Malaysia Medical Device Regulations

Regulatory Agency

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

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

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).

Additional Information

Approval timeline

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.

Fees

Class A:

Application Fee - 100 RM
Registration Fee - none

Class B:

Application Fee - 250 RM
Registration Fee - 1000 RM

Class C:

Application Fee - 500 RM
Registration Fee - 2000 RM

Class D:

Application Fee - 750 RM
Registration Fee - 3000 RM

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