Status
List of Registered Conformity Assessment Body (CAB)
Section 10 (1) Medical Device Act 2012 (Act 737) & Regulation 8, Medical Device Regulation 2012
|
REGISTRATION NO. |
NAME OF CONFORMITY ASSESSMENT BODY |
EXPIRY DATE |
CAB DETAILS |
PERSONNEL DETAILS |
|
MDA/CAB-001 |
TUV SUD (MALAYSIA) SDN. BHD. |
20/11/2025 |
||
|
MDA/CAB-002 |
MEDCERT MALAYSIA SDN. BHD. |
20/11/2025 |
||
|
MDA/CAB-003 |
SGS MALAYSIA SDN. BHD. |
20/11/2025 |
||
|
MDA/CAB-004 |
SIRIM QAS INTERNATIONAL SDN. BHD. |
20/11/2025 |
||
|
MDA/CAB-005 |
BSI SERVICES MALAYSIA SDN. BHD. |
20/11/2025 |
||
|
MDA/CAB-006 |
DQS CERTIFICATION (M) SDN. BHD. |
11/09/2023 |
||
|
MDA/CAB-007 |
TUV RHEINLAND MALAYSIA (M) SDN. BHD. |
11/09/2023 |
||
|
MDA/CAB-008 |
TUV NORD (M) SDN. BHD. |
11/09/2023 |
||
|
MDA/CAB-009 |
CARE CERTIFICATION INTERNATIONAL (M) SDN. BHD. |
11/02/2024 |
||
|
MDA/CAB-012 |
CI INTERNATIONAL CERTIFICATION SDN. BHD. |
24/06/2024 |
||
|
MDA/CAB-013 |
KGS CERTIFICATION SDN. BHD. |
11/11/2024 |
||
|
MDA/CAB-014 |
DNV GL INTERNATIONAL SDN. BHD. |
17/05/2025 |
||
|
MDA/CAB-016 |
GENUINE DIAMOND SDN. BHD. |
21/11/2024 |
||
|
MDA/CAB-017 |
ITC ZENITH (M) SDN. BHD. |
13/04/2023 |
||
|
MDA/CAB-018 |
NEWERA INTERNATIONAL CERTIFICATION SDN. BHD. |
17/12/2023 |
||
|
MDA/CAB-019 |
ASI CERTIFICATION SDN. BHD. |
11/11/2024 |
||
|
MDA/CAB-020 |
MEDIVICE CERTIFICATION SDN. BHD. |
03/04/2025 |
||
|
MDA/CAB-021 |
KIWA INTERNATIONAL CERTIFICATIONS (M) SDN. BHD. |
03/04/2025 |
||
| MDA/CAB-022 | AQC TECHNICAL ASSESSORS (M) SDN BHD | 16/06/2024 | ↓ | |
| MDA/CAB-023 | NIOSH CERTIFICATION SDN. BHD | 28/08/2025 | ↓ |
Note : Please click (↓) to view the CAB AND PERSONNEL DETAILS.
List of Registered Medical Device Technical Areas
|
No |
Personnel |
Total |
|
1. |
Registered MD 0101 Technical Personnel |
24 |
|
2. |
Registered MD 0102 Technical Personnel |
27 |
|
3. |
Registered MD 0103 Technical Personnel |
13 |
|
4. |
Registered MD 0104 Technical Personnel |
20 |
|
5. |
Registered MD 0105 Technical Personnel |
9 |
|
6. |
Registered MD 0106 Technical Personnel |
35 |
|
7. |
Registered MD 0107 Technical Personnel |
22 |
|
8. |
Registered MD 0108 Technical Personnel |
21 |
|
9. |
Registered MD 0109 Technical Personnel |
4 |
|
10. |
Registered MD 0201 Technical Personnel |
5 |
|
11. |
Registered MD 0202 Technical Personnel |
13 |
|
12. |
Registered MD 0203 Technical Personnel |
7 |
|
13. |
Registered MD 0204 Technical Personnel |
7 |
|
14. |
Registered MD 0301 Technical Personnel |
20 |
|
15. |
Registered MD 0302 Technical Personnel |
7 |
|
16. |
Registered MD 0303 Technical Personnel |
13 |
|
17. |
Registered MD 0401 Technical Personnel |
11 |
|
18. |
Registered MD 0402 Technical Personnel |
10 |
|
19. |
Registered MD 0403 Technical Personnel |
10 |
|
20. |
Registered MD 1101 Technical Personnel |
9 |
|
21. |
Registered MD 1102 Technical Personnel |
4 |
|
22. |
Registered MD 1103 Technical Personnel |
4 |
|
23. |
Registered MD 1104 Technical Personnel |
5 |
|
24. |
Registered MD 1105 Technical Personnel |
1 |
|
25. |
Registered MD 1106 Technical Personnel |
4 |
|
26. |
Registered MD 1107 Technical Personnel |
3 |
|
27. |
Registered MD 1108 Technical Personnel |
