Medical Device Definition
A medical device in Malaysia 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.
Medical Device Classification System
||Surgical retractors/tongue depressors
||Hypodermic needle/suction equipment
||High- Moderate ris
||Lung ventilator / orthopedic implants
||Heart valves / implantable defibrillator
||Approval of classification of the medical device from the authority: 30 days.
Any information, details, additional documents or device samples medical as required: 90 days (from the date of request by the authority).
|License validity period
||5 Years. One can apply for re-registration within 1 year prior to expiry date via MeDC@St.
Application Fee - 100 RM
Registration Fee - none
Application Fee - 250 RM
Registration Fee - 1000 RM
Application Fee - 500 RM
Registration Fee - 2000 RM
Application Fee - 750 RM
Registration Fee - 3000 RM