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MEDICAL DEVICE AUTHORITY (MDA) - Coggle Diagram

- - - - Untuk menjadi badan kawalselia peranti perubatan yang diiktiraf di peringkat antarabangsa yang menyediakann perkhidmatan kelas dunia, peneraju hab peranti perubatan untuk persekitaran penjagaan kesihatan yang selamat dan berkesan bagi negara pada tahun 2023.
    - - Kawalan dan Penguatkuasaan yang efektif.
        
        Didorong oleh teknologi dan kompetensi sumber manusia.
        
        Keterlibatan (engagement) pelanggan dan stakeholders.
        
        Mewujudkan dan mengukuhkan hubungan antarabangsa. (MOU/MRA)
    - - Integrity, Effective, Professional
  - - - To regulate, control, and monitor of all matters related to medical devices, stakeholders and Conformity Assessment Bodies.
      - To be responsible for assessment and approval of application for medical devices registration, licensing of medical device establishment and CABs.
      - To identify and determine the standards for compliance with conformity assessment procedures of medical devices
      - To control, supervise and monitor contents and materials used in advertisement of medical devices.
      - To control, supervise and monitor distribution records of medical devices.
      - To supervise and monitor post-market surveillance and vigilance system.
      - To control, monitor and investigate complaints and mandatory adverse event reporting of medical devices.
      - To control, supervise and monitor field corrective action of medical devices.
      - To control, supervise and monitor recalls of medical devices.
      - To control, supervise and monitor calibration, maintenance, operation, decommissioning and disposal of medical devices.
      - Control of usage and operation of designated medical devices.
      - To communicate authoritative and reliable information and advice to improve public and professional awareness.
      - To encourage technical innovation and technology transfer for the advancement of medical devices technology.
      - To encourage and facilitate trade liberalization of medical devices with other countries.
      - To promote cooperation and establish Mutual Recognition Agreement amongst countries on medical devices regulation.
      - To monitor and impose fee for medical devices registration, licensing of establishment involved with marketing of medical devices and operational and usage permits for designated devices.
  - - - MDA serves the Malaysian medical device sector. It enforces the Medical Device Act 2012 as a federal statutory agency under the Ministry of Health Malaysia (Act 737). The Legislation aims to improve medical device trade and public health and safety.
      - The Cabinet approved medical device regulatory programme development and execution in February 2005. On February 9, 2012, the Gazzete issued the Medical Device Authority Act 2012 (Act 738) and Medical Device Act (Act 737) following the Cabinet decision.
      - Founded under Act 738 on 15 March 2012 and began operations on 16 June 2012.
      - Function of MDA
        
        Registration of medical device
        
        Registration of CAB
        
        Issuance of Establishment License
        
        Issuance of Free Sales Certificate and Manufacturing Certificate
        
        Training & Awareness
  - - - AKTA BADAN-BADAN BERKANUN (TATATERTIB DAN SURCAJ)
        2000 (AKTA 605)
        AKTA SURUHANJAYA PENCEGAHAN RASUAH MALAYSIA 2009
        (AKTA 694)
        PENGURUSAN KONFLIK KEPENTINGAN (CONFLICT OF
        INTEREST)
    - - MEMBERIKAN TAAT SETIA, PEMATUHAN UNDANG-UNDANG DAN PERATURAN
        , MENJAGA IMEJ DAN NAMA BAIK
    - - TATACARA BERPAKAIAN, PEKERJAAN LUAR, ASET DAN HARTA KERAJAAN
        , KERAHSIAAN PERKARA TERPERINGKAT, KEHADIRAN BERTUGAS
        , PERISYTIHARAN HARTA , KETERHUTANGAN KEWANGAN YANG SERIUS, KEGIATAN POLITIK
        PERNYATAAN AWAM, PENERIMAAN DAN PEMBERIAN HADIAH, PENERIMAAN DAN PEMBERIAN KERAIAN
        , PENGARUH LUAR ATAU SURAT SOKONGAN, GANGGUAN SEKSUAL
        , PENYAHLAHGUNAAN DADAH, PERLAKUAN RASUAH
        , KEGIATAN JENAYAH
- - - - To organize and manage the Medical Device Authority (MDA) website with certain matters such as information checking, updates and manage basic ICT tasks.
  - - - Offer legal advice, opinions, and direction to Authority Members, the Chief Executive Officer, and all other Authority officers and servants, or any other body as instructed by the CEO.
      - Advise the Authority on all legislation and policies, including the Medical Device Act 2012 (Act 737), the Medical Device Authority Act 2012 (Act 738), Statutes, Rules, and Regulations made thereunder, government circulars, and other administrative directives governing the Authority, to ensure compliance with the Authority's policies and statutory requirements.
      - Write, review, and finalise legal documents and advise on all Authority contractual and non-contractual legal matters.
      - Advise and aid the authority's lawyers in actions against or on behalf of the Authority.
      - If statutory violation occurs, initiate and aid prosecution.
- - - - Includes the definition of medical devices, the registration and licensing of medical devices, the establishment of a Medical Device Authority, and the regulation of the import, export, sale, and distribution of medical devices in Malaysia. The act also outlines the penalties for non-compliance with the regulatory requirements, including fines and imprisonment. Overall, the Medical Device Act 737 is designed to ensure that medical devices sold and used in Malaysia are safe, effective, and of high quality.
      - Registration of Medical Device
        Establish Licences
        Designated Medical Device Permit
        Duties & Obligations of licenses or permit holder
        General duty
        Export Permit .
        
        Registration: All medical devices must be registered with the Medical Device Authority (MDA) before they can be imported, exported, or supplied in Malaysia.
        
        Classification: Medical devices are classified into four classes based on their level of risk. Each class has different requirements for registration and conformity assessment.
        
        Conformity assessment: Medical devices must undergo a conformity assessment process to demonstrate their safety and effectiveness. This process includes testing, quality control, and certification by a notified body.
        
        Labelling and advertising: Medical devices must be labelled with clear and accurate information about their intended use, instructions for use, and potential risks. Advertising of medical devices is also regulated to ensure that it is not misleading or false.
        
        Post-market surveillance: The MDA conducts post-market surveillance activities to monitor the safety and performance of medical devices in use. This includes adverse event reporting, product recalls, and market surveillance.
      - Classification of Medical Devices
        
        Class I: These are low-risk devices, such as bandages, tongue depressors, and basic surgical instruments. They are subject to general controls, such as registration with regulatory authorities and adherence to quality management standards.
        
        Class II: These are moderate-risk devices, such as infusion pumps, X-ray machines, and contact lenses. They require more regulatory controls than Class I devices, such as pre-market notification to regulatory authorities and adherence to special labeling and performance standards.
        
        Class III: These are high-risk devices, such as pacemakers, heart valves, and implantable defibrillators. They require the most stringent regulatory controls, such as pre-market approval from regulatory authorities, clinical testing, and strict manufacturing standards.
      - Type of medical devices
        
        Type B: These devices provide the highest level of protection against electrical shock. They are used in situations where patients are particularly vulnerable to electric shock, such as during surgical procedures. Type B devices have a protective earth connection and double insulation.
        
        Type BF: These devices provide an intermediate level of protection against electrical shock. They are used in situations where patients are less vulnerable to electric shock than in surgical procedures, but where electrical safety is still important, such as in diagnostic procedures. Type BF devices have a lower leakage current than Type B devices.
        
        Type CF: These devices provide the lowest level of protection against electrical shock. They are used in situations where patients are not particularly vulnerable to electric shock, such as in respiratory or anesthesia equipment. Type CF devices have a very low leakage current and additional insulation.