Many companies ask that they can sell their products throughout the EU with CE, but if they sell their products to many non-EU countries, they require us to provide a free sale certificate issued by the EU government. Why do you need this certificate? Where can I do that?

What is a Free Sale Certificate?

The EU Free Sale Certificate is also called the Export Sale Certificate, the English name is: Free Sales Certificate, Certificate of Free Sale or Certificate For Exportation of Medical Products, FSC or CFS for short.

The free sale certificate originated in Europe. In the beginning, individual member States of the European Economic Area Agreement (EEA) and civil associations within member States in order to promote their products to third countries outside the EEA, issued a free sale certificate for local manufacturers, which is to prove that the product meets the relevant national standards, meets the relevant directive requirements, and the product is safe and reliable, and the quality meets the relevant requirements. It can be sold freely within the country and allowed to export and so on.
The original free sales certificate was issued by the European civil association, the Chamber of Commerce and other institutions, and then it was perfected by some European countries to form a system suitable for their own countries. This free sales trade barrier from Europe has gradually been recognized by some countries in the world, and they will require the shipper of goods to provide the corresponding free sales certificate when importing products. The only institution authorized and qualified by the EU directive should be the Competent Authorities(CAs) of the EEA member States for medical devices, mostly official institutions (rather than free sales certificates for exports to Argentina), and should not be issued by private manufacturers' associations. 
With the CE mark and the EU registration required in the relevant directive, Chinese manufacturers do not need a free sales certificate to export to the EU.


Scope of application of free sale certificate

Some countries outside the member States of the European Union may, in principle, require a certificate of free sale in any destination country. At present, from our experience, the countries and regions with relatively concentrated requirements are South American countries, Middle East countries, Southeast Asian countries and so on. For example, Egypt, Uruguay, Venezuela, Saudi Arabia, Turkey, Brazil, Argentina, Kazakhstan, Thailand, India, Indonesia, etc.
At present, all FSCS in Europe are only awarded to companies located in their territory, which can be manufacturers, EU representatives, etc.


Classification of free sale certificates

According to the issued institutions are basically divided into three categories:
1、National and industry associations; No products of industry authorities

2、Competent national authorities, such as the Ministry of Health, the Drug Administration, the commodity Inspection Bureau, etc.;   Have the products of the industry authorities and meet the domestic industry regulations

3、Issued by a foreign competent authority, such as the United Kingdom or the European Union, the United States, etc
As can be seen from the table above, manufacturers or export traders should choose to apply for appropriate free sales certificates according to the categories and specific circumstances of the products they export.
If you produce medical device products, in the country has a product registration certificate and medical device production license, then you can apply to the State Food and Drug Administration to apply for the corresponding free sales certificate. Depending on the type of device, it may be issued by national, provincial or municipal offices. To be clear, this certificate is only issued to the manufacturer, and must be registered by the manufacturer and license.

What about trading or e-commerce companies who want to apply for a certificate? For the manufacturer to export the product, and the product has not yet obtained the registration certificate and license in the country, the customer needs free sales proof what to do? In this case, you can choose the third option above, a certificate of free sale issued by a competent authority abroad.

In addition to the free sales certificate issued by the competent authorities of the European Union, foreign buyers will also require domestic manufacturers to do consular certification or the Hague certification, Shanghai Xiangshan Testing Technology Co., Ltd. relying on industry resources, can provide enterprises with free sales certificates issued by the Spanish Ministry of Health, the Dutch Ministry of Health, the German Ministry of Health, the British Ministry of Health.

Because of the particularity of medical devices, many countries do not have a separate regulatory system, so they will refer to the registration certificate issued by other countries to manage the products imported into their own countries, so the free sale certificate appears.

EU - Free sales certificate FSC processing：

The FSC of the European Union is generally initiated by the manufacturer, and is handled by Odai. The condition for handling is that the product must obtain the CE certificate, and all the products can be written on a certificate, which is different from Odai. The fee is different. Unless otherwise specified, FSC will do the Hague certification. In this way, the certificate will be recognized in all Hague Convention countries.

Note: Generally, countries in the Americas and Oceania will choose the FSC issued by the European Union as the support for registration.