Key Timelines & Fees
Fee Updates
Fees are indicative. Always verify current fee schedules on the MyMDA portal before submission.
Establishment Licensing Fees
| Licence Type | Application Fee (MYR) | Annual Fee (MYR) |
|---|---|---|
| Manufacturer | RM 2,000 | RM 1,000 |
| Importer | RM 1,500 | RM 750 |
| Distributor | RM 1,000 | RM 500 |
| Authorised Representative | RM 1,500 | RM 750 |
Establishment licences are valid for 1 year and must be renewed annually.
Device Registration Fees
| Device Class | Registration Fee (MYR) | Renewal Fee (MYR) |
|---|---|---|
| Class A | RM 500 | RM 200 |
| Class B | RM 1,500 | RM 500 |
| Class C | RM 3,000 | RM 1,000 |
| Class D | RM 5,000 | RM 2,000 |
Registration is valid for 5 years from the date of approval.
Processing Timelines
| Application Type | Target Timeline |
|---|---|
| Class A notification | 30 working days |
| Class B registration | 90 working days |
| Class C registration | 120 working days |
| Class D registration | 180 working days |
| Establishment licence (new) | 30 working days |
| Establishment licence renewal | 14 working days |
| Variation (minor) | 30 working days |
| Variation (major) | 90 working days |
| Registration renewal | 60 working days |
Clock Stops
The review clock stops when MDA issues a query (Deficiency Letter). The applicant typically has 60 days to respond.
Variation Fees
| Variation Type | Fee (MYR) |
|---|---|
| Administrative change | RM 100 |
| Minor technical change | RM 300 |
| Major technical change | RM 1,000 |
Tips to Avoid Delays
- Ensure submission completeness before submitting
- Follow MDA checklists for each device class
- Request a pre-submission meeting for novel/complex devices
- Respond to queries within 30 days (not the full 60) to keep reviews moving
- Track application status via MyMDA