The fee structure closely reflects the fee prescribed in the Medical Device Regulation 2012 Schedule Fifth and hasn't changed per se.

No, the fees for single-role licenses (e.g., Manufacturer, AR, Distributor, or Importer alone) remain unchanged for both new and renewal applications.

The refund eligibility period for establishments affected by the new Single License policy will last from July 1, 2024, until the end of 2027.

To request a refund:

1. Complete the Google Form "Permohonan Pulangan Balik Hasil (Refund - Single License)" at https://forms.gle/fp5pDtL8Uu1h6Pau7

2. Provide all necessary information in the form

3. MDA will review the application history to determine eligibility

4. If approved, the MDA finance unit will refund the excess fees to the specified bank account

License fees have been adjusted to reflect the new policy. For example: - Single role licenses remain the same for both new and renewal applications - Combined roles now require separate applications/fees: - AR + Distributor: New license fee increased from RM 4000 to RM 6000 (RM 4000 + RM 2000) - AR + Importer + Distributor: New license fee increased from RM 4000 to RM 8000 (RM 4000 + RM 2000 + RM 2000)