2014 PMD Act Amendments — Overview
The 2014 amendments — which took effect in November 2014 — are the most significant restructuring of Japan's medical product legislation in decades. They renamed the law, created dedicated frameworks for medical devices and regenerative medicine, and introduced the three-pathway pre-market system (Shonin/Ninsho/Todokede) in its modern form.
The rename: from PAL to PMD Act
Before 2014, the legislation was the Pharmaceutical Affairs Law (PAL / 薬事法). The 2014 amendments renamed it the Pharmaceuticals and Medical Devices Act (PMD Act / 薬機法), reflecting the expanded scope to explicitly cover medical devices and regenerative medicine products as distinct categories rather than subsets of pharmaceuticals.
Introduction of the three-pathway system
The 2014 amendments formalised the Ninsho (certification) pathway as a distinct pre-market route for Class II devices with applicable recognised standards. Before 2014, certification by RCBs existed but in a less structured form. Post-2014:
- Shonin (approval by MHLW following PMDA review) — Class III/IV and Class II without standard
- Ninsho (certification by RCB) — Class II with recognised standard; some Class III
- Todokede (notification to prefectural government) — Class I
This three-pathway structure is still the operative framework today.
Regenerative medicine products — separate category
The 2014 amendments created a new regulatory category for regenerative medicine products (再生医療等製品) — cellular and gene therapy products. This separated these products from both the pharmaceutical and medical device categories and gave them their own conditional and time-limited approval system.
Programme Medical Devices — first statutory recognition
The 2014 amendments provided the first explicit statutory basis for regulating software as a medical device (Programme Medical Devices / プログラム医療機器). MHLW subsequently issued notifications elaborating on the framework.
MAH and QMS framework strengthened
The 2014 amendments strengthened the MAH concept and explicitly required the MAH to oversee the quality management of contracted manufacturers — the origin of the MAH quality oversight requirements now in MO 169.
Risk-based classification reforms
The four-class system (I–IV) was refined and the Cabinet Order categorisations updated to improve risk-proportionality of the pre-market requirements.