3 types of medical licenses for 4 classes of medical items
Although in Japan, there is only 1 type of license for Medical Device Manufacturer, 3 types of licenses for Medical Device Manufacturer and Seller are available. A Type 2 license is essential for regulated medical devices with potential risks to human health, such as physical therapy equipment, electronic endoscopes, and MRI machines. SK provides comprehensive services, including licensing, quality control, customs clearance, and warehousing for these medical items. Alongside the Medical Device Manufacturer License, we facilitate seamless import and export operations to and from Japan, offering customized support to fulfill your specific needs.
TYPE ONE
Items that have the potential to significantly impact human life and health.
Highly Controlled Medical Devices
- Dialysis machines
- Pacemakers
- Radiation therapy equipment
- Artificial heart valves
TYPE TWO
Items that require proper management due to the potential risk of affecting human life and health.
Controlled Medical Devices
- Physical therapy equipment
- Electronic endoscopes
- MRI machines
- Intestinal catheters
TYPE THREE
Items that are unlikely to affect human life or health even if they cause side effects or functional disorders.
General Medical Devices
- Medical diagnostic equipment
- Scalpels
- Forceps
- X-ray films
Medical Device Manufacturer
License ID: 13BZ201513
Medical Device Manufacturer & Seller (Type 2)
License ID: 13B2X10474
