CERTIFICATE OF FREE SALES IN DUBAI, RAS AL-KHAIMAH, AJMAN, ABU DHABI, AL AIN, FUJAIRAH- UAE
A document that is required in specific countries or for specific items (such for pharmaceuticals) medical devices, general that are implantable, active or in-vitro certification. It states that the imported products are sold normally and readily within the exporting country’s open markets and have been accepted for export.
A lot of Ministries of Health and other regulatory bodies around the world require foreign companies to submit an official Certificate of Free Sale (CFS) which proves that their products have been approved to sell in Europe. When you are selling in these areas, your CFS has to be provided at the time of the registration process via EUDAMED. EUDAMED database. Ascent EMIRATES has acquired CFS documents for numerous clients who want to register medical devices, Vitro Diagnostic Devices in the European Union, and can obtain the CFS on behalf of you for any medical devices you own.
The Free Sale Certificate is a certification issued by a regulatory authority in an exporting nation based on the national laws proving that the product can be available in the country. However, it is with no proof that the product has been evaluated for efficacy or safety and has been registered to be used in the country.
The Certificate of Free Sale may also be commonly referred to as “Certificate for Export” or “Certificate to Foreign Governments.” It provides a guarantee by a foreign government agency that the products mentioned on the certificate can be freely produced and sold by the country looking to export a specific product or medical device or product.
A candidate may make requests for certificates of sale at no cost with the intention of export to:
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- General Medical Device(S)
- Active Implantable Medical Device(S)
- In-Vitro Diagnostic Medical Device(S)
- A Mixture of the Above Devices
CFSs are issued by the European Competent Authority upon request by an authorized representative of a manufacturer of medical devices. The FSC for Medical Devices is a proof that the medical device is legally advertised within the European Union.
There are a variety of certificates of sale for free that are issued according to one of the categories. Every certificate issued is in the context of a particular medical device or product. The contents will differ based on whether the products are CE registered or not and if the person applying for the certificate is a manufacturer, authorized representative or a legitimate manufacturer.
The MHRA (relevant EU Ministries’ Health & Regulatory Authority) is able to issue a certificate of sale for free: – where evidence of manufacture has been supplied for the product in question.
If the manufacturer is accredited to produce products that bear the CE mark, in the event that it is applicable
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- If the authorized representative or legally authorized manufacturer are situated within the EU
- If the device is not CE labeled for the purpose of sale outside the EU,
- The manufacturer must show the CE certified equivalence of their medical device at issue.
- The CFS can be issued by the EU Responsible Person
The responsible person (RP) is an individual who is legal or natural situated in the EU accountable for ensuring the products it sells remain safe, and that they are in complete conformity in accordance with Regulation. The RP can be easily identified since the address is clearly marked on the packaging.
As per the EU Regulations, each item/product has to be inspected to ensure its safety, qualified safety assessor prior to it is released to the general public. An RP is also required to make sure that the product is made in compliance with Good Manufacturing Practices. This applies regardless of whether the product been manufactured by an outside company like an independent manufacturer. Information about the product, its manufacturing method and its safety assessment should be available at all Competent Authorities of the Member State in which the RP is situated.
Certificate of Free Sale issued centrally within that country RP, regardless of the manufacturing location, is the norm.
CFS is a document that can be requested by the RP by its subcontractors, or consultants.
CFS is issued on behalf of the CFS is issued by the EU Responsible Person
A Responsible Person (RP) is an individual who is legal or natural situated in the EU, responsible for ensuring the products it sells have been tested and are in total conformity in accordance with Regulation. The RP is easily identified as the address is clearly marked on the packaging.
In accordance with the EU Regulations, each item/product is evaluated to ensure its safety to certified safety assessor prior to when it is released to the general public. It is the RP is also accountable to make sure that the product is made in compliance with Good Manufacturing Practices. This is true even if the product been manufactured by an outside company like an independent manufacturer. Information about every product, including the method of manufacturing it and safety evaluation, should be available at authorities. Competent Authorities of the Member State in which the RP is situated.
CFS issued centrally CFS issued centrally within that country RP, regardless of the production location, is the norm.
CFS is a document that can be requested by the RP by its subcontractors, or consultants.
ASCENT EMIRATES HAS THE RESOURCES AND EXPERIENCE TO SECURE YOUR CFS:
We can source a suitable Authorized Rep (EU Responsible Person) and MHRA Certification for thousands of medical device companies selling their products across Europe. We could obtain a Free Sale Certificate for Medical Devices from the Competent Authority in any of the EU countries as effectively and swiftly as is possible.
- We provide associate European Authorized Representative EU REP services since 2007.
- We are a part of both Europe and many of the markets which require CFS.
- Our long-standing relationships with the EU Competent Authority ensure efficient CFS procurement.
FOLLOWING DOCUMENTS ARE REQUIRED FOR ISSUING A FREE SALE CERTIFICATE:
- The application should be in the form of a Descriptive Cover Letter.
- Copy of the current manufacturing licenses
- A list of items for which a certificate is required
- Copies of the product authorization letters for the products requested for the issue of an FSC
- Affordable Application Fee, a certificate that contains items in one certificate Representation Fees.
- The letter of the authority concerned, requesting the certificate
- Copy of the power of attorney/authorization letter
The documents and fees provided are just an indication. The list may alter based on the requirements of regulatory authorities at any time.
