Japanese Medical Device Inspection Guide, the working English translations of Japanese GMP regulations and guidances. This 120-page manual is all you need to ensure your facility can handle the scrutiny of a PMDA inspection.

Place your order today and get:

• Which quality subsystems will always be inspected in a PMDA inspection and which may be omitted
• Factors used in the PMDA risk assessment that establish which companies will be inspected
• Requirements for all quality systems under Japan's GMPs
• Facility requirements for medical device manufacturers
• Timelines for Japanese medical device GMP inspections

Japanese Medical Device Inspection Guide will help you meet Japan’s GMP requirements and ensure your access to that lucrative market. The official documents that have been translated into English include:

• The Ministerial Ordinance on Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices
• The Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents
• Regulations for Buildings and Facilities of Pharmacies
• The Explanation of Application for Accreditation of Foreign Manufacturers
• Quality Management System Inspection of Medical Devices and In-Vitro Diagnostics in Japan

Buy Now!
Don’t be caught off-guard when inspectors from the PMDA show up at your facility. Japanese Medical Device Inspection Guide is just $297.