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Medical Device Registration Services - Japan

Regulatory Department

The Pharmaceuticals and Medical Devices Agency (PMDA), under the Ministry of Health, Labour and Welfare (MHLW) 

Regulation

Pharmaceutical and Medical Device Act (PMD Act)

Regulatory Classification & Registration Process

Class I – Lowest Risk

  • Compliant with ISO 13485 requirements

  • Importer/Distributor must be legally registered in Japan and hold a Marketing Authorization Holder (MAH) license

  • Timeframe: 1 month

Class II

  • ISO 13485 Certification

  • Declaration of Conformity

  • Importer/Distributor must be legally registered in Japan and hold a Marketing Authorization Holder (MAH) license or a Designated MAH (D-MAH)

  • Timeframe: 3-9 months

Class III 

  • ISO 13485 Certification

  • Declaration of Conformity

  • Importer/Distributor must be legally registered in Japan and hold a Marketing Authorization Holder (MAH) license or a Designated MAH (D-MAH)

  • Timeframe: 9-11 months

Class IV – Highest Risk

  • ISO 13485 Certification

  • Declaration of Conformity

  • Importer/Distributor must be legally registered in Japan and hold a Marketing Authorization Holder (MAH) license or a Designated MAH (D-MAH)

  • Timeframe: 13-16 months

* A Japanese representative with MAH or D-MAH licence is required to represent overseas medical device manufacturers. We will be able to manage this for you.

Looking to register your medical device in Japan? Contact us today!

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