Regulations

Q: What is CE certification?

A: CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE marking is also found on products sold outside the EEA that have been manufactured to EEA standards. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area.

 

The CE marking is the manufacturer's declaration that the product meets EU standards for health, safety, and environmental protection.

Q: I heard that CE marks can be self certified, is this true?

A: Depending on the level of risk of the product, the CE marking is affixed to a product by the manufacturer or authorized representative who needs to ensure that the product meets all the CE marking requirements. In some cases, if a product has minimal risk, it can be self-certified by a manufacturer making a declaration of conformity and affixing the CE marking to their product. Self-certification exists only for products which have a minimal risk for their use, and this is foreseen in the relevant Directive according to the product "category".

Q: Which organisation issues CE certificates?

A: Notified bodies perform calibration, testing, auditing, inspection, and certification activities indicated in the conformity assessment procedures when a third party attestation is required. Notified bodies are designated by notified authorities (related ministries) in terms of the applicable directives, and communicated to the EC.

Notified bodies can deliver conformity assessment services within the EU or in third countries. They must provide information to the notification authority and market surveillance authorities and carry out their activities impartially, independently, indiscriminate, and competently. They should have accreditation as proof of their competence.

Q: What information should the CE mark provide?

A:The EU declaration of conformity must include: manufacturer's details (name and address, etc.); essential characteristics the product complies; any European standards and performance data; if relevant the identification number of the notified body; and a legally binding signature on behalf of the organization.

Q: What is the FDA?

A: FDA is the abbreviation of the US Food and Drug Administration. It is affiliated to the US Department of Health, Education and Welfare, and is responsible for the management of medicines, food, biological products, cosmetics, veterinary drugs, medical devices, and diagnostic supplies.

Q: Which organisation issues FDA certificates?

A: There is no official certificate for FDA registration issued by the FDA. If the product is registered with FDA, the registration number will be obtained. FDA will give the applicant a reply (with the signature of the FDA chief executive), but there is no FDA certificate as such. However organisations which facilitate the process do provide manufacturers with a certificate to show they have registered with them. 

Q: Does FDA registration need to be tested by a designated certificated laboratory?

A: The FDA is an enforcement agency, not a service agency. If someone says that they are FDA-certified laboratories, it is at least misleading consumers, because FDA has neither a service-oriented certification body and laboratory for the public nor a so-called "designated laboratory". As a federal law enforcement agency, the FDA cannot engage in such a matter of being a referee and an athlete. FDA will only recognize the GMP quality of service testing laboratories and issue qualified certificates but will not "designate" or recommend a specific company or companies to the public.

Q: What is the CFDA?

A: China’s State Food and Drug Administration (CFDA China, 国家药品监督管理局, renamed to National Medical Products Administration or NMPA China in 2018) is Chinese government’s administrative body responsible for regulating pharmaceuticals, medical devices, and cosmetics in China.

It is responsible for creating and supervising the implementation of policies, plans, and standards governing the quality and safety of drugs, cosmetics, and medical devices. NMPA also oversees standards-setting, registration, and quality management of drugs, cosmetics, and medical devices, as well as post-market inspection and risk management and registration of licensed pharmacists.

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