For more details on medical device registration in Japan, visit [ Ссылка ]
The Ministry of Health, Labor, and Welfare (MHLW) is the primary regulatory body in Japan. that creates and implements safety standards for both medical devices and drugs.
The Pharmaceutical Medical Devices Agency (PMDA) works with the MHLW, in order to ensure both the safety and quality of medical devices and drugs in Japan and is a technical arm of the MHLW.
Foreign manufacturers intending to manufacture drugs, quasi-drugs, Active Pharmaceutical Ingredients (APIs), or medical devices overseas and plan to import into Japan, need to register with the Ministry of Health, Labor, and Welfare (MHLW). This process is known as Foreign Manufacturer Registration (FMR), and Toroku in Japanese.
Previously FMR was known as Foreign Manufacturer Accreditation (FMA).
All the foreign companies who intend to register their medical device with the Ministry of Health, Labor, and Welfare (MHLW) need to follow 8 steps of approval.
Step 1 - Establish QMS requirements,
Step 2 - Obtain necessary authorizations and licenses,
Step 3 - Foreign Manufacturer Registration (FMR),
Step 4 - Categorize the medical device,
Step 5 - Authorization procedure selection,
Step 6 - Submit the authorization documents,
Step 7 - Request a QMS Inspection, and
Step 8 - Plan the post-market period.
Classification of the medical device in Japan
Class I devices
- The devices come under Class I when the risk to patients is almost negligible in the event of a malfunction (ex. X-ray films).
- These classes of devices are also known as General Devices.
Class II devices
- The devices come under Class II when the risk to patients is relatively low in the event of a malfunction (ex. MRI, digestive catheters, etc.).
- These devices are also known as Controlled Devices.
Class III devices
- The devices come under Class III when the risk to patients is relatively high in the event of a malfunction (ex. artificial bones, dialyzer, etc.).
- These devices are also known as Specially Controlled Devices.
Class IV devices
- These devices are highly invasive with fatal risks to patients (ex. pacemaker, artificial heart valves, etc.).
- These devices are also known as Specially Controlled Devices.
Japan Medical Device Nomenclature (JMDN) codes
The Ministry of Health, Labor, and Welfare (MHLW) maintains a database of generic device descriptions associated with Japan Medical Device Nomenclature (JMDN) codes.
This JMDN system is similar to the Global Medical Device Nomenclature (GMDN) system or the US FDA nomenclature system.
If the Ministry of Health, Labor, and Welfare (MHLW) database does not contain the device code, then the product needs to undergo a new registration pathway based on the class to which the device belongs.
