Free Sale certificate/Certificate for free sale/ Free trade certificate

Free Sale certificate is a certificate required in certain countries for certain commodities, medical devices, or other products or goods that are imported, freely moved, and sold in the importing country.

The Free Sale Certificate/Certificate for Free Sale is proof that the devices, products could be legally sold without any restrictions with the approval of the representative authority in the exporting country. It is a product certificate that verifies that the product that the consumer is buying is a genuine product. For example, If the manufacturer wants to cater to the market of the EU then he needs to fulfil the EU directives by embellishing CE marking to the products. Likewise, if the manufacturer wants to market its product to other countries than the EU, the customers can ask for the Certificate for Free Sale from the manufacturer to provide authenticity of the product. The manufacturer will get this Certificate of Free Sale (CFS) from the representative authority based in the second country or the exporting country by providing the documents to their national Regulatory Authority to sell the product freely in the exporting country.

For such attestation from the relevant authorities, there is a requirement of identifying and hiring an Authorised Representative to be based in any EU country.

Many ministries of health and other foreign manufacturer require CFS certificates are approved to freely sold in the exporting countries. It gives assurance from the foreign authority that the product is evaluated for safety and efficacy and is registered under foreign authority for use in the country.

Free Sale Certificate for Medical Devices

CFS certificate is an important certification for the manufacturer that the device or product can be sold freely in some specific country. When exporting a Medical Device, IVD Active Medical Device, CFS is an additional requirement for certain countries or maybe in the open market. A CFS certificate is issued by an authorized representative based on the European Union on behalf of the medical device manufactured in a particular country, exported to a third country.

To get a CFS certificate for medical devices or Class IVD devices then:

• The Product should have been tested against EU Directives and relevant Harmonised Standards;
• Devices must already have CE marking
• Manufacturers must have authorized representatives for that device to be sold freely in other countries.

Medical devices considering CE marking, but do not comply or registered under European Authorised Representative is not applicable for CFS certificate and CE marking is no longer valid.

To achieve CFS certification manufacturer need to provide these documents to the authorized representative.

• Information and details about the device
• Classification of class(according to EU regulation)
• Composition and description of the product
• CE Marking Certificate
• Information about the manufacturer (Name, Company address and contact details)
• Technical file about the product
• Manufacturing License
• Letter of authority demanding certificate
• Copy of power of attorney

A CFS certificate is issued by the relevant Regulatory Authority (generally Ministry of Health or Ministry of Industries from any EU country) on behalf of an EU representative.

 The Representative is the legal person located in the EU nation to fully responsible for the legal authorities and the safety of the product ensuring compliance with the regulation and rules of the nation.

According to the EU regulation, each product should pass the EU regulation before placing them in the market. The Representative person also ensures that the product comes under Good Manufacturing Practices GMP ISO 9001 and ISO 13485. All information and detail related to the product the material used, process, design, and method should be readily available for the Regulatory Authority present in the EU nation. The Representative person will be responsible for any drawbacks or any fault in the product.

The Certificate For Free Sale is issued in the county where the Representative Person(RP) is located irrespective of the manufacturer’s location.

Which products come under the CFS certificate?

CFS Certificate may be applicable on products which contain the CE marking certificate and manufacturer want to sell outside EU nations. Ex. If the manufacturer wants to sell a face mask in china then the receiving country can ask the manufacturer to provide them with a CFS certificate.

The requirements of free Sale Certification are

• Application in the form of a Descriptive covering letter.
• Copy of the valid manufacturing licenses
• List of products for which a Free Sale Certificate is required
• Copies of the product permission letters of the requested products for the issue of the Free Sale Certificate
• Relevant Application Fee for Free Sale Certificate containing products in one certificate Representation Fees.
• Letter of the concerned authority-demanding certificate
• Copy of the power of attorney/authorization letter

The above documents are just indicative. The list of documents is subject to change depending upon the regulatory authority from time to time.

Ascent WORLD helps you with gaining the Authorised Representative (EU Representative) for CFS certification and even MHRA certification and attestation for the product. Hence, in respect of this,

• We can request for CFS certificate from the authorized authority in any EU nation easily.
• We have gained the European market since 2007.
• We have EU Representative in the EU nation proving CFS certification.
• Our EU Representative contacts the Regulatory Authority for the competence of the CFS Certificate.

Contact the Ascent WORLD for an easy and quick process of Free Sale Certification/ Certificate of Free Sale and help you in conquering the global market.