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-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

 

 

LIST OF CANCELLED MEDICAL DEVICE REGISTRATION CERTIFICATES

BIL

MEDICAL DEVICE REGISTRATION CERTIFICATE NUMBER

ESTABLISMENT 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. YANGZHOU SUPER UNION IMPORT & EXPORT CO., LTD. CANCELLED
7 GA5835919-29925 GA5835919-29925 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 GA7951920-41596 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: 14 /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.