Malaysia Medical Device Regulations

Agency
All medical devices are regulated by Medical Device Authority (MDA) as part of Ministry of Health (MOH).
Medical Device Definition
"Medical device" means - (a) 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 purpose 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;
Classification of Medical Device
International Classification Examples Risk Level
Class A Simple surgical instruments, tongue depressor Low
Class B Hypodermic needles, suction equipment Low-Moderate
Class C Lung ventilator, orthopedic implants High-Moderate
Class D Pacemakers, implantable defibrillators High
Premarket Approval Process *
Class A Class B Class C Class D
Appoint a local authorized representative (LAR).
Ensure products conform to Essential Principle of Safety & Performance (EPSP)
Exempt from Conformity Assessment Reviews (CAB). Special cases may be audited Engage an accredited Conformity Assessment Body (CAB). CAB must be different from CAB in foreign countries.
Complete application on MeDC@St system including: general information, Common Submission Dossier Template (CSDT), Declaration of conformity (DoC), and a certificate of Conformity of the quality management system (QMS) (i) Quality management system (QMS) (ii) System for post-market surveillance (PMS)
Simplified CSDT CSDT; (i) Class B/C: clinical evidence, if required (ii) Class C/D: clinical evaluation
MDA verifies classification and upon approval issues a certificate and assigns a registration number.
Notes
  • Medical device registration certificate is valid for five years
  • All documents can be written in English
  • Recent Update: New mandatory problem reporting policy
  • Current Status: Medical Device Act (Act 737) 2012

* See appendix 1, 2, 3 for details

Appendix 1Appendix 2Appendix 3

Medical Device Act 2012 (Act 737, Section 2)

a) “medical device” means (b) any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article, to be used on the human body, which the Minister may, after taking into consideration issues of public safety, public health or public risk, declare to be a MEDICAL DEVICE by order published in the Gazette.

What is a conformity assessment body (CAB)?

a) A body registered by the Authority to perform specified CA activities to determine whether the relevant requirements in technical regulations or standards are fulfilled

b) CAB is independent of the organization that provides the product and is not a user of the product

c) Authority will monitor the performance of the CAB and, if necessary, withdraw authorization

Parties Involved In Premarket Approval Process

a) Manufacturer conducts CA on:

  1. QMS
  2. PMS system
  3. Summary tech doc (CSDT)
  4. Declaration of conformity (DoC)

b) CAB reviews evidence of conformity
c) Authority reviews & registers medical devices & issues licenses for establishments
d) Requirements For Licensing Of Establishments

 

Source: MDA site

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