EEA member states and other individual countries within the body (some even local civil manufacturers' associations) in order to promote the national (locally) manufactured products exported to other third countries outside the EEA for the local manufacturers to issue a free sales certificate, which is to prove that their products meet the requirements of the relevant EC directive can be in the EEA. In order to promote the export of locally manufactured products to other third countries outside the EEA, local manufacturers are issued with a Free Sale Certificate, which certifies that their products meet the requirements of the relevant EC Directives and can be sold freely within their own country (locally). The only body authorized and qualified by the EC Directive to issue an EU Free Sale Certificate should be the Competent
Authorities
(Cas) of the medical device authorities of the EEA Member States. With the CE marking and the relevant directives required in the EU registration, Chinese manufacturers export to the EU does not require a free sale certificate, when you hold a CE certificate to other non-EU countries to register, some governments and will require you to provide the EU government issued a free sale certificate.
The process of applying for a Free Sale Certificate:
1.
Preparation of documents (including CE certificates, documents, corporate information, etc.)
2. Submission of information to the competent authorities of the EEA member states by the EEA representative (DH for the United Kingdom)
3. Issuance of the certificate
4.
Notarization of the embassy
This is the first time that the EEA has issued a Free Sale Certificate in the United States. >
The U.S. Food and Drug Administration (full name: Food and Drug Administration, abbreviation: FDA), FDA
is one of the executive agencies of the U.S. government established in the Department of Health and Human Services (DHHS) and the Department of Public **** Health (PHS). As a scientific regulatory agency, FDA
is responsible for ensuring the safety of food, cosmetics, drugs, biologicals, medical devices, and radiological products manufactured in or imported into the United States. It was one of the first federal agencies whose primary function was to protect consumers. The agency is relevant to the lives of every U.S. citizen; internationally, the FDA is recognized as one of the world's largest food and drug regulatory agencies; and many other countries seek and receive help from
FDA
to promote and monitor the safety of their products.
The FDA regulates medical devices through the Center for Devices and Radiological Health (CDRH), which oversees the manufacturing, packaging, and distribution of medical devices in compliance with the law.
Medical devices range from small medical gloves to large cardiac pacemakers, and are all under FDA oversight. Based on their medical use and possible harm to the human body, the FDA categorizes medical devices into Class I, II, and III, with the higher the category the more oversight.
If the product is a novel invention that does not exist in the marketplace, the FDA requires the manufacturer to conduct rigorous human trials and have compelling medical and statistical evidence of the product's effectiveness and safety.
Medical device FDA certification, including: manufacturers in the FDA registration, product FDA registration, product listing registration (Form 510 registration), product marketing review and approval (PMA review) of healthcare device labeling and technical modifications, customs clearance, registration, pre-market report, must submit the following materials: (1) five copies of the finished product with complete packaging, (2) the device construction diagram and its Text description, (3) performance and working principle of the device, (4) safety demonstration or test material of the device, (5) brief description of the manufacturing process, (6) summary of clinical trials, (7) product specification. If the device has radioactive energy or release of radioactive material, must be described in detail.