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馬來西亞管理醫療器材的主管單位為衛生部(Ministry of Health Malaysia)轄下的醫療器材管理局（The Medical Device Authority, MDA）。2012年公告之醫療器材法案(Medical Device Act 2012 (Act 737) 是目前馬來西亞醫療器材管理依據。該法明確定義醫療器材與風險等級，並詳細規範醫療器材產品註冊、工廠管理與許可執照、以及第三方認證機構(Conformity assessment body, CAB)的角色與規範。
所規範者包含一般醫療器材與體外診斷醫療器材，依風險等級由低到高分為A、B、C、D。
一、Legislation
1. Medical Device Act 2012 (Act 737), 09/02/2012
2. Medical Device Regulations 2012 [P.U. (A) 500], 31/12/2012
二、Guidance Document
1. Definition of Medical Device, March 2014
2. Rules of Classification for General Medical Devices, March 2014
3. The Essential Principles of Safety and Performance of Medical Devices, March 2014
4. In-Vitro Diagnostic (IVD) Medical Device Classification System, July 2013
5. Conformity Assessment for Medical Device, October 2017
6. Essential Principles of Safety and Performance of IVD Medical Devices, July 2013
7. Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products, June 20th 2019
8. Requirements for Labelling of Medical Devices, November 2018
9. Licensing for Establishment, May 2016
