Regulation Medical Devices Malaysia

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Official Portal of Medical Device Authority (MDA) …

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

Medical Device Regulation; Safety Information; Status of Medical Device; Status of Establishment Licensing; Complaints; Regulatory Information Regarding to Healthcare Institution ... , Ministry of Health Malaysia, Level 6, Prima 9, Prima Avenue II, Block 3547, …

Legislation - Medical Device Authority (MDA)

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

Feb 9, 2012

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 control, …

Guidance Document - Medical Device Authority (MDA)

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

Nov 1, 2015

General Medical Device - Medical Device Authority (MDA)

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

Medical Device Regulation - Medical Device Authority (MDA)

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

Medical Device Regulation; Safety Information; Status of Medical Device; Status of Establishment Licensing; Complaints; Regulatory Information Regarding to Healthcare …

Standard - Medical Device Authority (MDA)

https://www.mda.gov.my/doc-list/standard.html

Link to Malaysian Standards Related to Medical Devices (search ISC: Medical Devices and Facilities for Healthcare): 1. Malaysian Standards Online . ... , Ministry of Health …

Malaysia Medical Device Regulations | RegDesk

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

Medical Device Act 2012 (Act 737, Section 2) a) “medical device” means (b) any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related …

Malaysia Issues New Medical Device Regulations

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

The first of the two documents issued by the MDA in Malaysia establishes the duties and obligations of medical device companies. The stipulations in this document will be put into effect on July 1, 2020. The …

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