1. eu CE certification, a pass to enter the eu market. It is mandatory by the EU that medical devices exported to the EU cannot be cleared through customs without ce, and CE compliance reports are issued for low-risk products of Class I, CE certificates are required for high-risk products of Class I*, IIA, IIB and III, and CE marks are affixed to the product packages. Now, CE applications for medical products should comply with MDR regulations.
2.EC-REP is usually associated with CE certification. I*, IIA, IIB and III high-risk products need to provide European information when applying for CE. There is no mandatory provision for Class I products, but EU customers generally require enterprises to provide European information.
3. EU registered with the US Food and Drug Administration (MHRA registered in the UK), some non-EU countries will require it, and some countries in the Middle East and South America, such as Egypt, Saudi Arabia, United Arab Emirates, Argentina and Colombia.
4. EU Free Sales Certificate CFS Certificate: A free sales certificate required by non-EU countries has now become a compulsory certification for countries in the Middle East and South America.
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6. US FDA registration, FDA5 10K, FDA factory inspection. For the US market, FDA registration is mandatory. Ordinary FDA registration and product listing are aimed at general low-risk products, which are called 5 10K exempted products in the industry, and 5 10K corresponds to high-risk products, which is what we call 5/KLOC-0. The FDA's factory inspection is aimed at some enterprises that have been spot-checked. The higher the risk of general products, the greater the probability of being drawn for factory inspection.