Key Timelines & Fees
Fees are current as of the last update to this guidance. Always verify the most current fee schedules on the MyMDA portal (mymda.mda.gov.my) before submitting your application, as MDA may adjust fees without advance notice.
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 |
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
Payment Timing & Refunds
Establishment and device registration fees are payable upon application submission via the MyMDA portal. Fees are non-refundable if an application is rejected or withdrawn after submission. Variation fees are due when the variation application is submitted.