BY KHIRTINI K KUMARAN

The Expo also featured informative technology talks . One was a presentation titled ‘ Medical Device Regulation and Cutting-edge Medical Device Technology ’ by MDA Principal Assistant Director Mariammah Krishnasamy .

MDA is a federal statutory agency under MoH to implement and enforce the Medical Device Act 2012 ( Act 737 ). The main objective of the Act is to address public health and safety issues related to medical devices and to facilitate medical device trade and industry .

“ Regulatory controls are intended to safeguard the health and safety of patients , users and others by ensuring that manufacturers of medical devices follow specified procedures during design , manufacturing and marketing ,” she explained .

CLASSIFICATION OF MEDICAL DEVICES

The risks associated with using medical devices can range from little to significant potential risks inherent in the type of device . The classification of medical devices , she said , was determined by : a . The manufacturer ’ s intended purpose for the medical device b . A set of classification rules

“ These rules will classify medical devices into one of four classes of medical devices . The purposes of risk-based classification are : a . Ensure that the regulatory controls applied to a medical device are proportionate to the risk b . To assist a manufacturer in allocating its medical device to an appropriate risk class c . Regulatory authorities are responsible for ruling upon matters of interpretation for a particular medical device .” Manufacturers must apply the classification rules to each medical device

Table 1

Table 2

according to its intended purpose , which are classified into four classes : A ( low risk ), B ( low-moderate risk ), C ( moderate-high risk ) and D ( high risk ). Table 1 indicates the classification system for general medical devices .

“ All the rules ; non-invasive medical devices rules , invasive medical devices rules , active medical devices rules , and additional rules ; listed in the medical device classification guidance must be considered to establish the proper classification for the device .

“ Note that where a medical device has features that place it into more than one class , classification and conformity assessment should be based on the highest class indicated ,” said Mariammah .

Regarding In Vitro Diagnostic ( IVD ) medical devices , she shared that an IVD classification system has been developed to encourage and support the global convergence of regulatory systems .

“ It is intended for the MDA , Conformity Assessment Bodies and manufacturers . The IVD classification system will also provide benefits in establishing , in a consistent way , an economical and effective approach to the control of medical devices in the interest of public health .

There are four classes of IVD medical devices : Class A , B , C and D . Table 2 below indicates the four risk classes of IVD medical devices .

Conformity assessment and postmarket surveillance medical devices

The Conformity Assessment Body ( CAB ) is authorised to perform specified conformity assessment activities to determine whether the relevant requirements in technical regulations or standards are fulfilled .

Conformity assessment , she explained , is a systematic and ongoing examination of evidence and procedures to ensure the safety , performance , benefit and risk of medical devices . It also ensures manufacturing compliance with essential principles of safety and performance ( EPSP ) and requirements of the Medical Device Act 2012 ( Act 737 ).

“ The classification of a medical device

Note that where a medical device has features that place it into more than one class , classification and conformity assessment should be based on the highest class indicated .”

determines the conformity assessment procedures . Conformity assessment becomes more stringent as the risk of the medical device increases .”

The post-market control is essential after a medical device has obtained market clearance . The MDA Vigilance Unit monitors the post-market surveillance , assuring safety throughout the lifespan of a medical device .

“ Monitoring the performance and reporting the problems associated with the use of medical devices are important components of regulatory control as failures or incidents arising from using a device could not be predicted or prevented at the pre-market stage ,” she explained .

In his opening keynote address , Deputy Minister of Science , Technology and Innovation Datuk Arthur Joseph Kurup , said : “ The digital economy is one of the fastest growing and largest contributors to our GDP . It currently contributes 22.6 per cent to Malaysia ’ s GDP and this is expected to increase to 25.5 per cent by 2025 .

“ Our government has introduced the Malaysia Digital Economy Blueprint and the 4th Industrial Master Plan to support our digital transformation agenda to create high-paying jobs and more business opportunities for Malaysians with our 56 networks roll out on track to achieve its target of 80 per cent network coverage in populated areas by year ’ s end .”

Kurup added that all sectors of the economy , including agriculture , manufacturing , financial services , building and construction , healthcare , transport , security , education and government services , will be able to accelerate the digital transformation .

The Smart Nation Expo 2023 , held alongside EVM ( Electrified Vehicles Mobility ) Asia 2023 , featured 584 exhibiting companies from 23 countries , making it the biggest Expo on 5G smart cities , IR ( Industrial Revolution ) 4.0 , and e-mobility technologies in the region . – The Health