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
Class B
Class C
Class D |
|
Note: Class A medical devices are exempted from conformity assessment procedures by a Conformity Assessment Body (CAB). |
|
Additional Information
Approval timeline |
Approval of classification of the medical device from the authority: Class A- 1month, Class B, C, and D- 2 months. |
License validity period |
5 Years. One can apply for re-registration within 1 year prior to expiry date via MeDC@St. |
Fees |
Class A:
Class B:
Class C:
Class D:
A medical device that contains a medicinal product – 5000 RM |
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