Description
Expanding into the Japanese medical device market requires full compliance with the Pharmaceutical and Medical Device Act (PMD Act) and strict regulatory oversight by the Pharmaceuticals and Medical Devices Agency (PMDA). Obtaining medical device marketing authorization in Japan is a multi-step process, including proper classification, regulatory pathway selection, and compliance with Japanese Good Manufacturing Practice (JGMP) and Quality Management System (QMS) Ordinance (MHLW Ordinance No. 169/2004).
SOP-REG-002: Medical Device Marketing Authorization in Japan provides a structured, step-by-step framework to ensure a fast, compliant, and efficient approval process for manufacturers, importers, and Market Authorization Holders (MAHs). This SOP aligns with the Medical Device Single Audit Program (MDSAP), allowing companies to leverage their existing ISO 13485 or MDSAP certification for a smoother approval process. Whether you are submitting a Pre-Market Submission (Todokede), Pre-Market Certification (Ninsho), or Pre-Market Approval (Shonin), this SOP is designed to simplify regulatory compliance and ensure faster access to the Japanese market.
Why You Need This SOP
Japan has one of the strictest regulatory environments for medical devices, with a complex approval system that requires adherence to PMDA, MHLW, and JGMP standards. Failure to meet these requirements can lead to delays, rejected applications, and loss of market access. This SOP provides a structured, easy-to-follow guide that helps you:
🔹 Navigate PMDA regulations efficiently and determine the correct submission pathway.
🔹 Accelerate the registration process while avoiding unnecessary delays.
🔹 Ensure full compliance with Japanese QMS requirements, reducing regulatory risk.
🔹 Leverage MDSAP certification for streamlined JGMP audits.
🔹 Standardize your regulatory documentation, ensuring completeness for approval.
🔹 Meet post-market obligations, including product surveillance and vigilance reporting.
Who Should Buy This SOP?
This SOP is an essential tool for companies looking to enter or expand in the Japanese medical device market. It is ideal for:
✔ Medical Device Manufacturers seeking PMDA approval.
✔ Regulatory Affairs Professionals managing medical device submissions.
✔ Importers & Market Authorization Holders (MAH) responsible for device registration.
✔ Consultants and Advisors supporting regulatory approvals in Japan.
✔ Startups & SMEs needing a cost-effective and structured approach to compliance.
Why Choose This SOP?
SOP-REG-002: Medical Device Marketing Authorization in Japan is fully compliant with PMDA and MHLW requirements and integrates MDSAP best practices to ensure a smooth approval process. This SOP will help you:
✔ Save time and eliminate uncertainty by following a proven methodology.
✔ Prevent application rejections by ensuring regulatory completeness.
✔ Ensure compliance with Japan’s strict QMS and GMP requirements.
✔ Reduce costs by avoiding unnecessary resubmissions and regulatory fines.
✔ Gain market access faster by ensuring a seamless approval process.
