Free Sale Certificate (FSC)
No matter which product you use, no matter which country you are aiming for market recognition. STATELABCERT will get you to your destination quickly and safely.
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Selection of notified body
Compile a list of required documents
What is a Free Sale Certificate?
Free Sales Certificates, also known as export sales certificates, English name is Free Sales Certificates, referred to as FSC. The content of the free sale certificate is usually to prove that the medical product can be freely sold in the country where the certificate is issued.
What are the main institutions that can currently issue CFS?
At present, the main medical device authorities in the United Kingdom, the Netherlands, Germany and other countries.
What are the official languages of the Free Sale Certificate?
The German Free Sale Certificate is in the form of a bilingual divider, with the first column in German and the second in English.
Which countries require a certificate of free sale of imported medical products?
In principle, any destination country may require a certificate of free sale. 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, Argentina, Australia, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, India, Iraq, Israel, Japan, Jordan, Lebanon, Mexico, Oman, Peru, Qatar, Russia, Saudi Arabia, South Korea, Sri Lanka, Syria, Thailand, the United Arab Emirates and other countries require exporting countries to issue medical products for their exports A valid certificate of free sale is required before the product is approved for sale in the importing country.
Does the certificate need to be authenticated by the Hague or the embassy?
Varies with customer needs. Some countries require the certificate to be authenticated by the Hague or the embassy before it can be used locally, which is to ensure the authenticity of the document. The premise of Hague certification is that the destination country and the issuing country are members of the Hague Convention. If the destination country is not a Hague Convention country, embassy accreditation is required. Embassy certification is done by the embassy of the destination country in the issuing country.
How long does it take to issue a free sale certificate?
Usually, if the registration is completed, the application period is less than 8-10 weeks; If the certificate needs to be authenticated by the Hague or the embassy, it usually takes an additional 1-2 weeks. However, if you happen to hit the peak vacation or sick leave in Germany, you may exceed the normal waiting time.
Can one certificate of Freedom of Sale be issued to multiple countries? What is the charge in this case?
A free sales certificate can only be for one country, if you need to target multiple countries, you need to issue multiple free sales certificates, and the certificate fees are calculated separately for each country.
How do I charge for multiple FSC certificates that are identical?
There are no copies of the FSC Free Sale Certificate, and if multiple copies of the same original certificate are required, the fee will still be charged at a multiple of the corresponding single copy fee. For example, if two identical FSC certificates for Thailand are required, the fee will be twice that of one FSC certificate.
Is there a price difference between issuing a certificate of free sale for some products and issuing a certificate of free sale for all products?
We issue free sales certificate according to the quantity of products charge, the specific price please refer to the quotation, customers can according to the need, flexible choice of product quantity, not necessarily issued all products.
After selecting the German EU representative, what else do I need to do to get the free sale certificate?
First through Odai in accordance with EU regulations to do the product in the EU record (registration), registration is successful in order to apply for free sales certificate, all work is completed by Odai.
What information should be included in the application for a Certificate of Free Sale?
There is no official application form for the issuance of a certificate of free sale, only a written application can be submitted. The written application must include the following:
Importing country information.
If you need to apply for notarization or Hague certification at the same time, please indicate.
List of products.
Documents certifying the distribution of the product in the market.
For details, please download our FSC application form
The documents that need to be prepared by the enterprise are:
① CE certificate and ISO13485 certificate
② Product conformity declaration
③ Product English label and instruction manual
④ Product photos
⑤ Technical documents