Malaysia Medical Device Regulations

Regulatory Agency

Medical Device Authority (MDA) regulates medical devices in Malaysia.

Medical Device Definition

Medical Device: This means 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 be used, alone or in combination, for human beings for the purpose of

(i) diagnosis, prevention, monitoring, treatment, or alleviation of disease;

(ii) diagnosis, monitoring, treatment, alleviation of, or compensation for an injury;

(iii) investigation, replacement or modification, or support of the anatomy or of a physiological process;

(iv) support or sustaining life;

(v) control of conception;

(vi) disinfection of medical device; or

(vii) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body, which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but that may be assisted in its intended function by such means.

Active Medical Device: Any medical device, operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy but does not include medical devices intended to transmit energy, substances or other elements between an active medical device and the patients, without any significant change.

Medical Device Classification System

International Classification	Risk Level	Examples
Class A	Low risk	Surgical retractors/tongue depressors
Class B	Low–moderate risk	Hypodermic needle/suction equipment
Class C	High- Moderate ris	Lung ventilator / orthopedic implants
Class D	High risk	Heart valves / implantable defibrillator

Regulatory Approval Process

Classification	Approval procedure
Class A	Appoint a local authorized representative in Malaysia. Determine the class of the medical device. Conduct a conformity assessment and collect an evidence of conformity. Appoint a conformity assessment body (CAB) to conduct conformity assessment. Apply to register medical device using MeDC@St with all the required information and relevant supporting documents.
Class B
Class C
Class D
Note: Class A medical devices are exempted from conformity assessment procedures by a Conformity Assessment Body (CAB).