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  • ITC Rev07-2018 PDF

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    Dhyra Osem Science
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    This document is a scope of registration issued by the Medical Device Authority (MDA) of Malaysia to ITC Zenith (M) Sdn. Bhd. It lists 47 different scopes that ITC Zenith is registered to provide conformity assessment services for, including quality management systems like ISO 13485 and technical areas for medical device types from various categories like implants, wound care products, imaging devices, and in vitro diagnostic devices. The document also lists conformity assessment by way of verification as an additional scope. The registration is signed off by the MDA and provides contact information for ITC Zenith.

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    [17] ITC Rev07-2018.pdf

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    This document is a scope of registration issued by the Medical Device Authority (MDA) of Malaysia to ITC Zenith (M) Sdn. Bhd. It lists 47 different scopes that ITC Zenith is registered to provide conformity assessment services for, including quality management systems like ISO 13485 and technical areas for medical device types from various categories like implants, wound care products, imaging devices, and in vitro diagnostic devices. The document also lists conformity assessment by way of verification as an additional scope. The registration is signed off by the MDA and provides contact information for ITC Zenith.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    50 views2 pages

    ITC Rev07-2018 PDF

    Uploaded by

    Dhyra Osem Science
    This document is a scope of registration issued by the Medical Device Authority (MDA) of Malaysia to ITC Zenith (M) Sdn. Bhd. It lists 47 different scopes that ITC Zenith is registered to provide conformity assessment services for, including quality management systems like ISO 13485 and technical areas for medical device types from various categories like implants, wound care products, imaging devices, and in vitro diagnostic devices. The document also lists conformity assessment by way of verification as an additional scope. The registration is signed off by the MDA and provides contact information for ITC Zenith.

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    © All Rights Reserved
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    of 2

    Reference Number: (52) MDA.

    600-1//1/18 JILID 2
    Revision Date: JULY 2, 2018

    MEDICAL DEVICE AUTHORITY (MDA)


    MINISTRY OF HEALTH MALAYSIA (MOH)

    ITC ZENITH (M) SDN. BHD. Person Responsible:


    NO. 37 JALAN BULAN U5/BL MR. MANOGARAN A/L VAJURAM
    BANDAR PINGGIRAN SUBANG [itczenith.msia@gmail.com]
    SEKSYEN U5
    40150 SHAH ALAM Contact Person:
    SELANGOR DARUL EHSAN MR. NEELENDRAN A/L MACHAPUVALIAH
    Tel. No.: +603-7832 4224 MS. GOMATHI A/P RAJENDRAN
    Fax. No.: +603-7842 2678 [itczenith.msia@gmail.com]

    SCOPE OF REGISTRATION
    No. Scope Scope Expression
    Conformity Assessment of Quality Management System (QMS)
    (1) ISO 13485 Quality Management System for Medical Devices – Requirements for Regulatory Purpose
    (2) GDPMD Good Distribution Practice for Medical Devices
    Conformity Assessment of Medical Device Technical Areas
    (3) MD 0101 Non-active devices for anaesthesia, emergency and intensive care
    (4) MD 0102 Non-active devices for injection, infusion, transfusion and dialysis
    (5) MD 0103 Non-active orthopaedic and rehabilitation devices
    (6) MD 0104 Non-active medical devices with measuring function
    (7) MD 0105 Non-active ophthalmologic devices
    (8) MD 0106 Non-active instruments
    (9) MD 0107 Contraceptive medical devices
    (10) MD 0108 Non-active medical devices for disinfecting, cleaning, rinsing
    (11) MD 0109 Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
    (12) MD 0201 Non-active cardiovascular implants
    (13) MD 0202 Non-active orthopaedic implants
    (14) MD 0203 Non-active functional implants
    (15) MD 0204 Non-active soft tissue implants
    (16) MD 0301 Bandages and wound dressings
    (17) MD 0302 Suture material and clamps
    (18) MD 0303 Other medical devices for wound care
    (19) MD 0401 Non-active dental equipment and instruments
    (20) MD 0402 Dental materials
    (21) MD 0403 Dental implants
    (22) MD 1101 Devices for extra-corporal circulation, infusion and haemopheresis
    (23) MD 1102 Respiratory devices, including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
    (24) MD 1103 Devices for stimulation or inhibition
    (25) MD 1104 Active surgical devices
    (26) MD 1105 Active ophthalmologic devices
    (27) MD 1106 Active dental devices
    (28) MD 1108 Active rehabilitation devices and active prostheses
    (29) MD 1109 Active devices for patient positioning and transport
    (30) MD 1110 Active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
    (31) MD 1111 Software
    (32) MD 1201 Imaging devices utilizing ionizing radiation
    (33) MD 1202 Imaging devices utilizing non-ionizing radiation
    (34) MD 1301 Monitoring devices of non-vital physiological parameters
    (35) MD 1302 Monitoring devices of vital physiological parameters
    (36) MD 1401 Devices utilizing ionizing radiation
    (37) MD 1402 Devices utilizing non-ionizing radiation
    (38) MD 1403 Devices for hyperthermia / hypothermia
    (39) MD 1404 Devices for (extracorporeal) shock-wave therapy (lithotripsy)
    (40) IVD 0305 Human infections: cytomegalovirus, chlamydia
    (41) IVD 0309 Device for self-diagnosis: device for the measurement of blood sugar
    (42) IVD 0403 Immunology
    (43) IVD 0404 Molecular biology
    (44) IVD 0406 Specimen receptacles
    (45) MDS 7001 Medical devices incorporating medicinal substances, according to Directive 2001/83/EC
    Reference Number: (52) MDA.600-1//1/18 JILID 2
    Revision Date: JULY 2, 2018
    (46) MDS 7206 IVDs in sterile condition
    (47) MDS 7210 IVDs utilising material of human origin
    Conformity Assessment by Way of Verification
    (48) VERIFICATION Conformity Assessment by Way of Verification

    Section 10(1) of Medical Device Act 2012 (Act 737) and Regulation 8 of Medical Device Regulations 2012

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