4 |
|
28. |
Registered MD 1109 Technical Personnel |
4 |
|
29. |
Registered MD 1110 Technical Personnel |
2 |
|
30. |
Registered MD 1111 Technical Personnel |
5 |
|
31. |
Registered MD 1201 Technical Personnel |
3 |
|
32. |
Registered MD 1202 Technical Personnel |
5 |
|
33. |
Registered MD 1301 Technical Personnel |
8 |
|
34. |
Registered MD 1302 Technical Personnel |
6 |
|
35. |
Registered MD 1401 Technical Personnel |
0 |
|
36. |
Registered MD 1402 Technical Personnel |
4 |
|
37. |
Registered MD 1403 Technical Personnel |
2 |
|
38. |
Registered MD 1404 Technical Personnel |
1 |
|
39. |
Registered AIMD 0101 Technical Personnel |
1 |
|
40. |
Registered AIMD 0102 Technical Personnel |
1 |
|
41. |
Registered AIMD 0103 Technical Personnel |
0 |
|
42. |
Registered IVD 0101 Technical Personnel |
3 |
|
43. |
Registered IVD 0102 Technical Personnel |
2 |
|
44. |
Registered IVD 0103 Technical Personnel |
2 |
|
45. |
Registered IVD 0201 Technical Personnel |
5 |
|
46. |
Registered IVD 0202 Technical Personnel |
4 |
|
47. |
Registered IVD 0203 Technical Personnel |
6 |
|
48. |
Registered IVD 0301 Technical Personnel |
0 |
|
49. |
Registered IVD 0302 Technical Personnel |
0 |
|
50. |
Registered IVD 0303 Technical Personnel |
3 |
|
51. |
Registered IVD 0304 Technical Personnel |
1 |
|
52. |
Registered IVD 0305 Technical Personnel |
4 |
|
53. |
Registered IVD 0306 Technical Personnel |
2 |
|
54. |
Registered IVD 0307 Technical Personnel |
4 |
|
55. |
Registered IVD 0308 Technical Personnel |
1 |
|
56. |
Registered IVD 0309 Technical Personnel |
5 |
|
57. |
Registered IVD 0401 Technical Personnel |
6 |
|
58. |
Registered IVD 0402 Technical Personnel |
1 |
|
59. |
Registered IVD 0403 Technical Personnel |
7 |
|
60. |
Registered IVD 0404 Technical Personnel |
7 |
|
61. |
Registered IVD 0405 Technical Personnel |
5 |
|
62. |
Registered IVD 0406 Technical Personnel |
10 |
|
63. |
Registered MDS 7001 Technical Personnel |
1 |
|
64. |
Registered MDS 7002 Technical Personnel |
2 |
|
65. |
Registered MDS 7003 Technical Personnel |
0 |
|
66. |
Registered MDS 7004 Technical Personnel |
2 |
|
67. |
Registered MDS 7005 Technical Personnel |
8 |
|
68. |
Registered MDS 7206 Technical Personnel |
3 |
|
69. |
Registered MDS 7207 Technical Personnel |
1 |
|
70. |
Registered MDS 7208 Technical Personnel |
0 |
|
71. |
Registered MDS 7209 Technical Personnel |
1 |
|
72. |
Registered MDS 7210 Technical Personnel |
3 |
For detail of each scope expression, please click HERE!
CAB Registration
If you need further assistance or have any queries regarding Conformity Assessment Body (CAB), please do not hesitate to contact our officers from the CAB Registration Unit:
(1) PN. WAN HUSNIATI BINTI WAN ABDULLAH at 03-8230 0398 ()
(2) EN. MOHD FADHULLAH BIN ABD HALIM at 03-8230 0356 ()
Contact
For more enquiries, please contact us:
CAB Registration Unit
PIHAK BERKUASA PERANTI PERUBATAN
Medical Device Authority
KEMENTERIAN KESIHATAN MALAYSIA
Ministry of Health Malaysia
Aras 5 & 6, Prima 9, Prima Avenue II,
Blok 3547, Persiaran APEC,
63000 Cyberjaya, Selangor
Tel :+603 8230 0350/ 0398/ 0356
Faks : +603 8230 0200
Email :
Updated: 21st February 2023
