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“ We are the only agency that is involved in the industry development of medical devices. We are encouraging high-tech products to be manufactured in Malaysia and exported globally,” said Dr Muralitharan.
This proactive approach is helping local companies move from low-value manufacturing into higher-value, innovative product development that can compete internationally.
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and effectively. MDA conducts awareness campaigns through traditional and digital media as well as face-to-face outreach in hospitals, shopping centres and government institutions.
Dr Muralitharan highlighted the importance of educating consumers, saying:“ We go to all media, such as radio stations and televisions, to talk to the public. We tell them how to identify and buy registered medical devices.”
He also reminded consumers that price should not be the primary factor in selecting medical devices.
“ Don’ t go and buy just because of the price. Buy what is registered and what the quality talks about. Price may not determine the quality,” he advised.
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Sourced from Ketryx’ s webinar
STRATEGIC PLAN 2024-2028
The MDA has charted a bold vision for the future through its Strategic Plan 2024-2028. A key initiative under this plan is the implementation of Unique Device Identification( UDI), which enables traceability of medical devices from the point of entry into the country to the end user.
This is particularly useful for devices such as pacemakers and heart stents, where tracking the device throughout its lifespan is essential for patient safety.
Dr Muralitharan explained:” We want to know who is using it, how long it has been used, especially for critical devices.”
Additionally, the agency is introducing e-labelling and electronic instructions for use, enabling users to access device information by scanning QR codes or barcodes. This reduces reliance on printed materials and ensures information is always up to date.
The MDA is also revising its fee structure
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to reflect current operational costs while ensuring affordability for industry players. This adjustment supports the continued improvement of regulatory services in line with the agency’ s digital transformation goals.
EXPANDING MALAYSIA ' S REGULATORY ROLE
Malaysia is positioned as a global leader in medical device regulation. The MDA is now a member of the International Medical Device Regulators Forum( IMDRF) and actively participates in the Global Harmonisation Working Party( GHWP).
These affiliations allow the agency to stay updated with international standards and promote mutual recognition of device approvals.
Dr Muralitharan emphasised the country’ s ambition, stating:“ We are becoming one of the elite regulators, sitting on par with the United States Food and Drug Administration( USFDA), European Union Medical Device Regulation( EU MDR), Australia’ s Therapeutic Goods Administration( TGA), and Singapore’ s Health Sciences Authority( HSA).”
He added that the ultimate goal is for devices approved by MDA to be accepted in other countries, facilitating faster and more efficient market access.
ADVANCING LOCAL PRODUCTION
In addition to its regulatory function, the MDA actively supports the growth of Malaysia’ s medical device industry. The agency has established a one-stop centre that provides information and assistance related to government grants, financial incentives and R & D support.
SMART REGULATION: The PCCP allows the MDA to fast track approvals for device updates while maintaining strict safety standards.
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“ Don’ t go and buy just because of the price. Buy what is registered and what the quality talks about. Price may not determine the quality.” |
– Dr Muralitharan Paramasua |
MEDICAL HALAL STANDARDS
Recognising the need for ethical compliance in Muslim-majority markets, the MDA has worked closely with the Halal Development Corporation to create voluntary Halal standards for medical devices.
These standards are applicable to items such as surgical sutures, which may contain animal-derived materials.
“ We want to make sure that it does not contain any non-halal ingredients,” Dr Muralitharan said.
Certification is conducted by the Department of Islamic Development Malaysia( JAKIM), while MDA supports the consultation process, guiding companies through the requirements and helping them understand how to obtain certification.
STAKEHOLDER RELATIONSHIPS
MDA maintains strong relationships with industry stakeholders through regular engagement sessions held every four months. These platforms allow medical device associations to discuss new policies, provide feedback and voice their concerns.
Dr Muralitharan highlighted that such cooperation has improved transparency and helped fine-tune the agency’ s regulatory approaches.
“ We meet every four months to discuss industry-related matters and get their input on our draft policies,” he said.
Feedback from the medical device industry has been overwhelmingly positive.
“ Many industries currently support all the initiatives that we are doing. They feel safer mow because enforcement activities are taking place, and there is better control.”
Industry players have welcomed the agency’ s growing support for selfregulation, as well as the availability of clear guidelines and assistance services.
“ They feel relief when they know that there is a one-stop centre that can assist them,” he said.
Through a balance of innovation, regulation and collaboration, the MDA is building a future where rigorous standards and advanced technologies safeguard public health.
Under the leadership of Dr Muralitharan, the agency is enhancing Malaysia’ s reputation as a trusted regulator and medical device hub in the region.
“ Our focus is on quality, safety, and performance, and we are committed to ensuring that Malaysians receive only the best,” he concluded.- The HEALTH
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