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 NumberEstablishment NameLicense TypeStatusSuspension 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
7 MDA-4307-D123 Orthomax Surgical Supply Sdn. Bhd. Distributor Suspended 22 September 2025
8 MDA-4307-D124 Kimula Sdn. Bhd. Manufacturer Suspended 25 September 2025

 


REVOKED ESTABLISHMENT LICENCES

No.Establishment Licence NumberEstablishment NameLicence TypeStatus
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.Certificate No.Establishment NameManufacturerMedical Device NameStatus
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: 30 September 2025

Prepared by: Licensing Unit

Uploaded by: Corporate Communication Division

 

This list will be updated periodically and may be revised from time to time.