Description
Compliance with Japan’s medical device vigilance regulations is essential for ensuring patient safety and maintaining regulatory approval. The Pharmaceutical and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW) enforce strict post-market surveillance (PMS) and adverse event reporting requirementsunder the Pharmaceutical and Medical Device Act (PMD Act) and the Good Vigilance Practice (GVP) Ordinance (MHLW Ordinance No. 135/2004).
SOP-REG-006: Medical Device Vigilance Reporting in Japan provides a structured, step-by-step framework to help manufacturers, importers, and Marketing Authorization Holders (MAHs) meet their regulatory obligations. This SOP ensures compliance with MHLW adverse event reporting requirements, including serious incident reporting, trend analysis, and risk management procedures. It is aligned with ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP) to facilitate seamless compliance with Japanese post-market surveillance laws.
Ensuring compliance with Japan’s post-market surveillance (PMS) and vigilance reporting regulations is critical for maintaining market authorization and avoiding regulatory actions from PMDA and MHLW. Non-compliance can result in fines, product recalls, or suspension of market authorization, jeopardizing your company’s operations in Japan.
SOP-REG-006: Medical Device Vigilance Reporting in Japan provides a clear, structured approach to:
🔹 Identifying and assessing adverse events to determine their reportability under Japanese law.
🔹 Complying with MHLW’s Good Vigilance Practice (GVP) requirements for post-market monitoring.
🔹 Ensuring accurate and timely reporting of medical device malfunctions, serious injuries, and deaths to PMDA.
🔹 Implementing effective risk management strategies to prevent further incidents.
🔹 Maintaining compliance with MDSAP and ISO 13485:2016 for international regulatory alignment.
This SOP is essential for Medical Device Manufacturers, Regulatory Affairs Professionals, Importers, MAHs, Consultants, and Startups who need a cost-effective and structured approach to medical device vigilance reporting in Japan.
With SOP-REG-006, your business can streamline post-market compliance, avoid regulatory penalties, and enhance patient safety while maintaining a strong regulatory presence in Japan.
