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
| No. | Establishment License Number(s) | 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-3217-D122 | SYMBION HEALTHCARE SDN BHD | DISTRIBUTOR | SUSPENDED | 15 February 2024 |
| 5 | MDA-2952-K121 | U CARE PROTECTION INDUSTRIES SDN BHD | MANUFACTURER | SUSPENDED | 30 May 2024 |
| 6 | MDA-6756-W124 MDA-6665-D124 MDA-6704-P124 |
Touch Health Ventures | AUTHORISED REPRESENTATIVE DISTRIBUTOR IMPORTER |
SUSPENDED | 3 June 2025 |
CANCELLED ESTABLISHMENT LICENCES
| No. | Establishment Licence Number | Establishment Name | Licence Type | Status |
|---|---|---|---|---|
| 1 | KP99184171617 | Artisan Hartamas Sdn. Bhd. | Manufacturer | Cancelled |
| 2 | MDA-996-WDP57751 MDA-996-K6166 |
Serve Medical Technology Sdn. Bhd. | Authorised Representative, Distributor, Importer Manufacturer |
Cancelled |
| 3 | MDA-3979-W122 MDA-2844-D121 |
KBS Healthcare Marketing | Authorised Representative Distributor |
Cancelled |
| 4 | MDA-2226-W121 | Universal Therapeutics Sdn. Bhd. | Authorised Representative | Cancelled |
| 5 | MDA-3842-WDP122 | Solaris Scientific | Authorised Representative, Importer, Distributor | Cancelled |
| 6 | MDA-1278-W120 MDA-1101-D120 |
Veritas Medical Sdn. Bhd. | Authorised Representative Distributor |
Cancelled |
| 7 | MDA-4932-WDP123 | Kawayii Marketing Sdn. Bhd. | Authorised Representative, Distributor, Importer | Cancelled |
| 8 | MDA-2954-K121 | Arrowgate Sdn. Bhd. | Manufacturer | Cancelled |
| 9 | MDA-3217-D122 | Symbion Healthcare Sdn. Bhd. | Distributor | Cancelled |
| 10 | MDA-3512-WDP122 | ATN Medic Sdn. Bhd. | Authorised Representative, Importer, Distributor | Cancelled |
| 11 | MDA-4093-K122 MDA-5561-W124 |
Solaris Scientific (M) Sdn. Bhd. | Manufacturer Authorised Representative |
Cancelled |
CANCELLED MEDICAL DEVICE REGISTRATION CERTIFICATES
| No. | Certificate No. | Establishment Name | Manufacturer | Medical Device Name | Status |
|---|---|---|---|---|---|
| 1 | GD3877319-29693 | Medimec Resources | SMB Corporation of India | SMB Copper T Intrauterine Contraceptive Device (IUCD Cu375, IUCD Cu250) | Cancelled |
| 2 | GA8867220-44985 | ADL Medical System Sdn. Bhd. | Quanzhou Baizhong United Technology Co., Ltd. | Disposable Nursing Masks | Cancelled |
| 3 | GMD31569325017A | Shriro (Malaysia) Sdn. Bhd. | Halyard Health, Inc | Specialty Face Masks | Cancelled |
| 4 | GMD87321938218A | Medind Sdn. Bhd. | One Top Protective Co., Ltd | Surgical Facemask | Cancelled |
| 5 | GMD28694832718A | Cranberry (M) Sdn. Bhd. | Cranberry (M) Sdn. Bhd. | Cranberry Face Mask | Cancelled |
| 6 | GA9284019-36560 | Felco Lifescience Sdn. Bhd. | Yangzhou Super Union Import & Export Co., Ltd. | Surgical Face Mask | Cancelled |
| 7 | GA5835919-29925 | [Same as Establishment] | Jiaxing U-Life Medical Device Technology Co., Ltd. | Face Mask Surgical | Cancelled |
| 8 | GA3339620-45216 | Medipro (Malaysia) Sdn. Bhd. | Medipro (Malaysia) Sdn. Bhd. | Surgical Mask | Cancelled |
| 9 | GA49624538318 | Meditex Industries Sdn. Bhd. | Meditex Industries Sdn. Bhd. | Surgical Face Mask | Cancelled |
| 10 | GA7951920-41596 | [Same as Establishment] | Anqing Kangmingna Packaging Co., Ltd | Disposable Face Mask | Cancelled |
| 11 | GMD12130540418A | Omnicare Industries Sdn. Bhd. | Omnicare Industries Sdn. Bhd. | Disposable Face Mask | Cancelled |
| 12 | GMD48359548718A | Pro Life Medical Supplies Sdn. Bhd. | Zhejiang Medicines & Health Products I/E Co., Ltd. | Surgical Face Mask | Cancelled |
| 13 | GD3877319-29693 | Medimec Resources | SMB Corporation of India | SMB Copper T Intrauterine Contraceptive Device (IUCD Cu375, IUCD Cu250) | Cancelled |
| 14 | GB5838623-145134 | Solaris Scientific | Solaris Scientific (M) Sdn. Bhd. | Yiana PRP Kit | Cancelled |
| 15 | GD7590922-112081 | Solaris Scientific | The Wave Innovation Group SRLS | Viscos Intra Articular Hyaluronic Acid | Cancelled |
Last updated: 3 June 2025
Uploaded by: Corporate Communication Unit
This list will be updated periodically and may be revised from time to time.
