Malaysia Regulation Medical Device

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Official Portal of Medical Device Authority (MDA) …

https://www.mda.gov.my/

Semua establismen yang menjalankan aktiviti meletakkan peranti perubatan dalam pasaran perlu mempunyai Lesen Establismen dan peranti perubatan tersebut perlu didaftarkan seperti yang termaktub dalam Akta Peranti Perubatan 2012 (Akta 737). Orang awam …

Guidance Document - Medical Device Authority (MDA)

https://portal.mda.gov.my/doc-list/guidance-document.html

Nov 1, 2015

Overview of Regulatory Medical Device - MDA

https://portal.mda.gov.my/industry/overview-of-regulatory-medical-device.html

Medical Device Authority (MDA) is a statutory body under the Ministry of Health Malaysia which was established under the Medical Device Authority Act 2012 (Act 738) to …

Legislation - Medical Device Authority (MDA)

https://portal.mda.gov.my/doc-list/legislation.html

Feb 9, 2012

General Medical Device - Medical Device Authority (MDA)

https://portal.mda.gov.my/industry/medical-device-registration/general-medical-device.html

An application to register medical devices may be made according to their grouping. For general medical devices, they may be grouped into one of the following categories as: Single; Family; System; …

MEDICAL DEVICE GUIDANCE DOCUMENT - Medical …

https://mda.gov.my/ms/dokumen/guidance-documents/805-8-csdt/file.html

If the labelling, packaging and IFU of the medical device for sale in Malaysia is identical to that approved by each reference agency, a declaration that the labelling, packaging and …

Medical Device Regulation - Medical Device Authority (MDA)

https://www.mda.gov.my/profesional/overview-of-mdr.html

Custom-Made Medical Device; Special Access Medical Device; Clinical Research Study; List Of Clinical Investigational Use Studies; Product Classification; …

Malaysia Issues New Medical Device Regulations

https://www.regdesk.co/malaysia-issues-new-medical-device-regulations/

The Medical Device Authority ( MDA ), a special division of the Ministry of Health Malaysia responsible for medical device regulation, has announced new rules introducing additional obligations for medical …

Malaysia Medical Device Regulations | RegDesk

https://www.regdesk.co/resource-library/malaysia/

"Medical device" means - (a) any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to …

Malaysia - Medical Devices Regulations

https://www.artixio.com/post/malaysia-medical-devices-regulations

Malaysia - Medical Devices Regulations Regulatory Staffing About Us Xpress Careers Contact Home Regulatory Affairs Quality MedTech Testing Services …

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