Requirements and registration procedures for exporting medical devices in various countries
1. Europe: Free Sale Certificate
The only organization authorized and qualified by EU directives should be the Competent Authorities (CAS) of the EEA member states.
With the CE mark and the EU registration required by the relevant directives, Chinese manufacturers do not need a free sales certificate to export to the EU. When your CE certificate is registered in other non-EU countries, some governments will require you Provide a free sale certificate issued by the EU government.
2. United States: FDA registration
The US FDA stipulates that foreign medical equipment, food, alcohol, pharmaceuticals and other factories must be registered before entering the United States. At the same time, an American agent must be appointed who is responsible for emergency and daily affairs communications.
3. Australia: TGA registration
TGA is the abbreviation of Therapeutic Goods Administration, which is the supervision agency for Australia’s therapeutic products (including drugs, medical devices, genetic technology and blood products). Australia’s classification of medical devices is almost the same as that of the European Union.
If you have obtained the CE certificate issued by the Notified Body of the European Union, it can be recognized by the TGA and can be used as an important registration material to meet the Australian safety regulations.
4. Canada: CMDCAS
All medical devices sold in the Canadian market, whether they are locally produced or imported in Canada, must be approved by the Canadian medical device authority-Health Canada for evaluation based on CMDCAS.
Health Canada requires all medical device manufacturers selling in the Canadian market to have a CMDCAS (Canadian Medical Device Conformity Assessment System) certification and registration certificate to prove compliance with Canadian medical device regulations. Canadian medical management implements a product registration system.
Different from the United States and Europe’s inspection system (CE certification), Canada implements government registration combined with a third-party quality system review. The third party mentioned here refers to a third-party organization accredited by the Standards Council of Canada (SCC) that can conduct the audit of the Canadian medical device conformity assessment system.
Medical devices are divided into four categories: I, II, III, and IV according to their use risks. For this reason, the product registration requirements for manufacturers have also been gradually increased, and the system that manufacturers are required to implement is more and more detailed.
5. South Korea: KFDA registration
The Ministry of Health and Welfare (MHW) of South Korea is mainly responsible for the management of food, medicine, cosmetics and medical equipment, and is the most important health care department.
According to the “Medical Devices Act”, the Ministry of Food and Drug Safety under the Ministry of Health and Welfare of Korea is responsible for the supervision of medical devices.
6. Japan: PMDA registration
Medical device companies wishing to put their products on the Japanese market must comply with Japan’s Pharmaceutical and Medical Device Act (PMD Act), but language issues and complicated certification procedures are still a difficult point for Japanese medical device registration.
Under the requirements of the PMD Act, the TOROKU registration system requires domestic manufacturers to register factory information with the local competent authority authorized by the government, including product design, production, and key process information; foreign manufacturers must register manufacturer information with PMDA .