Certificate of Free Sale (CFS) from Japan

What a CFS actually says

A Certificate of Free Sale states, in formal language, that a named product (or product family) of a named Japanese company is freely sold on the Japanese domestic market and that the Japanese authority is not aware of any restrictions on its sale in Japan. It does not certify safety, efficacy, or compliance with destination-market rules. Treating a CFS as a safety document is one of the most common buyer-side misunderstandings.

Who issues a CFS in Japan

Unlike many other jurisdictions, Japan does not have a single centralised issuer for CFS documents. Which body the destination market will accept varies, and overseas buyers should confirm acceptance with the destination authority before requesting a specific issuer.

• Ministry of Health, Labour and Welfare (MHLW). The most authoritative source for cosmetics, quasi-drugs, drugs, and medical devices. Application is typically routed through the prefectural pharmaceutical affairs division.
• Pharmaceuticals and Medical Devices Agency (PMDA).Supports MHLW on technical review for cosmetics, quasi-drugs, and drugs; does not normally issue CFS directly but is referenced by MHLW-issued certificates.
• Prefectural government. For food products, some prefectural governments will issue a CFS within their scope.
• Local Chamber of Commerce (JCCI member chambers).Commonly accepted for food and consumer goods. Faster than the MHLW route and routinely used for South-East Asia and Middle East destinations.

How overseas buyers obtain a CFS in practice

Overseas buyers do not apply for the CFS themselves. The Japanese manufacturer or its Japanese marketing-authorisation holder (MAH) applies, and the document is then forwarded to the buyer or directly to the destination authority. The practical sequence is usually:

1. The destination market authority publishes a list of accepted CFS formats and issuers. Check this first; an MHLW-issued certificate will not necessarily be accepted if the destination expects a Chamber of Commerce format, and vice versa.
2. The buyer requests a CFS from the Japanese OEM manufacturer, in writing, specifying the destination market and the issuer that authority will accept.
3. The Japanese MAH or manufacturer applies to the agreed issuing body. For MHLW-route certificates, the prefectural authority forwards the application; processing typically takes 2–6 weeks.
4. For destinations that require apostille (Hague Convention members) or consular legalisation (non-Hague members), the certificate is routed through Japanese Ministry of Foreign Affairs and the destination consulate after issuance. This adds another 2–4 weeks.
5. The legalised CFS is delivered to the buyer for submission with the destination import registration.

Common destination-market patterns

• South-East Asia (Vietnam, Indonesia, Philippines, Thailand). CFS is required for cosmetics and food registration. Chamber of Commerce format is commonly accepted; consular legalisation at the local Japanese consulate is usually required.
• Middle East (UAE, Saudi Arabia). CFS is required for cosmetics, food, and supplements. Apostille and consular legalisation are usually both required, even for Hague members.
• China. CFS-equivalent documentation requirements have changed several times. NIFDC (formerly SFDA) acceptance varies by product category; confirm current requirements with the destination importer before requesting issuance.
• European Union and United Kingdom. Cosmetics registration via CPNP (EU) or SCPN (UK) does not require a CFS as such, but a CFS may be requested for food and supplement notifications in some member states. Check destination-state rules.
• United States. A CFS is not part of the standard FDA registration pathway for cosmetics or food, but is sometimes requested by buyers for due-diligence purposes.

What can go wrong, and how to avoid it

• Wrong issuing body. The most common rejection reason. Always confirm with the destination authority — not just the local importer — which Japanese issuing body is acceptable.
• Product name mismatch. The CFS must name the product exactly as it will be registered with the destination authority. Any difference in product name, even punctuation, can trigger rejection.
• Expired certificate. Many destinations accept only a CFS issued within the last 6 or 12 months. Buyers stockpiling early CFS copies often end up needing to re-apply.
• Missing legalisation chain. An apostille is not the same as consular legalisation. Some destinations require both, some require one, some accept neither. Confirm the full chain before starting.