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Medical Device Regulatory System - Coggle Diagram
Medical Device Regulatory System
MEDICAL DEVICE ACT 2012 (Act 737) & MEDICAL DEVICE AUTHORITY 2012 (Act 738)
An Act to regulate medical devices, the industry and to provide for matters connected thereto
Enacted by the parliament
Divide into 6 Part
Part I - Preliminary
provides the short title and commencement of the Act and interpretation
Section 1(1) - sited as the Medical Device Act 2012
Section 1(2) - This Act comes into operation on a date to be appointed by the Minister by notification in the Gazette
Section 2 - Provides interpretation of terminologies used in this Act
Part II - Registration of Medical Device and Conformity Assessment Body
Provides Requirements for registration
Chapter 1 - Registration of medical device
Section 3 - Classification of Medical Device
Section 4 - Manufacture's obligation
Section 5 - Requirement for registration of medical device
Section 6 - Application for registration of medical device
Section 7 - Registration and refusal to register medical device
Section 8 - Power to impose additional conditions and to vary or revoke conditions
Section 9 - Power to cancel registration of medical device
Chapter 2 - Registration of Conformity Assessment Body
Section 10 - conformity assessment body
Section 11 - requirement for registration of conformity assessment body
Section 12 - Registration and refusal to register conformity assessment body
Section 13 - power to impose additional conditions and to vary or revoke conditions
Section 14 - power to cancel registration of conformity assessment body
Part III - License and Permit
Chapter 5 - Export permit
Section 45 - export permit
Section 46 - revocation of export permit
Chapter 4 - General duty
focusing on usage and marketing perspectives
Section 43 - usage. operation, maintenance, etc., of medical device
Section 44 - advertising
Chapter 3 - Duties and obligation of licensees or permit holders
distribution records
post-market surveillance and vigilance
complaint handling
mandatory problem reporting
field corrective action
recall
Chapter 2 - Designated Medical Device Permit
Section 26 - designated medical device
Section 27 - requirement for designated medical device permit
Section 28 - application for designated medical device permit
Section 29 - additional information or document
Section 30 - grant or refusal of designated medical device permit
Section 31 - compliance with designated medical device permit conditions
Section 32 - power to impose additional conditions and to vary or revoke conditions
Section 33 - suspension or revocation of designated medical device permit
Section 34 - surrender of designated medical device permit
Section 35 - renewal of designated medical device permit
Section 35 - effect of suspension, revocation, surrender or non-renewal of designated medical device permit
Chapter 1- Establishment license
Section 25 - effect of suspension, revocation, surrender or non-renewal of establishment license
Section 24 - renewal of establishment license
Section 23 - surrender of establishment license
Section 22 - suspension or revocation of establishment license
Section 21 - transfer of establishment license
Section 20 - power to impose additional conditions and to vary or revolve conditions
Section 19 - compliance with establishment license conditions
Section 18 - grant or refusal of establishment license
Section 17 - additional information or document
Section 16 - Application for establishment license
Section 15 - requirement for establishment license
Part IV - Appeal
Part V - Enforcement
provides requirement for enforcement activities
cost recovering during enforcement activities
power to require attendance of persons acquainted with case, arrest and take sample
accessibility to the information
admission of statement in evidence
procedure on search and seizures with/without warrant
appointment of analyst
power given to the authority to carry out enforcement activities
Part VI - General
register
confidential business information
public disclosure
emergency response plan and assistance from multi-agencies in emergency
compounding of offences
prosecution
offense by body corporate
offence by partner, agent or servant
service of document
false declaration
power to exempt
general penalty
regulation
savings and transitional
To address public health & safety issues
availability of pre-market control to assess safety, effectiveness and quality of medical devices
adequate information for the public and health professionals to make informed choices on medical devices
control over the usage
post-market reporting system to identify and monitor medical devices with problems in the market available
To facilitate medical device trade & industry
provide a favourable environment for the growth of medical device industry
facilitate our local manufactures to market their products globally
The Regulatory Framework
Pre-Market
Ensure the products conform to EPSP
Establish appropriate quality system for manufacturing their products
Collect evidence of conformity
Placement on-Market
Medical Device Registration
Establishment Licensing
Post-Market
Surveillance & Vigilance
Usage & Maintenance