February 16, 2024, marks the date from which MDA established that new license applications could only be filed for one role per application. This was an initial step in transitioning to the full implementation of the Single License policy on July 1, 2024.

Key dates are:
- February 16, 2024: New license applications
limited to one role per application
- July 1, 2024: Full implementation begins; renewal
applications for licenses with multiple roles no longer
allowed
- July 1, 2024 to end of 2027: Period for affected
establishments to apply for refunds of excess fees
paid

The new policy, directed by the Minister of Health's General Order No. 1 of 2024, mandates that each establishment role requires a separate license. This policy will come into effect on July 1, 2024.

Manufacturers with a Manufacturer License can engage in manufacturing medical devices and distributing only the devices they manufacture. Their license fee remains unchanged at RM 4000 for new applications and RM 2000 for renewals.

The permitted activities are: - Manufacturer License: Manufacturing and distribution of medical devices (only for devices manufactured by them) - Authorized Representative (AR) License: Registering medical devices - Authorized Importer License: Importing registered medical devices - Distributor License: Distributing registered medical devices

The permitted activities are:
- Manufacturer License: Manufacturing and
distribution of medical devices (only for devices
manufactured by them)
- Authorized Representative (AR) License:
Registering medical devices
- Authorized Importer License: Importing registered
medical devices
- Distributor License: Distributing registered medical
devices

After July 1, 2024, establishments that previously held a single license as an AR while also conducting importing and distribution activities will need to obtain separate licenses for importing and distribution if they intend to continue these activities.

Starting July 1, 2024, establishments with licenses that currently combine multiple roles will no longer be allowed to renew these combined licenses. Instead, they will need to apply for separate licenses for each role they wish to maintain.

For new license applications filed from February 16, 2024, establishments can only choose one role per application. They are no longer allowed to combine multiple roles in a single new license application.

They should: 1. File a renewal application for the existing license, keeping only one role 2. Update the Google Form to indicate the Submission ID and the role being maintained 3. Apply for new licenses for the additional roles that were previously combined 4. Update the Google Form again to indicate the Submission IDs for the new license applications 5. Complete the Refund Request Form for fee refunds

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)

The single authorization, the single license policy will be fully implemented starting from July 1, 2024, and it will continue until the end of 2027 (until all of the establishments have converted their multiple-role licenses into single-role licenses).

They will have to separate the license that corresponds to the activities that they intend to conduct during renewal (Authorized representative, importer, distributor).

Establishments can forward their inquiries regarding the single license policy to the License Unit official email address: license-unit@mda.gov.my

Appendix 3 provides a comparison of license fees before and after the implementation of the Single License policy. It shows how fees have changed for various combinations of roles.

Appendix 2 outlines the procedure for license applications for establishments that want to renew licenses with grouped roles starting July 1, 2024.

Appendix 1 provides scenarios to help establishments understand the implementation of the Single License policy. It covers new license applications, license renewal applications before July 1, 2024, and permitted activities after that date.

Two Google Forms are mentioned: "Borang Kemaskini Peranan Establismen" (for updating establishment role information) and "Permohonan Pulangan Balik Hasil (Refund - Single License)" (for requesting refunds).

After July 1, 2024, ARs who also import and distribute must obtain separate licenses for each of these activities if they wish to continue them.

MDA will review the application history to determine refund eligibility, based on information provided in the forms and the establishment's system records.

MDA will evaluate the application, request additional documents if needed, and approve the application once it's complete. Fees must be paid according to the Medical Device Regulations 2012. Refund eligibility will also be assessed.

The policy is based on the Minister of Health's General Order No. 1 of 2024, directing the implementation of the single license policy for each establishment role.

A new application can be submitted after the renewal application process is completed or concurrently with the renewal application if the role has been updated in the Medcast system.

The process of removing roles will take 3-5 working days after the role update form is submitted.