Webb15 mars 2024 · Product Name. Product Registration. Recall Class. Reason of Recall. Recalling Establishment. Establishment License. 15/03/2024. MDA/Recall/P0128-60818328-2024. ... MDA-4259-WDP123 * The information contained in the Medical Device Authority Recall database is released under Regulation 7(8) ... WebbThere are 3 basic steps to registration: Foreign manufacturers need to appoint an Authorized Representative (AR) in Malaysia, who will register their devices. The AR will …

Malaysia Medical Device Registration - MDA Approval

Webb28 dec. 2024 · Medical Device Registration General Medical Device General Medical Device For any enquiries, kindly contact Registration Unit: Email: registration [AT] mda [DOT] gov [DOT] my Phone Number : Registration Unit +603 8230 0376 or Pn. Aidahwaty bt Ariffin +603 8230 0341 Calendar Mesyuarat Jawatankuasa Teknikal Pendaftaran UMUM … Webb1 nov. 2015 · These Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it. ironton 150 lb pound drywall lift

MEDICAL DEVICE RECALL LISTING MARCH 2024 - Medical Device Authority (MDA)

Webb5 dec. 2024 · Only a simplified overview of the main steps for registration is provided here. Step 1 Determine the classification of your device according to the MDA’s classification rules. Step 2 Appoint a local Authorized Representative (AR) to manage your medical device registration and interact with the MDA on your behalf. Step 3 WebbProduct registration applications for medical devices submitted to HSA must be prepared in the format set out in the CSDT document. This guidancASEAN e document must be read in conjunction with the ASEAN CSDT document, the GN-15 Guidance to Medical Device Product Registrationand other relevan t guidance documents. WebbThe MDA implements and enforces the Medical Device Act 2012 (Act 737). All medical devices that are imported, exported or placed on the market in Malaysia whether … ironton 1500 winch