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 […]
Date: 16-19 March 2020Venue: Bilik Seminar 1, Level G, Prima 9, 63000 Cyberjaya Trainings Sanctioned By The Medical Device Authority are now opened for registration. The trainings will be organized in MARCH 2020. For more details, please visit: Proficiency Training (CAB)
Date: 13-15 October 2020Venue: MITEC, Kuala Lumpur The events Malaysia Medical Device Expo (MEDEX) is an initiative by Medical Device Authority (MDA) to bring light to latest innovative technologies and advances of global medical devices. The objective is to create an insightful one-stop centre for medical devices solutions. Medipharma offers an all-encompassing trade platform for […]
