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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

DETAILS

MDA/CAB-001

TUV SUD (MALAYSIA) SDN. BHD.

20/11/2019

     

MDA/CAB-002

MEDCERT MALAYSIA SDN. BHD.

20/11/2019

     

MDA/CAB-003

SGS MALAYSIA SDN. BHD.

20/11/2019

     

MDA/CAB-004

SIRIM QAS INTERNATIONAL SDN. BHD.

20/11/2019

     

MDA/CAB-005

BSI SERVICES MALAYSIA SDN. BHD.

20/11/2019

     

MDA/CAB-006

DQS CERTIFICATION (M) SDN. BHD.

11/09/2020

     

MDA/CAB-007

TUV RHEINLAND MALAYSIA (M) SDN. BHD.

11/09/2020

     

MDA/CAB-008

TUV NORD (M) SDN. BHD.

11/09/2020

     

MDA/CAB-009

CARE CERTIFICATION INTERNATIONAL (M) SDN. BHD.

11/02/2021

     

MDA/CAB-012

CI INTERNATIONAL CERTIFICATION SDN. BHD.

09/04/2021

     

MDA/CAB-013

KGS CERTIFICATION SDN. BHD.

26/09/2021

     

MDA/CAB-014

DNV GL MALAYSIA SDN. BHD.

26/09/2021

     

MDA/CAB-015

PLATINUM SHAUFFMANTZ VERITAS SDN. BHD.

26/02/2022

     

MDA/CAB-016

GENUINE DIAMOND SDN. BHD.

21/11/2021

     

MDA/CAB-017

ITC ZENITH (M) SDN. BHD.

13/04/2020

     

MDA/CAB-018

NEWERA INTERNATIONAL CERTIFICATION SDN. BHD.

17/12/2020

     

MDA/CAB-019

ASI CERTIFICATION SDN. BHD.

07/11/2021

     

MDA/CAB-020

MEDIVICE CERTIFICATION SDN. BHD.

03/04/2022

     

MDA/CAB-021

KIWA INTERNATIONAL CERTIFICATIONS (M) SDN. BHD.

03/04/2022

     

Note : Please click  (↓) to download the CAB 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 (whusniati@mda.gov.my)

(2) EN. MOHD FADHULLAH BIN ABD HALIM at 03-8230 0356 (fadhullah@mda.gov.my)

 

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/ 0352/ 0356                                                               
Faks : +603 8230 0200
Email   : cabregistration @ mda.gov.my   

Print

  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my