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Certificate of Free Sale for Export

 

When exporting to 3rd (1st Country- where the manufacturer is located; 2nd Country- A Country in the European Union, where there is an appointed Authorised Representative and of which, the Ministry of Health certifies) countries, organizations and companies are often required to maintain a Certificate of Free Sale (CFS) as part of their export documents.

A CFS is basically an attestation made by the EU Responsible (designated through EU License statement and listed) Person (Authorised) that the product(s) technically and safety-wise complies with the various (one or more than one) EU Directives and Regulations and may be freely sold across the EU.

A CFS is likewise considered and called a ‘Certificate of Manufacture’ or a ‘Health’ or ‘Safety Certificate’ by certain non-EU countries.

Certificate of Free Sale (CFS) is an important certification of assurance for the manufacturers of 

  • Cosmetic Products
  • Medical Devices
  • IVD
  • Active Medical Implants

Benefits of Certificate of Free Sales include, though not limited to:

  • Manufacturer’s Assurance of meeting to all Regulatory requirements of the EU.
  • Manufacturer’s Assurance of meeting to all Regulatory requirements of the Country of Import and from where it is sending / Exporting.
  • A fool-proof understanding amongst all relevant stakeholders about the product/item/batch formula, ingredients and ratios, methods of manufacture, and the various safety assessments are done.
  • A Basic understanding that the Manufacturer is following all relevant EU Directives and Regulations.
  • A Certificate of Free Sales is issued from a European Competent Regulatory Authority after a written and valid request from the localized and Authorized Representative (based inside the EU)e on behalf of a Medical Device / IVD or relevant product manufacturer. The Certificate endorses and conforms and certifies that the product may be legally marketed in the European Union. 
  • Demonstration by way of approved and regulated Conformity Assessment Methods that their product/device/item/batch meets the 100% requirements established by the respective EU Directives / Regulations, including mandatory regulatory requirements- Technical Device file, Registration documents, Testing reports, COAs, etc.
  • Many times it is a requirement from the Importing Customer who wants added assurance about the performance of the product, in terms of safety and quality and an endorsement from the relevant authority. This depends on the Customer’s choice, requirements, and criticality of the product.
  • Prohibits the manufacture and import of non-conforming products.
  • Health and Safety of End-users / Consumers and patients (where relevant) are not compromised beyond a limit.
  • The Products meet requirements of Safety and Quality and Performance and don’t exceed the tolerable limits.

Who can issue a CFS?

A CFS is issued on behalf of the EU Responsible Person.

The Responsible Person (RP) is an authorized (EU listed and licensed) legal or natural person/organization located in the EU (any of the EU Countries) responsible and accountable for ensuring that its products are safe and in full compliance with the Regulation. The RP as to be easily identifiable as its address is labeled on the pack, and is listed on all Government databases as such.

According to the EU Regulations and Directives, each item/product must be assessed for safety by a duly qualified safety assessor (example CE Marking or an EU Declaration of Conformity) before it is made available to the public. The Responsible Person is also responsible to ensure that the product has been manufactured under specific CFR or WHO relevant Good Manufacturing Practices (GMP) or following ISO 9001 and/or ISO 13485- these are some pre-requisites. This requirement applies even if the product has been manufactured by another entity (outsourced) such as contract manufacturing. Information relating to each item/product, including its formula, its method of manufacture, and its safety assessment, must be ready and as required and whenever required be made available to the Competent and Regulatory Authorities of the EU Country where the RP is located.

A CFS is basically issued in the country of the Responsible Person, regardless of the production/manufacturing location (1st party), is therefore the accepted practice.

A CFS is requested directly by the manufacturer (that is generally what happens) or it can be on behalf of the Responsible Person, if the manufacturer authorizes the RP,  by its sub-contractors or consultant like Ascent WORLD Group.

 

Which organization in the EU can deliver a CFS?

A CFS, issued by the EU Ministry, under the relevant of the RP, might act as a valid and legal document accepted by several countries, including the EU countries. However, some EU and other authorities require the CFS to be issued and attested through the National Competent Authority (Ministry Level) or a relevant organization, which could be the Ministry of Health (however called) or if relevant, and if accepted by the country of Import by- Trade Association or a Chamber of Commerce for that country.

