Pure Global, a leader in AI-assisted regulatory consulting, proudly participated in the International Medical Device Exhibition & Conference (IMDEC 2024), held from December 10th to 12th at the Kuala Lumpur Convention Centre (KLCC), Malaysia. This landmark event, under the theme "Unleashing the Power of Medical Technology: Shaping the Future of Healthcare," attracted regulators, healthcare professionals, and industry leaders from across the globe, including over 10,000 trade visitors from 34 countries.

IMDEC 2024, which was held alongside the 28th Global Harmonization Working Party (GHWP) Meeting, was an opportunity to discuss the latest advancements in medical technology, regulatory efficiency, and the role of AI in transforming the industry. One of the most significant highlights was the Malaysian Medical Device Authority (MDA) updates, showcasing their commitment to driving regional leadership in medical device regulation and innovation.

Key Insights from MDA Updates at IMDEC 2024

1. Efficiency in Approvals: Setting a Regional Benchmark
   The MDA’s efficiency in processing over 17,000 medical device applications annually was a key focus. With a quick turnaround of 14-30 working days for product licenses across all device classes (A, B, C, D), Malaysia has set a new regional standard for regulatory speed. The process includes assessments through registered Conformity Assessment Bodies (CABs), streamlined applications, and five-year registration validity, making it a model for other ASEAN nations.

2. Simplified Pricing Structure
   The MDA introduced an affordable and transparent pricing structure for medical device registration, enhancing accessibility without compromising regulatory rigor. This move makes it easier for manufacturers to navigate the regulatory landscape while ensuring that quality standards are upheld.

3. Harmonization Across ASEAN and Beyond
   Malaysia’s regulatory influence is expanding globally. MDA has signed Memoranda of Understanding (MoUs) with regulatory bodies from China (NMPA), Korea (MFDS), Pakistan, and the Philippines to facilitate automatic device approvals across ASEAN countries. MDA certifications are now recognized in global markets like the EU, USA, UK, Japan, Australia, and Canada, positioning Malaysia as a regulatory leader.

4. MedCast 3.0: Streamlining Digital Infrastructure
   The MedCast 3.0 upgrade, expected by 2026, will significantly enhance regulatory efficiencies and reduce operational costs. This new digital infrastructure will introduce auto-renewals and simplify the change management process for manufacturers, further supporting Malaysia's commitment to digital transformation.

5. Compulsory Import Permits
   Starting in January 2025, the MDA will require import permits for medical device distributors, with a three-day turnaround for permit issuance. This ensures that only compliant and properly documented devices enter the market, reinforcing MDA’s commitment to safety and quality.

6. Strengthening Biomedical Workforce
   The MDA emphasized the need to improve the competency of biomedical technicians. To support this, competency certification training will be mandatory, especially for those handling specialized or aesthetic devices.

7. Support for Novel Technology
   To foster innovation, the MDA is offering grants for novel medical technologies. Successful applicants must demonstrate scientific evidence and undergo an Intellectual Property Evaluation (IPE), which will pave the way for commercialization.

8. SaMD Simplification
   The MDA’s simplified process for Software as a Medical Device (SaMD) is another step toward easing regulatory burdens. By allowing manufacturers to submit only the first version for registration and providing a streamlined notification process for subsequent versions, MDA is simplifying the regulatory pathway for SaMD developers.

These insights align seamlessly with Pure Global’s mission to champion responsible AI development and help its clients succeed in an ever-evolving regulatory landscape.

Key Global Networking at IMDEC 2024

The Pure Global team met with prominent figures at the event, including:

• YB Datuk Seri Dr. Dzulkefly Ahmad, Malaysian Minister of Health,

• Dr. Muralitharan Paramasua, Chief Executive of the Medical Device Authority (MDA), and

• Dr. Siew Ee Ling, Laboratory Manager of Makmal Bioserasi – UKM,
  fostering valuable dialogues on regulatory advancements and opportunities for global collaboration.

The team also engaged with Ms. Hoo Ling Lee, Regional CEO of KPJ Healthcare, and Farah Suhami, Deputy General Manager of KPJ Healthcare, exploring how technology-driven solutions can elevate Malaysia’s healthcare infrastructure.

"At the IMDEC 2024 Conference in Kuala Lumpur, Andrew See from Pure Global with Dr. Muralitharan Paramasua, Chief Executive of the Medical Device Authority (MDA), Dr. Siew Ee Ling, Laboratory Manager at Makmal Bioserasi – UKM, YB Datuk Seri Dr. Dzulkefly Ahmad, Minister of Health, Malaysia and other distinguished officials. A moment of collaboration and innovation in the medical device industry!"

AI at the Forefront of Medtech Innovation

At IMDEC 2024, discussions emphasized the transformative role of AI in the medical device sector. Key topics included:

• Unlocking AI’s full potential through collaboration.

• Addressing ethical considerations to build trust and transparency.

• Exploring how AI streamlines device approvals, improves patient outcomes, and enhances operational efficiency.

• Ensuring responsible AI development to balance innovation with regulatory compliance.

These insights align with Pure Global’s mission to drive AI innovation while maintaining regulatory integrity in the evolving healthcare landscape.

Prime Minister’s Vision and the Success of IMDEC 2024

The conference’s closing ceremony was attended by Malaysia’s Prime Minister, Dato Seri Anwar bin Ibrahim, and the Minister of Health, Datuk Seri Dr. Dzulkefly Ahmad. In his speech, the Prime Minister emphasized his commitment to fostering innovation, collaboration, and global harmonization within the healthcare and medical device sectors.

This leadership, combined with initiatives like the development of Makmal Bioserasi – UKM Lab and the adoption of cutting-edge regulatory practices, positions Malaysia as a global hub for MedTech innovation.

A Reflection from the Pure Global Team

Andrew See, Senior Regulatory Affairs Consultant at Pure Global, reflected on the success of IMDEC 2024:

“IMDEC 2024 was a pivotal event, showcasing the transformative role of AI in medical device regulation and MDA’s leadership in driving efficiency and harmonization across ASEAN. It was an invaluable opportunity to engage with industry leaders and regulators, and I’m excited to continue contributing to the future of Regulatory innovation through responsible AI and streamlined regulatory pathways.”

Looking Ahead

Pure Global extends its gratitude to the MDA and the Ministry of Health Malaysia for organizing such a successful event. Our participation at IMDEC 2024 reinforces our commitment to advancing AI-assisted regulatory consulting and supporting manufacturers and healthcare providers in navigating the evolving MedTech industry. Looking forward, we remain dedicated to empowering our partners through innovative solutions, responsible AI practices, and seamless regulatory pathways.

To explore how Pure Global can support your regulatory needs, visit our website at https://pureglobal.com or contact us at [email protected].

Closing Statement

The Pure Global team’s active involvement at IMDEC 2024 underscores our dedication to driving innovation in healthcare through AI-powered regulatory solutions. By fostering collaboration, embracing emerging technologies, and championing ethical practices, we continue to shape the future of medical technology.

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