Regulatory Framework Overview
The Medical Device Division (MDD)
The Medical Device Division (MDD) of the Department of Health is the competent authority. It administers MDACS, publishes Technical References (TR series) and Guidance Notes (GN series), maintains the MDIS listing database, and coordinates vigilance.
MDACS — Administrative Control System
MDACS is modelled on GHTF/IMDRF principles and designed to ensure devices meet acceptable standards of safety, quality, and performance. Key features:
| Feature | Detail |
|---|---|
| Legal basis | Administrative (no current statute) |
| Technically voluntary | Yes — but de facto mandatory for market access |
| Reference-country reliance | Yes — expedited route for FDA, CE, TGA, Health Canada, MHRA, PMDA |
| Application fee | None charged by MDD |
| Listing database | MDIS (Medical Device Information System) |
| Local rep | LRP (Local Responsible Person) required for foreign manufacturers |
Toward Statutory Regulation
A proposed Medical Devices Ordinance would make listing mandatory by law. Until enacted, MDACS remains the operative framework. See Legislative Reform Outlook.