For most devices with generic names, PMDA issues so-called “Criteria.” “Criteria” is equivalent to technical standards such as ISO or JIS and in most cases, medical device manufacturers are able to obtain medical device approvals by having their products comply with the “Criteria.”

On 31st August 2023, PMDA revised "Criteria" for the following Class III devices:


Sterile anesthesia needle

Spinal anesthesia needle

Epidural injection needle

Epidural anesthesia catheter

Automated peritoneal dialysis system

Hemodialysis system