General Description
Launching a sales medical devices should be met with Pharmaceutical Affairs Law’s approval in Japan
Applicable products
According to Pharmaceutical Affairs Law annex 2 paragraph 4,medical devices are aim to diagnostic, Therapy and prevention of human or animals and aim to influence to function and anatomy of human or animals
Base on Pharmaceutical Affairs Law annex 2 paragraph 2 to 7, medical devices are classified as revels of MHLW
- Class I: organism investigation devices, medical microscope, Diagnostic X-ray, blood investigation, nebulizer
- Class II: MRI, electrical blood pressure. Electrical endoscope, supersonic wave diagnosis, dental alloy.
- Class III: electronic surgical instruments, intra ocular lens, medical cautery, suture, dental excision, pulmonary pleura, artificial bone and joint
- Class IV: investigation devices for internal organs, medical blowpipe and body fluids, science diagnostic devices.
Conformity assessment procedure.
To sale medical devices should obtain accreditation of foreign manufacturers and approval of foreign manufacturers.
Class I products : submit a notice (medical devices manufacture and sale approval)
Class II, III, IV products
Levels Classification Depend on risk elements Regulation Procedure
*In case of Class III and IV should approval from MHLW and Class I,II can be approved from Notified body which are accreditated by MHLW. In this case, products are applicable to medical devices which standard of JIS and notification restrictively (medical devices which are not yet established JIS standard among classified as Class II should be approved by MHLW)
- accreditation of foreign manufacturers
Application of Medical devices manufacture approval
- Clinical data needs : manufacture approval needs to Clinical data.
- Need Approval standard and not require clinical data: manufacture approval application (not confirmed approval standard medical devices or not conformity to approval standarsds medical devices).limits it does not need clinical data.
- Need Approval standard and not require clinical data: manufacture approval application for Medical device which have approval standards
- Highly management devices approval and accreditation standard is Not: there is no approval standards and manufacture approval application of medical devices(not require clinical data)
- Procedure of accreditation of foreign manufacturers
foreign manufacturer approval application
Gain manufacture Code No (locality government) --> foreign manufacturer approval application(PMDA) --> Approved
- document investigation (GQP,GVP)
- site investigation (document investigation if it is case of foreign manufacturer)
- foreign manufacture sale approval application
- Technical fie and validation of products, audit of stability, GMP and PDMA
In case of no comment, audit report and application be submitted to MHLW and approved from MHLW