Free Sale Certificate


 

Definition of Free Sale Certificate


The Free Sale Certificate (FSC) is also known as Export Sale Certificate. The Free Sale Certificate is usually used to prove that the corresponding product is a legally produced and/or sold product that meets the requirements of local laws and regulations in the issuing country. The regulatory agency of the destination country accepts the validity of the certificate of the issuing country and depends on it to determine that the product also meets the regulatory requirements of the destination country, or uses the certificate as one of the evidence.



Scope of Free Sale Certificate


Scope of products: in principle, the Free Sale Certificate can be applied for any product, but the issuing authorities of the certificate are different for different types of products.


Scope of destination countries: in principle, any destination country may require the Free Sale Certificate. At present, from our experience, the countries and regions with more intensive requirements are South American countries, Middle East countries, and Southeast Asian countries. For example, Egypt, Uruguay, Venezuela, Saudi Arabia, Turkey, Brazil, Argentina, Kazakhstan, Thailand, India, and Indonesia.



Classification and characteristics of the certificates


Depending on the issuing agencies, there are basically three classes:

SN

Issuing agency

Targeted product

   1

National and industrial associations;

Products without industrial competent authorities

   2

National competent authorities, such as the Ministry of Health, Food and Drug Administration, and Commodity Inspection and Testing Bureau;

Products with industrial competent authorities and meeting the domestic industrial regulations

   3

Foreign competent authorities, such as the Food and Drug Administrations of the UK, EU, US and other countries;

Products with industrial competent authorities but only meeting the export regulations



Questions and answers on certificate issuance overseas


1.   What are the main agencies that can issue the Free Sale Certificate of medical device products?

At present, they are the Food and Drug Administrations of the UK, the Netherlands, and Germany.


2.   What are the requirements for applying for the certificate from a foreign competent authority?

In principle, it shall be ensured that the product meets the regulatory requirements of the issuing country/region. For example, in the EU, a CE certificate is required for the high-risk product, and the low-risk product must be registered first.


3.   What is the validity period and application success rate of the certificates in these countries?


SN

Country

Validity period

Application success rate

1

UK

Indefinite

As long as the low-risk product can be queried in the global medical device database and the high-risk product has the CE certificate, you can get a CFS in principle.

2

Netherlands

Five years

As long as the low-risk product can be queried in the global medical device database and the high-risk product has the CE certificate, you can get a CFS in principle.

3

Germany

Two years

The judgment will be based on the instructions for use and the intended use, and there is a certain proportion of cases where the certificate cannot be obtained.



4.   Do these countries have any requirements for the destination countries when they issue the certificates?

At present, the destination countries of these certificates can be all countries in the world except the EU member states. Because the EU member states have the same regulatory requirements as the issuing countries, they are not in the scope of certification. In other words, if you meet the conditions for applying for the Free Sale Certificate, you have already met the conditions for the free sale in the EU.


5.   Will the Free Sale Certificate issued by the Medicines and Healthcare Products Regulatory Agency still be useful after the Brexit?

To answer this question, we need to understand the purpose of this Free Sale Certificate. The Free Sale Certificate is to prove to a third country that the product it intends to purchase has obtained the qualification for sales in the issuing country and meets all its regulatory requirements. In this sense, the more authoritative and prestigious the issuing country’s competent authority is in the world, the higher the validity of its certificate will be. The Medicines and Healthcare Products Regulatory Agency is currently a national competent authority that is internationally comparable with the U.S. FDA. Especially with its language advantage and legal integrity, the validity and influence of the Medicines and Healthcare Products Regulatory Agency’s certificate will not be affected by the Brexit.


6.   Why does the certificate need apostille or embassy legalization?

Some countries require the certificate to undergo apostille or embassy legalization before it can be used locally. This is an action to ensure the authenticity of the document. The prerequisite for apostille is that both the destination country and the issuing country are members of the Hague Apostille Convention, and it must be completed by the relevant British authorities. Taking the certificate issued by the UK as an example, since the UK is a member of the Hague Apostille Convention, as long as the destination country is a member of the Hague Apostille Convention, such as Argentina, apostille can be carried out. If the destination country is not a member of the Hague Apostille Convention, such as Saudi Arabia or Egypt, the embassy legalization is required. The embassy legalization is completed by the embassy of the destination country in the issuing country.


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