Please be informed that the PBPP Search System known as Public Search – Malaysia Medical Device Register (MMDR), URL Address: www.mmdr.mda.gov.my has been amended with the name of the new system and URL address namely MEDICAL DEVICE AUTHORITY REGISTER (MDAR), Address URL: https://mdar.mda.gov.my Currently, the search results view only involves licensed establishment data and registered […]
Medical Device Authority (MDA) had released a new guidance for upcoming and existing Conformity Assessment Body in their pursuit to comply with the Medical Device Act (Act 737) and the regulations under it. This updated document is written in conjunction with the current laws and regulations used in this country which include but not limited […]
(1) All medical device shall be: appropriately classified in accordance with the classification rules as specified in FIRST SCHEDULE; and appropriately grouped using the rules of grouping as specified in SECOND SCHEDULE. (2) In the event of any dispute between the establishment and a conformity assessment body over a classification of a medical device, the […]
Any Medical Device placed in the market need to register with Medical Device Authority Malaysia. According to Medical Device Act 2012, Part III, Licence and Permit, Chapter 1, Establishment licence. 16. APPLICATION FOR ESTABLISHMENT LICENCE (1) An establishment may apply for an establishment licence to be granted under this Act by submitting a written application […]
Any Medical Device placed in the market need to register with Medical Device Authority Malaysia. According to Medical Device Act 2012, Part III, Licence and Permit, Chapter 2, Designated medical device permit. 27. REQUIREMENT FOR DESIGNATED MEDICAL DEVICE PERMIT (1) No person shall use or operate any designated medical device unless the person holds a […]
Any Medical Device placed in the market need to register with Medical Device Authority Malaysia. According to Medical Device Act 2012, Part III, Licence and Permit, Chapter 1, Establishment Licence. 15. REQUIREMENT FOR ESTABLISHMENT LICENCE (1) No establishment shall import, export or place in the market any registered medical device unless it holds an establishment […]
Any Medical Device placed in the market need to register with Medical Device Authority Malaysia. According to Medical Device Act 2012, Part II, Registration of Medical Device and Conformity Assessment Body, Chapter 1, Registration of medical device. 6. APPLICATION FOR REGISTRATION OF MEDICAL DEVICE (1) An application for the registration of a medical device shall […]
Any Medical Device placed in the market need to register with Medical Device Authority Malaysia. According to Medical Device Act 2012, Part II, Registration of Medical Device and Conformity Assessment Body, Chapter 1, Registration of medical device. 5. REQUIREMENT FOR REGISTRATION OF MEDICAL (1) No medical device shall be imported, exported or placed in the […]
PEMERIKSAAN PREMIS MENGEDAR DAN MENJUAL PENGIMBAS SUHU INFRARED TANPA SENTUH (INSPECTION ON PREMISE SUPPLYING AND SELLING NON-CONTACT INFRARED THERMOMETERS) Kementerian Kesihatan Malaysia (KKM) melalui Pihak Berkuasa Peranti Perubatan (PBPP) mengambil maklum mengenai isu pengimbas suhu infrared tanpa sentuh yang dikatakan tidak memberi bacaan suhu yang tepat yang dilaporkan oleh beberapa akhbar tempatan baru-baru ini. Kami ingin memaklumkan pengimbas […]
List of Scope of Registration (1) Medical Devices, Non-Active MD 0101 MD 0102 MD 0104 MD 0106 MD 0107 MD 0108 MD 0301 MD 0302 MD 0303 (2) Medical Devices, Active MD 1101 MD 1103 MD 1104 MD 1105 MD 1106 MD 1107 MD 1109 MD 1201 MD 1301 MD 1302 (3) In Vitro Diagnostic […]
