Pharmaceuticals and Medical Device Law (PMDL)
Mandatory Medical Device Approval
Certification of Medical Devices pursuant to the Pharmaceuticals and Medical Devices Law
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 PAL Certification Scope* As of March 30, 2016
Highly-controlled Medical Devices
- Electrosurgical units utilizing argon plasma; Active instruments for medical procedures utilizing argon plasma
- Anesthesia depth patient monitors; Central unit patient monitors with analytic capability; Cardiac arrhythmia patient monitoring systems; Multiparameter patient monitors with important parameters; Apnea monitors; Apnea alarms; Electrocardiographic modules with arrhythmia analysis function; Electrocardiographic/respiratory modules; Nerve detection modules; Intracranial pressure modules
- Insulin pens
- Heparin-coated arterial line blood filters for use in cardiopulmonary bypass circuits; Heparin-coated, single-use cardiopulmonary bypass defoamers
- Enteral infusion pumps, general-purpose infusion pumps, syringe infusion pumps, patient-controlled analgesia infusion pumps
- Reusable manually-operated pulmonary resuscitators; Single-use manually-operated pulmonary resuscitators
- Non-sterile silk sutures; Sterile silk sutures; Polyester sutures; Polyethylene sutures; Polypropylene sutures; Polybutester sutures; Polytetrafluoroethylene sutures; Plastic sutures; Polyamide sutures; Polyvinylidene fluoride sutures; Polyurethane sutures; Vinylidene fluoride/hexafluoropropene copolymer sutures; Stainless steel sutures; Titanium sutures
- Continuous positive airway pressure units; Continuous-automatic positive airway pressure units
- Self-use glucose meter kits
- Neurosurgical navigation units
Controlled Medical Devices
- Dental devices
- Inactive implantable devices
- Single-use devices
- Diagnostic radiological and imaging devices
- Anesthetic/respiratory devices
- Clinical equipment
- Reusable devices
- Hearing aids
- Active implantable devices
- Medical electrical devices
- Ophthalmic devices
- Home-use massage and therapeutic devices (and related items)
In-vitro Diagnostic Medical Devices
- In-vitro diagnostic medical devices
Certificates for Specified 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 PMDL Certification
ISO 13485 management system audits can be conducted at the same time as QMS audits for PMDL certification.
The PMDL 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 PMDL QMS Ordinance.
* Contact us if you wish to utilize ISO 13485 certification issued by another certification body.