Compliance with Japan's PMDA Medical Device and Pharmaceutical/Drug Regulations
The Ministry of Health, Labor and Welfare (MHLW) along with the Pharmaceuticals and Medical Devices Agency (PMDA) are responsible for regulating medical products in Japan.
The main regulations for medical devices and pharmaceuticals are as follows:
- Revised Pharmaceutical Affairs Law (PAL)
- Ministerial Ordinance No. 179 on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs (GMP)
- Ministerial Ordinance No. 169 on Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents (QMS)
- Ministerial Ordinance No. 136 on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices
Pacific Bridge Medical can make sure you comply with all the appropriate regulations by providing GMP audits for your drug, QMS audits for your medical device, and FMA document review. We can also register your medical product and develop the appropriate regulatory strategy in Japan.
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