Freyr Solutions Japan

Freyr Solutions Japan:

Business Description

Though the market looks promising, the major barrier in obtaining medical device approval in Japan market is the stringent Pharmaceuticals and Medical Devices Agency (PMDA) regulations that companies must abide by. To manage their product registrations and liaise with Japan’s regulatory authorities, all foreign medical device and pharmaceutical companies selling in Japan must assign a Japan DMAH agent. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) working under the Ministry of Health Labour and Welfare (MHLW) Regulation: Pharmaceuticals and Medical Devices Act (PMD Act) Regulatory Pathway: Pre-Market Submission or Pre-Market Certification or Pre-Market Approval Authorized Representative: MAH/D-MAH QMS Requirement: Ordinance No. 169, MDSAP Certification

Location

Asahi-Ku Nishikawashimacho 7-8, Japan

Storeboard City

Yokohama, Japan | Contact This Member

Directory Category

Business Consultants | Business Consultants Network

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