Pharmaceuticals and Medical Device Law (PMDL)
Mandatory Medical Device Approval
Pharmaceuticals and Medical Devices Law
Medical device certification under the PMDL*1 is a third-party certification of applicable medical devices*2 conducted by certification bodies registered under the Ministry of Health, Labor and Welfare (MHLW).
- *1 The law's full name in Japanese translates to "Law to Ensure Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, and Similar Products," but is often shortened to "Pharmaceuticals and Medical Device Law" or PMDL.
- *2 Applicable medical devices refers to those Class II and Class III devices and IVDs that have third-party certification requirements specified by MHLW (excluding IVD MDs that are radiopharmaceuticals).
Classification of medical devices:
- Class I: General Medical Devices (notification is required)
- Class II: Controlled Medical Devices (specified products require certification by a third-party, all other products require government approval)
- Class III: Highly-controlled Medical Devices (specified products require certification by a third-party, all other products require government approval)
- Class IV: Highly-controlled Medical Devices (government approval is required)
Obligations of Marketing Authorization Holders (MAH) and Manufacturers
Marketing Authorization Holders (MAHs) must obtain Marketing Authorization from a registered certification body (RCB) before specified controlled medical devices may be sold in Japan.
The chart below shows where to submit applications for each type and class of medical device/in-vitro diagnostic medical device.
|Class||Japanese Classification||Pre-market Requirement||Manufactured in Japan||Manufactured Overseas||MAH|
|IV||Highly-controlled Medical Devices||Approval||Pharmaceutical and Medical Devices Agency (PMDA)||Pharmaceutical and Medical Devices Agency (PMDA)||Permission Required|
|III||Highly-controlled Medical Devices||Approval||PMDA||PMDA||Permission Required|
|Specified Highly-controlled Medical Devices||Certification||Registered Certification Body(RCB)||Registered Certification Body(RCB)|
|II||Controlled Medical Devices||Approval||PMDA||PMDA||Notification Required|
|QMS||Local Authority Note 1||PMDA|
|Specified Controlled Medical Devices||Certification||RCB||RCB|
|I||General Medical Devices||Notification||PMDA||PMDA||N/A|
|II||Specified In-vitro Diagnostic Medical Devices Note 2||Certification||RCB||RCB||Notification Required|
- Note 1: QMS Audit Agency
- Note 2: Excluding IVD MDs that are radiopharmaceuticals