info@wiselink.com.au
1300 76 80 90
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
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Compliant with ISO 13485 requirements
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Importer/Distributor must be legally registered in Japan and hold a Marketing Authorization Holder (MAH) license
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Timeframe: 1 month
Class II
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ISO 13485 Certification
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Declaration of Conformity
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Importer/Distributor must be legally registered in Japan and hold a Marketing Authorization Holder (MAH) license or a Designated MAH (D-MAH)
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Timeframe: 3-9 months
Class III
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ISO 13485 Certification
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Declaration of Conformity
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Importer/Distributor must be legally registered in Japan and hold a Marketing Authorization Holder (MAH) license or a Designated MAH (D-MAH)
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Timeframe: 9-11 months
Class IV – Highest Risk
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ISO 13485 Certification
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Declaration of Conformity
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Importer/Distributor must be legally registered in Japan and hold a Marketing Authorization Holder (MAH) license or a Designated MAH (D-MAH)
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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.
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Looking to register your medical device in Japan? Contact us today!
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