Certificate of Free Sale (CFS) is a vital certification for the manufacturers of medical devices to do business in open market. When exporting a medical device, CFS is an additional requirement needed by manufacturers to ensure that they the device is already available in the market of exporting country (where the manufacturer is based).
A CFS is a verification that the device is safe to use in the country where it is being exported. For medical devices manufactured in the European Union, it is essential for manufactures to make sure that the CFS must endorse that the exporting medical device contains CE marking.
On behalf of the manufacturer, an EC Rep (the EU Authorised Representative for medical devices) submits an application to a European Competent Authority to issue CFS.
Purpose of Certificate of Free Sale
Acquiring CFS is a fundamental task for manufacturers of medical instruments that want to foray into the markets other than their country of origin. For EU-based manufacturers of medical products, CFS is proved to be very vital to capitalize on the Middle Eastern healthcare sector which remains in great demand of medical instruments that are already in use in the territory of European Union.
Securing CFS is crucial for multiple reasons for manufacturers going international with their medical products.
Verification of the Manufacturer
Even though the verification that the manufacturer is an authorized business entity can be performed through several ways, but CFS is a definitive proof that the manufacturer contains a valid license. An authentication of manufacturer’s license then automatically validates that the business is complying with the guideline needed for CE marking.
Verification of the Product
Importing countries want to maintain a strict level of safety and health in their healthcare sector. Therefore, they won’t allow the use of medical device, pharmaceutical products and other critical products from a manufacturer that can’t furnish a proof that a certain exporting medical product is authorized to be used in the country where its operations are based.
For that purpose, CFS is an important piece of information where the associated regulatory body vouches for the importing manufacture that a specific certified medical device is an authorized healthcare product in the county where it is manufactured.
Verification of GMP Compliance
CFS is also an authentication of the fact that the device in question complies Good Manufacturing Practice (GMP) guidelines of International Society for Pharmaceutical Engineering. Aside from CE marking, it is another important certification which further endorses the veracity of any medical product.
As you can see how much crucial information a CFS for a medical device can entail. The fact that makes CFS more important is that it is, in essence, a guarantee issued by the importing country to the exporting country about the authenticity of the manufacturer and its product.
For manufacturers interested in going global with their medical devices, we can provide them with the services to apply and secure CFS from the ministry of export. We also provide the necessary testing required for CE marking and other pertinent certifications.
Find More Insights
Construction Products Regulation 2013
The lifts and safety components of lifts Directive 2014/33/EU
CETA, Trade agreement between the EU and Canada
Personal Protective Equipment (PPE) Regulation EU 2016/425
Full-service product compliance
Leave it to us.