FDA Export Certificates

by Nikita Angane | Nov 13, 2020 | Certificates, Exports, FDA, Medical Devices, Pharma, Pharmaceuticals, Quality, Regulatory

Manufacturers that export FDA-regulated products such as drugs and medical devices from the US are oftentimes required to provide a certificate prepared by the FDA which confirms the product’s regulatory and marketing status.¹

In most cases, the foreign regulatory body requires an official assurance that the products being imported into their country from the United States have received the appropriate marketing authorization and follow GMP regulations of its country of origin.¹

Upon the company’s request, FDA will issue such certificates for human drugs and biologics, animal drugs, and devices that either may be legally marketed in the United States or may be legally exported, although they may not be legally marketed in the United States. FDA is not required to issue such certificates for food, animal feeds, dietary supplements, or cosmetics. However, whenever a foreign regulatory authority may require such certificates, the FDA will issue them as resources permit.¹

FDA bases its attestation of compliance on the firm’s most recent inspection by the FDA, its compliance history with the FDA, and other such information. FDA will not issue a certificate when:¹

FDA has initiated an injunction or a seizure for that product
The manufacturer does not operate within cGMP regulations
The facility is not registered and the product is not listed with the FDA
When the product is not going to be exported from the US

The following are the types of certificates offered by the FDA for medical devices:¹

Non-clinical Research Use Only Certificate: For export of a product for non-clinical research purposes only
Certificate to Foreign Government: For the export of medical devices that can be legally marketed in the US
Certificate of Exportability: For the export of devices that cannot be legally marketed in the United States but may be legally exported.

FDA may charge a fee of up to $175 if the FDA issues a certificate within 20 government working days, but will not exceed $175.¹

Are you looking to export your medical device and need help? Call us today at +1 248-987-4497 or email us at info@emmainternational.com to know more.

¹FDA (July 2004) FDA Export Certificates retrieved on 11/11/2020 from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certificates

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.