Act on Pharmaceuticals and Medical Devices (PMD Act)
Mandatory Medical Device Approval

Certification of Medical Devices pursuant to the Act on Pharmaceuticals and Medical Devices (PMD Act)

JQA became a registered certification body under the Ministry of Health, Labor and Welfare on April 1, 2005 and conducts certification pursuant to PMDL (RCB ID: AH).

JQA's PMD Act Certification Scope* As of August 27, 2022

Specially-controlled Medical Devices

  • Material combined electrosurgical unit; Material-combined procedure active instrument
  • Anaesthesia depth monitor; Central monitor with analytic capability; Cardiac arrhythmia monitoring system; Multiparameter monitor with critical parameters; Apnoea monitor; Apnoea alarm; Electrocardiographic module with arrhythmia analysis function; Electrocardiographic/respiratory module; Nerve detection module; Intracranial pressure module
  • Reusable insulin pen injector
  • Heparin-coated heart-lung bypass circuit filter; Heparin-coated single-use heart-lung bypass defoamer
  • Enteral feeding infusion pump; General-purpose infusion pump; Syringe infusion pump; Patient-controlled analgesic infusion pump
  • Reusable manually-operated pulmonary resuscitator; Single-use manually-operated pulmonary resuscitator
  • Non-sterile silk suture; Sterile silk suture; Polyester suture; Polyethylene suture; Polypropylene suture; Polybutester suture; Polytetrafluoroethylene suture; Plastic suture; Polyamide suture; Polyvinylidene fluoride suture; Polyurethane suture; Vinylidene fluoride/hexafluoropropene copolymer suture; Stainless steel suture; Titanium suture
  • Continuous positive airway pressure unit; Continuous-automatic positive airway pressure unit
  • Self monitoring glucose meter
  • Neurolosurgical navigation unit

Controlled Medical Devices

  • Dental devices
  • Non-active implantable devices
  • Single-use devices
  • Radiation and diagnostic imaging devices
  • Anaesthesia/respiratory devices
  • Facility equipment
  • Reusable devices
  • Hearing aids
  • Active implantable devices
  • Medical electrical devices
  • Ophthalmic and visual devices
  • Massager and electric therapy apparatus for home use devices (and related items)

In-vitro Diagnostics

  • In-vitro diagnostics

Certificates for Designated Controlled Medical Devices

As an RCB, JQA is able to issue certificates for the above medical devices. To determine compliance, JQA conducts conformity assessments for product requirements and QMS* audits (desktop audit or on-site audit) for factories.

* QMS: Quality Management System

Joint QMS Audits for ISO 13485 and PMD Act Certification

ISO 13485 management system audits can be conducted at the same time as QMS audits for PMD Act certification.

ISO 13485

The PMD Act QMS Ordinance was developed with consideration of ISO 13485. If you have ISO 13485 certification from JQA, it is possible to avoid an additional on-site audit for the PMD Act QMS Ordinance.

* Contact us if you wish to utilize ISO 13485 certification issued by another certification body.
ISO Certification Page