The Requirements of Importing Dental Equipment(1/3)

Europe

EU Free Sale Certificate

The only authorized and qualified by the EU Directive to issue the EU Free Sale Certificate should be the Competent Authorities for Medical Devices (Cas) of the EEA member states.

With the CE mark and the EU registration required by the relevant directives, Chinese manufacturers exporting to the EU do not need a free sale certificate, but when you hold the CE certificate to register in other non-EU countries, some national governments will require you to provide a free sale certificate issued by the EU government.

Process for Free Sale Certificate

1. Prepare documents (including CE certificate, documents, enterprise information, etc.).
2. Submission of the information by the European representative to the competent authorities of each EEA member state.
3. Issue the certificate.
4. Embassy notarization.

U.S.

FDA Registration for Import into the U.S.

The U.S. FDA requires that foreign factories of medical devices, food, alcohol, and drugs must be registered before entering the U.S. and must also appoint a U.S. agent who is responsible for emergency and day-to-day communication of matters.

Registration process of FDA

1. Determine the classification of the product. In accordance with CFR TITLE 21 parts 862-892 most of the medical devices can be classified in accordance with this classification code for product classification.
2. Select a U.S. agent (US AGENT).
3. Registration preparation. 1 category of products are directly subject to factory registration and product listing; 2 category of products require preparation of 510(k) documents.
4. Submit the 510(k) file to FDA for document review.
5. Factory registration and product listing.

Australia

TGA registration for Import to Australia

TGA is the abbreviation of Therapeutic Goods Administration, the full name is Therapeutic Goods Administration, which is the supervisory body of therapeutic goods (including drugs, medical devices, genetic technology and blood products) in Australia.

Australia classifies medical devices into Class I, Is and Im, IIa, IIb, III. The classification of products is almost the same as the EU classification, if your company’s products have already obtained the CE mark, the product category can be classified according to CE.

If you have already obtained the CE certificate issued by the EU Notified Body, it can be recognized by TGA and can be used as important registration information to meet Australian safety regulations. (Refer to CE certification for specific process)