In some countries, the CFS is normally issued by the Department for International Trade (DIT) on behalf of the Responsible Person. The DIT CFS should confirm that the items/products listed meet the EU’s Europa Directives, and Legislations, and harmonized and other additional including safety and quality standards as they are being sold in the EU single market.

 

Scope of Ascent WORLD:

  • ISO 9001:2015 / ISO 13485:2016 / GMP Documentation, Training/Awareness, Audits and Certification.
  • CE Marking as is required.
  • Drawing up and helping the company/organization to develop all the relevant documentation needed to be submitted for CFS.
  • Appointing the most qualified Authorised Representative / Responsible Person (RP).
  • Selection of the Competent Authority- national Competent Authority (Ministry Level) or a relevant organization, which could be the Ministry of Health (however called) or a trade association like Department for International Trade and/or Chamber of Commerce for that country.
  • Submission of all Documents.
  • Following up with all relevant additional authorities.
  • Drawing up contracts of Company / Organization with Authorised Representative / Responsible Person (RP) and with Competent Authority- national Competent Authority (Ministry Level) or a relevant organization, which could be the Ministry of Health (however called) or a trade association like Department for International Trade (DIT or a Chamber of Commerce for that country.
  • Getting the CFS document.

 

Purpose of Certificate of Free Sale 

Acquiring CFS is many times a structural task for manufacturers / producing companies of various specified Items/devices/products that want to venture into the EU or other relevant markets (where relevant and asked upon) other than the actual country/location (if outside or even if it is inside the EU) of manufacture or origin. For EU-based manufacturers of products, CFS has actually demonstrated to be very crucial to basically capitalize on the various regions’ healthcare sector which remains in great demand for such items/products that are already in use in the territory of the European Union. Securing CFS is crucial for multiple reasons for manufacturers going international with their items/ products. 

 

Verification of the Manufacturer

Even though the compliance and subsequent verification that the manufacturer company is the authorized business entity- this is a mandatory requirement and that this can be performed through various substantiations and ways, but CFS will always remain a definitive proof that the manufacturer contains this valid license from a regulatory authority from the EU country. Authentication of the manufacturer’s license then automatically validates that the business and the products being manufactured, and being listed through the CFS is actually conforming with the quality and safety requirements and guidelines as needed for CE marking.

 

Verification of the Product

Importing (3rd party) countries want to maintain a strict level of quality assurance and safety and health in their healthcare and cosmetics sectors. Therefore, these countries (which might be as well outside of the EU) might not allow the import and usage of such organizations’ medical devices, medicinal/pharmaceutical / IVD products, and other specific (listed) critical products from this manufacturer (which might be as well outside of the EU) that can’t furnish proof that a certain exporting medical product is authorized to be used in the country where its operations are based. The importing country (which might be as well outside of the EU) also needs to understand the assurance of the quality and safety performance of such products.

Hence, CFS is essential to document evidence for information where the associated competent EU member/country regulatory body guarantees for the importing products’ manufacture that a specific certified medical / IVD device is an authorized healthcare product/item (batch or the entirety) in the county where it is manufactured.

 

Verification of ISO 9001, ISO 13485 and/or GMP Compliance and/or CE Marking requirements / Certification

CFS is also authentication of the fact that the item/product/device being manufactured and being exported to, complies with ISO 9001:2015, ISO 13485:2016 standards and Good Manufacturing Practice (GMP) guidelines; as well as CE Marking requirements (where the case might be).

So, additional to these, it is another crucial, and valuable certification (offered worldwide from Ascent WORLD Group) which further endorses the veracity of any medical product. So this is crucial information a CFS for an item/product/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 the performance of the product.

For manufacturers interested in going global with their medical devices / IVD devices/Cosmetic products, Ascent WORLD can provide them with the services to apply and secure CFS from the ministry of export. We at Ascent WORLD also provide the necessary testing and other required for CE marking and other pertinent certifications.

 

Certificates of Free Sale for Export Made easier from Ascent WORLD

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