Basic concept for Approval and Certification for Medical Devices

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 gthe 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
International Classification Risk base Medical Device Classification Classification Risk Level Type of regulation
Class T Devices with extremely low risk to the human body in case of problems
Examples: In vitro diagnostic devices, steel made small devices (including a scalpel, tweezers), X-ray film, devices for dental technique
General
Medical
Device
Extremely low Approval/certification not required
(Notification/self declaration)
Class U Devices with relatively low risk to the human body in case of problems
Examples: MRI devices, electronic endoscope, catheter for digestive organs, ultrasonic devices, dental alloy
Controlled
Medical
Device
Low Certification by third party certification
(limited to devices for designated controlled Medical Device, complying with certified standards)
Approval by the Minister of Health, Labor and Welfare
(reviewed by PMDA)
Class V Devices with relatively high risk to the human body in case of problems
Examples: Dialyzer, bone prosthesis, mechanical ventilation
Specially
Controlled
Medical
Device
Medium
/
High
Class W Devices highly invasive to patients and with life-threatening risk in case of problems
Example: Pacemaker, artificial cardiac valve, stent graft
Approval by the Minister of Health, Labor and Welfare
(reviewed by PMDA)

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 Mmedical Ddevices are to be certificated by the third-party certification bodies based on Certification Standards (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 Minister of MHLW. They are reviewed based on separately specified approval standards or Guidance Documents which are authorized by the MHLW. Where some devices comply with specified certification standards 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 standards, 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 standards, 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 standards, 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.) and that comply with approval standards (discussed below)




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