Pharmaceuticals and Medical Device Agency

Basic concept for medical device regulation in Japan

Medical devices is regulated by the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (hereinafter referred to as “the Pharmaceuticals and Medical Devices Act) , which came into effect in November 2014 (See Table 1) , and classified by risk base concept.

[Table 1] Classification and Regulation regarding Medical Devices

GHTF Classification		Pharmaceutical and Medical Devices Act
		Category	Regulatory requirements
Class A	Extremely low risk e.g., X-ray film	General MDs (Class I)	Self declaration Approval of the product is not required, but marketing notification is necessary.
Class B	Low risk e.g., MRI, digestive catheters	Controlled MDs (Class II)	Third party Certification Certification by a registered certification body is required. ・Certification Criteria	Minister’s Approval (Review by PMDA) The Minister's approval for the product is required. ・Approval Criteria ・Review Guideline
Class C	Medium risk e.g., dialyzer	Specially Controlled MDs (Class III & IV)
Class D	High risk e.g., pacemaker		Minister’s Approval (Review by PMDA) The Minister's approval for the product is required. ・Approval Criteria ・Review Guideline

Each device is reviewed depending on its specific risk to the human body in case of problems happened.

1. For review of general medical devices, a self-declaration system is adopted.

2. Designated Controlled Medical Devices are to be certificated by the third-party certification bodies based on Certification Criteria (discussed below) which are pre-authorized by the Minister of Health, Labor and Welfare (hereafter MHLW). Other Controlled Medical Devices are reviewed by the Pharmaceuticals and Medical Devices Agency (hereafter PMDA).

3. Specially Controlled Medical Devices are to be reviewed by PMDA and approved by the MHLW. They are reviewed based on separately specified approval criteria or Guidance Documents which are authorized by the MHLW. Where some devices comply with specified certification criteria and authorized by the MHLW they are to be reviewed and certificated by the third-party certification bodies as a designated Specially Controlled Medical Devices.

PMDA classify the reviewing applications for medical devices are as follows:

1. New medical devices

Marketing applications for medical devices that have a clearly different structure, usage, indication, performance, etc., as compared to those which have already been approved for marketing (excluding devices subject to use-results survey specified in Article 23-2-9, Paragraph 1 of the Pharmaceuticals and Medical Devices Act and the survey is ongoing; hereafter "existing approved medical devices")

2. Improved medical devices (with clinical data)

Marketing applications for medical devices that do not fall under "new medical devices" or "generic medical devices"

3. Improved medical devices (without approval criteria, without clinical data)

Marketing applications for medical devices that do not fall under "new medical devices" or "generic medical devices" (limited to devices for which no clinical data are required to be submitted.)

4. Generic medical devices (without approval criteria, without clinical data)

Marketing applications for medical devices that are regarded as substantially equivalent to existing approved medical devices in terms of structure, usage, indications, performance, etc. (limited to devices for which no clinical data are required to be submitted.)

5. Generic medical devices (with approval criteria, without clinical data)