The Requirements of Importing Dental Equipment(3/3)

Korea

KFDA registered in Korea

The Ministry of Health and Welfare (MHW), referred to as the Ministry of Health, is responsible for the management of food, drugs, cosmetics and medical devices including dental equipment, and is the main health care department.

The Korean Medical Devices Act classifies medical devices into 4 categories (I, II, III, IV), and this classification is very similar to that of the EU for medical devices.

Class I: medical devices with little or no potential hazard.
Class II: medical devices with low potential hazards.
Class III: medical devices with moderate potential hazards.
Class Ⅳ: high-risk medical devices

Process for KFDA registration

1. Determine the product classification (I,II,III,IV) and select KFDA KLH.
2. Class II products need to apply for KGMP certificate and undergo on-site audit, Class II products are generally authorized third party auditors and obtain KGMP certificate.
3. Class II products need to send samples to the authorized laboratory of MFDS in Korea for testing of Korean standards.
4. Submission of technical documents (test report, KGMP certificate, etc.) by Korean agent to MFDS for registration approval.
5. Payment of application fees.
6. Rectification of registration documents and registration approval.
7. Appointment of Korean agents and distributors, product sales.

Japan

PMDA Registration in Japan

Medical device companies wishing to launch their products into the Japanese market must meet Japan’s Pharmaceutical and Medical Device Act (PMD Act), but language issues and complicated certification procedures are still a difficult point for medical device registration in Japan.

Under the PMD Act, the TOROKU registration system requires domestic manufacturers to register factory information, including product design, production, and critical process information, with the government-authorized local authorities; foreign manufacturers must register manufacturer information with PMDA.

Process for PMDA registration

1. Preparation stage. Determining the product classification (I,II special control, Class II control,III,IV) and the product JMDN code, and selecting the day generation MAH.
2. Registration of the plant by the manufacturer with PMDA.
3. QMS factory audit for Class II special control products to the authorized certification body PCB, and QMS factory audit for other Class II products and Class III IV products to PMDA and obtain QMS certificate.
4. Applying for a Pre-Market Apporval certificate, with Class II special control issued by PCB and other Class II products and Class III IV product control issued by MHLW.
5. Payment of application fees.
6. Rectification of registration documents and approval of registration.
7. All categories of products need to be registered by MAH to RBHW for import notification before they can be imported for sale.