SUSPENDED/REVOKED ESTABLISHMENT LICENCES AND CANCELLED MEDICAL DEVICES
All establishments placing medical devices in the market must possess an Establishment Licence, and the medical devices must be registered as stipulated under the Medical Device Act 2012 (Act 737).
The public may verify the status of Establishment Licences and medical device registrations through the search function available at: https://mdar.mda.gov.my/
However, certain establishments have violated the provisions under Act 737 and the Medical Device Regulations 2012. As a result, the Medical Device Authority (MDA) has taken enforcement actions by suspending or cancelling the Establishment Licences and Medical Device Registration Certificates.
The following are the details of the suspended and cancelled licences and certificates:
SUSPENDED ESTABLISHMENT LICENCES
| O. | ESTABLISHMENT LICENSE NUMBER | ESTABLISHMENT NAME | LICENSE TYPE | STATUS | SUSPENSION DATE |
|---|---|---|---|---|---|
| 1 | MDA-2545-W121 MDA-2277-D121 |
CARPET PRIMA SDN. BHD. | AUTHORISED REPRESENTATIVE DISTRIBUTOR |
SUSPENDED | 25 February 2022 |
| 2 | MDA-1497-K120 | DIROSYS SOLUTIONS (M) SDN. BHD. | MANUFACTURER | SUSPENDED | 9 May 2023 |
| 3 | MDA-2447-K121 | EVA ENERGY SDN. BHD. | MANUFACTURER | SUSPENDED | 14 June 2023 |
| 4 | MDA-2952-K121 | U CARE PROTECTION INDUSTRIES SDN. BHD. | MANUFACTURER | SUSPENDED | 30 May 2024 |
| 5 | MDA-6756-W124 MDA-6665-D124 MDA-6704-P124 |
TOUCH HEALTH VENTURES | AUTHORISED REPRESENTATIVE DISTRIBUTOR IMPORTER |
SUSPENDED | 3 June 2025 |
| 6 | MDA-4307-D123 | ORTHOMAX SURGICAL SUPPLY SDN. BHD. | DISTRIBUTOR | SUSPENDED | 22 September 2025 |
| 7 | MDA-4307-D124 | KIMULA SDN. BHD. | MANUFACTURER | SUSPENDED | 25 September 2025 |
REVOKED ESTABLISHMENT LICENCES
| No. | Establishment Licence Number | Establishment Name | Licence Type | Status |
|---|---|---|---|---|
| 1 | KP99184171617 | Artisan Hartamas Sdn. Bhd. | Manufacturer | Revoked |
| 2 | MDA-996-WDP57751 MDA-996-K6166 |
Serve Medical Technology Sdn. Bhd. | Authorised Representative, Distributor, Importer Manufacturer |
Revoked |
| 3 | MDA-3979-W122 MDA-2844-D121 |
KBS Healthcare Marketing | Authorised Representative Distributor |
Revoked |
| 4 | MDA-2226-W121 | Universal Therapeutics Sdn. Bhd. | Authorised Representative | Revoked |
| 5 | MDA-3842-WDP122 | Solaris Scientific | Authorised Representative, Importer, Distributor | Revoked |
| 6 | MDA-1278-W120 MDA-1101-D120 |
Veritas Medical Sdn. Bhd. | Authorised Representative Distributor |
Revoked |
| 7 | MDA-4932-WDP123 | Kawayii Marketing Sdn. Bhd. | Authorised Representative, Distributor, Importer | Revoked |
| 8 | MDA-2954-K121 | Arrowgate Sdn. Bhd. | Manufacturer | Revoked |
| 9 | MDA-3217-D122 | Symbion Healthcare Sdn. Bhd. | Distributor | Revoked |
| 10 | MDA-3512-WDP122 | ATN Medic Sdn. Bhd. | Authorised Representative, Importer, Distributor | Revoked |
| 11 | MDA-4093-K122 MDA-5561-W124 |
Solaris Scientific (M) Sdn. Bhd. | Manufacturer Authorised Representative |
Revoked |
CANCELLED MEDICAL DEVICE REGISTRATION CERTIFICATES
|
No. |
Establishment Licence Number |
Establishment Name |
Type of Licence |
Status |
Date of Cancellation |
|
1 |
KP99184171617 |
ARTISAN HARTAMAS SDN BHD |
Manufacturer |
Cancelled |
- |
|
2 |
MDA-996-WDP57751 |
SERVE MEDICAL TECHNOLOGY SDN BHD |
Authorised Representative, Distributor, Importer |
Cancelled |
04/05/2021 |
|
3 |
MDA-996-K6166 |
SERVE MEDICAL TECHNOLOGY SDN BHD |
Manufacturer |
Cancelled |
04/05/2021 |
|
4 |
MDA-3979-W122 |
KBS HEALTHCARE MARKETING |
Authorised Representative, Distributor |
Cancelled |
27/02/2023 |
|
5 |
MDA-2226-W121 |
UNIVERSAL THERAPEUTICS SDN BHD |
Authorised Representative |
Cancelled |
27/02/2023 |
|
6 |
MDA-3842-WDP122 |
SOLARIS SCIENTIFIC |
Authorised Representative, Importer, Distributor |
Cancelled |
31/10/2023 |
|
7 |
MDA-1278-W120 |
VERITAS MEDICAL SDN BHD |
Authorised Representative, Distributor |
Cancelled |
19/01/2024 |
|
8 |
MDA-4932-WDP123 |
Kawayii Marketing Sdn Bhd |
Authorised Representative, Distributor, Importer |
Cancelled |
21/03/2024 |
|
9 |
MDA-2954-K121 |
Arrowgate Sdn Bhd |
Manufacturer |
Cancelled |
29/07/2024 |
|
10 |
MDA-3217-D122 |
Symbion Healthcare Sdn Bhd |
Distributor |
Cancelled |
06/11/2024 |
|
11 |
MDA-3512-WDP122 |
ATN Medic Sdn Bhd |
Authorised Representative, Importer, Distributor |
Cancelled |
15/01/2025 |
|
12 |
MDA-4093-K122 |
Solaris Scientific (M) Sdn Bhd |
Manufacturer, Authorised Representative |
Cancelled |
05/05/2025 |
|
13 |
MDA-7100-W124 |
YG BUMI ENTERPRISE |
Authorised Representative, Importer, Distributor |
Cancelled |
10/11/2025 |
Last updated: 11 /11 / 2025
Prepared by: Licensing Unit
Uploaded by: Corporate Communication Division
This list will be updated periodically and may be revised from time to time.
