Regulatory Roadmap

The Five-Stage Pathway

Stage	Activity	Key Output
1 — Determine Scope	Is product a medical device under Act 737?	In/out decision
2 — Classify Device	Apply classification rules → Class A, B, C, or D	Device class
3 — Establishment Licence	Manufacturer / importer / distributor / LAR licence via MyMDA	Valid licence
4 — Register Device	Submit registration dossier via MyMDA → MDA review → DRN	Device Registration Number
5 — Maintain Compliance	PMS, MPR, FSCA, change notification, renewal	Ongoing registration

Stage 1 — Determine Scope

→ Review the definition under Section 2, Act 737
→ See What is a Medical Device? and Is Your Product a Medical Device?

Stage 2 — Classify the Device

→ Apply rules in the Medical Device Regulations 2012 Schedule
→ Assign Class A, B, C, or D — this determines dossier depth and fees
→ See Classification Overview

Stage 3 — Obtain Establishment Licence

→ All manufacturers, importers, and distributors must hold a licence
→ Foreign manufacturers appoint a LAR who holds the licence
→ Apply via MyMDA portal — valid 1 year, renewed annually
→ See Establishment Licensing

Stage 4 — Register the Device

Class	Route	Key Requirement
A	Notification	Self-declaration of conformity
B	Full registration	Technical file + QMS
C	Full registration	Enhanced technical file + clinical evidence
D	Full registration	Full design dossier + clinical data

→ MDA issues Device Registration Number (DRN) on approval — valid 5 years
→ See Device Registration

Stage 5 — Maintain Compliance

• PMS — systematic data collection on device performance
• MPR — report serious incidents to MDA
• FSCA — implement and notify field actions
• Change notification — seek approval for changes
• Renewal — before 5-year expiry

→ See Post-Market Requirements

Start with Classification

Device class determines fees, dossier depth, timelines, and conformity assessment route. Classify correctly before investing in dossier preparation.