Category Archives: Uncategorized

10 September 2026: AMMI Global Expert Sharing on Navigating European Market Access with CE Marking & Clinical Evaluation

AMMI organised a full-day Global Expert Sharing seminar, “Navigating European Market Access with CE Marking & Clinical Evaluation,” led by Mr Richard Holborow (BSI) at Olive Tree Hotel, Penang. Over 50 AMMI members attended the event.

The seminar covered EU regulatory updates for CE marking, an overview of Clinical Evaluation and ISO 14155:2020, Clinical Evaluation under the EU MDR, preparation and content of the Clinical Evaluation Report (CER), and MDR Notified Body expectations for clinical evidence, with practical guidance on aligning clinical strategies to current regulatory requirements.

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15 September 2026: Ministry of Finance Budget 2027 Dialogue with AMMI Members

💬 Ministry of Finance Budget 2027 Dialogue with AMMI Members

On 15 September 2026, the Association of Malaysian Medical Industries (AMMI) organised the Budget 2027 Dialogue with the Ministry of Finance (MOF) at Abbott Penang, bringing together AMMI members and representatives from government agencies for a direct engagement with the Ministry.

The session was graced by YB Senator Datuk Seri Amir Hamzah Azizan, Minister of Finance II, and provided a valuable platform for AMMI members to share industry perspectives and priorities relevant to Malaysia’s MedTech sector.

Through engagements such as this, AMMI continues to facilitate meaningful dialogue between the medical device industry and key government stakeholders, supporting collaboration towards the continued growth and development of Malaysia’s MedTech ecosystem.

AMMI extends its sincere appreciation to the Ministry of Finance and YB Senator Datuk Seri Amir Hamzah Azizan for engaging with our members, and to all AMMI members for their valuable participation and contributions.

A special thank you as well to the management of Abbott Penang for their warm hospitality and for graciously hosting the event.

 

15 September 2026: AMMI MOF Dialogue at Abbott Penang

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8 September 2026: AMMI OpEx Johor Factory Visits

On 8 September, AMMI organised a factory visit for 25 members as part of its Operations Excellence Pillar.  Members toured the facility to gain direct insights into Insulet’s advanced medical device manufacturing operations and its innovative Omnipod® diabetes care delivery system.

AMMI members also visited Oliver Healthcare Packaging, where members explored the facility and warehouse firsthand.  Visitors gained valuable exposure to Oliver Healthcare’s advanced manufacturing processes, innovative packaging solutions, and regional capabilities.

We sincerely thank Insulet and Oliver Healthcare Packaging for hosting the members and sharing valuable insights to drive continuous improvement across the medical technology ecosystem.

27 August 2026: IMDEC Medical Device Regulatory Forum

IMDEC 2026 MEDICAL DEVICE REGULATORY FORUM

Date: 27 August 2026 (Thursday)

Time: 2:00 pm – 5.30 pm

Venue: Stage 1, Hall 5, KL Convention Centre, KLCC

TIME AGENDA
2:00 PM Welcome Address / Opening
by Y. Bhg Datuk Ts Dr. Muralitharan Paramasua Chief Executive, Medical Device Authority (MDA) Malaysia
2:15 PM Regulatory Update: Why GHWP Change Management Guidelines and How It Works in Managing Innovative Devices and Product Lifecycle
by Mr Sharad Mi. Shukla, Chairperson, Regulatory Affairs Committee, APACMed and Senior Director, Regulatory Affairs, APAC, Johnson & Johnson MedTech
2:45 PM MDA New Change Management Guidance: What is Different in the New Change Management Guidance and Medcast 3.0 Application Process
by Pn Aidahwaty M. Olaybal, Division Director, Pre-Market Control Division (BKPP), Medical Device Authority (MDA)
3:15 PM MDA Flow Chart Description
How to read the flow chart from MDA guidance
by En. Muhammad Hazman bin Mohd Zaini, Senior Assistant Director of Pre-Market Control Division, Medical Device Authority (MDA)
4:00 PM Case Studies Flow Chart – Software
View from Industry Assessment and Preparation for Change Based on Flow Chart
by Ms Athirah Abu Bakar, Medtronic Malaysia Sdn Bhd
4:20 PM Case Studies Flow Chart – General Medical Device
View from industry assessment and preparation for change based on flow chart
by Ms Law Ching Yee, Malaysia Medical Device Association (MMDA)
4:40 PM Case Studies Flow Chart – IVD
View from Industry Assessment and Preparation for Change Based on Flow Chart
by Ms Debra Anthony Peter, QIAGEN Biotechnology Malaysia Sdn Bhd
5:00 PM Q&A Session and Wrap Up

 

1 October 2025: AMMI Gala Dinner

AMMI Gala Dinner 2025 was held on 1 October at G Hotel Gurney, Penang, welcoming 380 attendees, including AMMI members and key stakeholders from the medical device industry, for an evening of camaraderie, networking, and celebration. The highlight of the night was the presence of the Chief Minister of Penang as Guest of Honour, underscoring the state’s strong commitment to supporting the growth and innovation of the medical device sector.

AMMI Gala Dinner 2025 (Collection 1)

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