USFDA (the Food and Drug Administration) is an agency of the United States responsible to protect and regulate public health products, such as medical products, tobacco, food, veterinary medicines.
The USFDA regulates all the processes for drugs and medical supplies, such as testing, manufacturing, labeling, advertising, safety.
The CDRH is the FDA branch responsible for the approval of medical devices. CDRH regulatory powers include the authority to require certain technical reports from the manufacturers or importers.
For all medical devices imported in the United States, such as our condoms, is mandatory that the products are USFDA certified, as a prove of high quality standards.
Learn More: https://www.fda.gov/
CE is an abbreviation for Conformite Europeenne (European Conformity) and the mark indicates that all the requirements for the specific product meet the European standards and that it has been tested and allowed to enter the European market.
The CE mark is mandatory for certain products to be sold in Europe since 1985, and is a symbol the free marketability of the product in the EU.
The manufacturer and the importer must ensure that the good meets all the standards. The manufacturer that affixed the CE mark has to follow some mandatory steps before the good can be CE certified and the importers have to verify that all these steps have been successfully passed.
CE mark is misused: it is sometimes affixed to products that do not meet the European standards, oraffixed to products that do not require it.
ISO (International Organization for Standardization) 13485:2003 standard represents the quality management system for design and manufacturing of medical devices; it was published in 2003.
This international certification requires the manufacturer the quality system of the facilities.
The most important objective of this standard is to harmonize medical devices quality standards, like implementation of a quality management system, risk management approach, effective product traceability.
Some of the benefits of ISO 13485:2003 are customers satisfaction and safety, reducing operating costs, improved risk management.
It is relevant to all the manufacturers that wish to demonstrate applicable regulatory requirements and product high quality standards.
Being an ISO 13485:2003 certified manufacturer is mandatory to successfully register products in a lot of countries. However many countries require additional QMS requirements.
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