stability and other reports as each market requires.

Check a product for your market.

Send the product and the country. We will tell you what registration it needs and how long it takes.

Ask our regulatory team