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Document Certification

Introduction

For the importation of medical products and apparatus into Thailand, the Thai Food & Drug Administration requires that each U.S. vendor present a *CERTIFICATE ...* to their Thai importer or distributor for use in obtaining clearance of incoming goods through the Thai Customs Department.

For ANY & ALL OTHER types of certificates or legal documents, please see the Thai Embassy website for more information.

*CERTIFICATE ...* The type of Certificate required varies depending on the following:

I) If the product is regulated in the U.S. market by the U.S. FDA, then a Certificate to Foreign Governments (or equivalent), issued by the U.S. Food & Drug Administration may be used.

II) If the product is NOT regulated in the U.S. market by the U.S. FDA, then an original (AND NOT A CERTIFIED COPY) Certificate to Foreign Governments, issued by the Secretary of State or State Chamber of Commerce or Department of Health (located in the same state as the product's manufacturer) may be used. This document must be on their official agency letterhead.

**NO self-issued documents (i.e. on a company's own letterhead) can be accepted**

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Please Note:

Certificate of Free-Sale is also known as (depending upon usage): Certificate to Foreign Governments or Certificate of Products for Export or Certificate of Exportability. They are, for certification purposes, interchangeable.

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Procedures

Some of the below steps are prerequisites required by the Royal Thai Government (noted by T), while others are requirements of the US Government (noted by US). For more information on the US procedural requirements, please contact the US Department of State (see below contact list).

1. The Original Document

■ If your document is an original *Certificate ... * from the U.S. FDA (or equivalent Federal-level US Government Agency, i.e. USDA, etc.) - Go to step #4.

■ If it IS NOT from the U.S. FDA or other Federal-level US Government Agency (i.e. it is a State-level document such as a manufacturer's State Chamber of Commerce or Secretary of State or other State-level government Agency) - Go to step #2.

2. The document must be signed and notarized (US).

3. The document must then be sent to the Secretary of State (of the state in which the document was issued), so that the Notary's standing / document's authenticity may be verified (i.e. Florida issued documents must go to Florida Secretary of State. The Office of the Secretary of State for each state is usually located in your state's capital city.) (US). For a listing of all U.S. Secretaries of State, click here.

4. The document must then be forwarded to the the Office of Authentication, US Department of State (For full contact information, see below) (T).

NOTE: Please contact their office for the most up to date information on fees and procedures before sending any documentation to them.

5. The document must then be forwarded to us. After Step #4 You may a) either have the document returned to you first, after which you can then forward it to us OR b) alternatively, you may enclose a cover letter instructing the Office of Authentication to forward the documents directly to our office.

6. Before sending the document to our office (or having it forwarded to us from the Office of Authentication), please verify that you have enclosed the following:

• Our certification fee of US$ 15.00 per set of documents (Certified or company checks or money orders only. No personal checks, please. Made payable to: Office of Commercial Affairs, Royal Thai Embassy).

• Appropriate return postage (or Fedex account # or UPS envelope). Please use a traceable mail carrier. We cannot bear responsibility for any in-transit losses that may occur nor from any losses caused by the delivery services themselves.

If you have any questions, please contact us before sending any documents.

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Contact Information

• Office of Commercial Affairs, Royal Thai Embassy

■ 1024 Wisconsin Avenue, NW, Suite #202, Washington, DC 20007

■ Phone: 202-467-6790 x11,

■ Fax: 202-429-2949

■ Email: inquiries@commercethaiusa.org

• Office of Authentication, U.S. Department of State

■ 518 23rd Street, NW, State Annex #1 , Washington, DC 20520

■ Phone: 202-647-5002

■ Fax: 202-663-3636

■ Email: AOPRGSMAUTH@STATE.GOV

■ For more information, see: http://www.state.gov/m/a/auth/

• U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition

■ 5100 Paint Branch Parkway, College Park, MD 20740-3835

■ Toll-Free Information Line: 1-888-SAFEFOOD or (1-888-723-3366)

■ Email: Industry: industry@fda.gov or Consumers: consumer@fda.gov

■ Also useful is the: US FDA Compliance Policy Guide