What certifications are required for mask export:
1. EU CE certification, a pass to enter the EU market, EU mandatory regulations, medical devices exported to the EU cannot be cleared without CE, Class I low Risk products must issue a CE compliance report. High-risk products in categories I*, IIA, IIB and III require CE certificates and a CE mark on the product packaging. Now CE for medical products must be applied for in accordance with MDR regulations.
2. EU representative service (EC-REP: representative in the EU) is usually associated with CE certification. High-risk products of categories I*, IIA, IIB and III need to be provided when applying for CE. There are no mandatory regulations for European brand information and Class I products, but EU customers generally require companies to provide European brand information.
3. European Medicines Agency registration (UK MHRA registration), some non-EU countries will require it, and some countries in the Middle East and South America, such as Egypt, Saudi Arabia, the United Arab Emirates, Argentina, Colombia, etc.
4. EU Free Sale Certificate CFS Certificate: Free Sale Certificate, required by non-EU countries, has now become a mandatory certification in the Middle East and South American countries.
5. ISO9001/ISO13485 certification (medical device quality management system certification) is a common requirement in the medical industry. Whether it is domestic sales or export, system certification is required. Medical device companies must pass ISO13485 certification.
6. U.S. FDA registration, FDA510K, and FDA factory inspection are for the U.S. market. FDA registration is a mandatory requirement. General FDA registration and product listing are for general low-risk products, which are called 510K in the industry. Exempted products, 510K corresponds to high-risk products, which are what we call 510k products. FDA factory inspections are targeted at some companies that have been randomly inspected. Generally, the higher the risk of the product, the greater the probability of being selected for factory inspection.
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