Certificate of Free Sale (CFS)
Dietary supplements, medical foods and foods for special dietary use.
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FDA Embassy Legalization for Malaysia
FDA Embassy Legalization for Malaysia
Malaysia is not a party to the Hague Apostille Convention, so U.S. FDA certificates for Malaysian files need embassy legalization. We take your certificate through U.S. Department of State authentication and legalization by the Embassy of Malaysia in Washington, then FedEx it to you or your Malaysian authorized representative in about 14 business days.
- Not in Hagueembassy legalization needed
- Two-step legalizationdocument route
- Malay (English widely used in business)official language
- 14 daysstandard processing
Get Your FDA Certificate Ready for Malaysia
Simply upload your FDA digital file, and you will receive your legalized document via FedEx.
Processing time 14 business days
- We accept credit card payments.
- Track your order history and expenses online.
- U.S. Department of State and embassy fees are already included.
- Submit the files you received from the FDA electronically.
- We use the State Department minimum processing time.
- You may update your own FedEx air waybill or purchase a new one.
- U.S. Department of State Form DS-4194 is not required; we handle it.
Exp. Service fee$120 / Doc.
US Dept. of State fee$20 / Doc.
Embassy of Malaysia fee$5 / Doc.
Total:$145 / Doc.
FedEx return shipping is available for completed documents after processing.
See expedited options →Why Malaysia Asks for a Legalized FDA Certificate
Malaysia splits health-product oversight between specialist agencies under the Ministry of Health. The National Pharmaceutical Regulatory Agency (NPRA) registers medicines, health supplements and traditional products and receives cosmetic notifications. The Medical Device Authority (MDA) registers devices under the Medical Device Act 2012 (Act 737), in force since 1 July 2013. Food is overseen by the Ministry's Food Safety and Quality Division. Registrations and notifications must be held by a company incorporated in Malaysia.
U.S. approvals open a faster door for devices. MDA's verification pathway is an expedited route for Class B, C and D devices already approved by a recognized reference authority, and the U.S. FDA is on that list. It relies on the existing approval, so the conformity assessment body's review is narrower, and MDA's own review is set at 60 working days. A legalized FDA certificate helps your representative show that approval clearly.
Which FDA Certificate Does Your Malaysian Importer Need?
Match your product to the Malaysian authority that reviews it and the FDA certificate that authority normally expects.
| Product type | Malaysian authority | FDA certificate |
|---|---|---|
| Medicines & health supplements | National Pharmaceutical Regulatory Agency (NPRA) | Certificate of a Pharmaceutical Product (CPP), Certificate of Exportability |
| Medical devices | Medical Device Authority (MDA), Act 737 | Certificate to a Foreign Government (CFG), Certificate of Exportability |
| Food & ingredients | Ministry of Health, Food Safety and Quality Division | Certificate to a Foreign Government (CFG), Health Certificate |
| Health supplements | NPRA, product registration | Certificate of Free Sale (CFS) |
| Cosmetics | NPRA, ASEAN cosmetic notification | Certificate for Cosmetics |
NPRA handles medicines, supplements and cosmetics, MDA handles devices, and the Food Safety and Quality Division handles food. Your Malaysian authorized representative or license holder will confirm which FDA certificate each file needs.
How FDA Embassy Legalization for Malaysia Works
Malaysia is not a party to the Hague Apostille Convention, so it does not accept apostilles. Your FDA certificate is first authenticated by the U.S. Department of State and then legalized by the Embassy of Malaysia.
Upload your FDA certificate
Send the digital certificate exactly as the FDA issued it and choose Malaysia as the destination.
State Department authentication
We submit it to the Office of Authentications, which issues the federal authentication certificate in about 9 business days.
Embassy legalization
We take the authenticated certificate to the Embassy of Malaysia for legalization, which takes about 5 business days.
FedEx delivery
The legalized certificate ships to you, your importer or your agent in Kuala Lumpur or anywhere else.
Exporting to Malaysia: What to Prepare
The verification pathway
Devices already cleared by the U.S. FDA can use MDA's verification pathway, with a narrower conformity assessment and a 60-working-day MDA review. Simple Class A or B devices can be on the market in about four months.
A local authorized representative
Foreign manufacturers without a Malaysian entity must appoint a Malaysian-incorporated authorized representative, who holds the device registration. NPRA product registrations and cosmetic notifications must also be held by a local company.
Five-year device certificates
MDA registration certificates are valid for five years, and re-registration must be filed at least a year before expiry. Cosmetic notifications with NPRA run for two years, so plan regular renewals.
Halal and food imports
Ordinary processed food is not pre-registered, but imports are notified electronically and inspected on arrival. Halal certification is voluntary for most products but required for meat and animal products and for anything marketed as halal.
FDA Embassy Legalization Cost for Malaysia
| Item | Amount | Notes |
|---|---|---|
| Our service fee | $120 / doc. | Review, submission, tracking and FedEx dispatch |
| U.S. Department of State fee | $20 / doc. | State Department authentication, about 9 business days |
| Embassy of Malaysia fee | $5 / doc. | Embassy legalization, about 5 business days. Paid by us on your behalf |
| Total | $145/ doc. | Standard processing: 14 business days. Expedited options available. |
FDA Embassy Legalization for Malaysia: FAQs
Does Malaysia accept apostilles?
No. Malaysia is not a party to the Hague Apostille Convention, so FDA certificates need U.S. Department of State authentication followed by legalization at the Embassy of Malaysia.
How long does FDA embassy legalization for Malaysia take?
About 14 business days: roughly 9 at the State Department and 5 at the Embassy of Malaysia, then FedEx delivery.
How much does it cost?
$145per document: our $120 service fee, the $20 State Department fee and the $5 Embassy of Malaysia fee.
Does Malaysia rely on U.S. FDA approvals for devices?
Yes. The Medical Device Authority's verification pathway accepts devices already approved by recognized reference authorities, including the U.S. FDA, with a narrower review.
Do I need a local company in Malaysia?
Yes. Device registrations are held by a Malaysian authorized representative, and NPRA registrations and cosmetic notifications must be held by a company incorporated in Malaysia.
Which FDA certificate does Malaysia need?
Malaysian files usually rely on a CPP for medicines, a CFG for devices and foods, a Certificate of Free Sale for supplements and a Certificate for Cosmetics for cosmetic products. Products not sold in the U.S. need a Certificate of Exportability.
FDA Certificates We Legalize for Malaysia
Certificate to a Foreign Government (CFG)
Medical devices, conventional foods, food additives and infant formula sold in the U.S.
Certificate of a Pharmaceutical Product (CPP)
The WHO-format certificate used to register human drugs.
Certificate of Exportability
Products made in the U.S. for export only.
Health Certificate
Collagen and gelatin exports (EU health certificate or SRM certificate).
Certificate for Cosmetics
Skincare, makeup, haircare and fragrance products.
Nearby destinations
Get Your FDA Certificate Legalized for Malaysia
Upload your FDA certificate today and receive it legalized by FedEx in 14 business days, for $145per document with State Department and embassy fees included.
Start Your Order Ask a Question
Simply upload your FDA digital file, and you will receive your apostilled document via FedEx.
Processing time
14 business days
- We accept credit card payments.
- Track your order history and expenses online.
- The U.S. Department of State fee is already included.
- Submit the files you received from the FDA electronically.
- We use the State Department minimum processing time.
- You may update your own FedEx air waybill or purchase a new one.
- U.S. Department of State Form DS-4194 is not required; we handle it.
Exp. Service fee
US Dept. of State fee
Embassy of Malaysia fee
Total:
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