A Certificate of Free Sale (CFS)/ Free Sale Certificate (FSC) is issued by regulatory authorities of a country to foreign agency as an assurance. CFS also sometimes called as "Certificate for Export" or "Certificate to Foreign Government".  Its an evidence of that the products, such as medical devices, Food, Pharmaceutical etc are legally sold in open market without any restriction.  A CFS also declares that the medical device has CE marked under one of the medical device directives.  If your foreign customer requests for a Certificate of Free Sale (CFS), you can apply through Antex.  Antex Medi Solution able to provides important documents required for CFS when manufacture appointed us as EC Rep.   In many cases, a Certificate of Free Sale is need to be approved by the Ministry of Health/Foreign Affairs office and attested by a country’s Embassy/Consulate. Again, Antex Medi Solution is able to facilitate this requirement.  

European Authorised Representative (EC Rep) serves as a legal entity to provide a point of contact between you (non- European manufacturer of medical device) and the Notified Body (NB). All communication with the authorities is required to be done via the Authorized Representative. Manufacturer of goods especially of medical devices must require a EC Rep along with CE mark of all products in order to carry out applicable registration with National Competent Authority. Authorised Representative (EC Rep) performs product registration into relevant data base of the European Countries and EU Member States. The European Authorised Representative assists manufacturers in all aspects of the necessary vigilance requirements such as incident reporting. Authorised Representative (EC Rep) have great responsibilities according to MDR (EU) 2017/745 so, you can expect your representative to scrutinise your documentation more thoroughly. Antex as EC Rep operate exactly according to MEDDEV 2.5/10.   

After No-deal Brexit, Medicines and Healthcare products Regulatory Agency (MHRA) created a role under the UK MDR 2002 (as amended by the UK MDR 2019). According to this role it becomes mandatory for manufacturers of medical devices (those who are not established in the UK) to designate a ‘UK Responsible Person’ to act on their behalf and to legally place medical devices in the British market.  According to the UK MDR 2019 the UK Responsible Person is defined as “a person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations” A UK Responsible Person has responsibilities to provide all the information and require documentation to MHRA in order to demonstrate the conformity of a medical device.  Antex can offer you a UK Responsible Person Service in order to meet the demands of the changes inflicted on you following Brexit. 

The U.S. Food and Drug Administration (FDA) requires all medical device companies without a presence in the United States to designate a registered US FDA Agent. US Agent serves as a liaison between your company and the FDA.  According to FDA the  responsibilities of a U.S. Agent are  assisting FDA in communications with the foreign establishment, responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States, assisting FDA in scheduling inspections of the foreign establishment and if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment. Antex offers you a well experienced U.S. Agent, who will assist you with FDA registration and guideline.