Licensing and Authorization
Achieve shorter approval timelines and higher success rates.
Under Japan’s Pharmaceutical and Medical Device Act (PMD Act), medical devices distributed or sold within Japan are required to obtain approval or certification by device class from the PMDA or a Registered Certification Body (RCB).
However, according to Article 68 of the Act, in cases where a device must be used urgently for patient treatment, a physician may import and use the device under their responsibility. Such devices cannot be sold commercially and may only be used for limited patient treatment or research purposes.
Furthermore, to commercially distribute and sell devices within Japan, the following licensing and approval procedures are required.
Prepare and submit an application requesting approval to the Ministry of Health, Labour and Welfare.
Clinical trial data and other supporting documents are thoroughly reviewed to determine whether they were collected in accordance with the [Standards for Reliability of Application Data], based on Good Clinical Practice (GCP) as specified by the Ministerial Ordinance of the Ministry of Health, Labour and Welfare, to ensure that the product is scientifically and ethically reliable and that the trial was conducted in accordance with the study protocol.
Determine whether the facility has the capacity to manufacture and supply products and whether quality management is adequate.
This inspection ensures that the site can continue to produce and supply products reliably in the future.
After undergoing a series of extensive reviews listed above, approval is granted by the Minister of Health, Labour and Welfare in consultation with the advisory committee.
Types of Class-Specific Approval / Certification and Review Authorities
| Medical Device Classification | Type | Review |
|---|---|---|
| Class IV (High Risk): Highly Controlled Medical Devices Devices that may pose a direct threat to life if a malfunction occurs (Examples) Pacemakers, artificial heart valves |
Approval (Partially certified) |
Pharmaceuticals and Medical Devices Agency (PMDA) |
| Class III (Medium Risk): Highly Controlled Medical Devices Devices that are considered to have a relatively high risk to the body if a malfunction occurs (Examples) Dialyzers, artificial bones, ventilators |
||
| Class II (Low Risk): Controlled Medical Devices Devices considered to have a relatively low risk to the body even if a malfunction occurs (Examples) MRI, electronic endoscopes, gastrointestinal catheters |
Certification (Partially approved) |
Third-Party Certification Body （ARCB） |
| Class I (Minimal Risk): General Medical Devices Devices considered to have minimal risk to the body even if a malfunction occurs (Examples) X-ray films |
Notification |
