Category Archives: 2018 Events

Forty AMMI members attended the 29th Annual General Meeting (AGM) and Q2 Meeting held at E&O Hotel Penang. The AGM saw the retirement of AMMI Chairman, Mr Hitendra Joshi and AMMI Director, Mr Suwit Tunlayadechanont. Y.Bhg. Dato’ Dr Haminnuddin (Ideal Healthcare), Mr Paul Brandeis (B.Braun Medical Industries), Mr Tom Mangan (Becton Dickinson) and Mr Andy Lee (Johnson and Johnson) were elected to the AMMI Board of Directors. Mr Christophe Marque was elected by the  AMMI Board as the AMMI Chairman and Mr Yap Kee Keong as Vice-Chairman. This was followed by the Q2 Progress meeting. Invited speaker, Mr Fredrik Nyberg (CEO of APACMed) gave a presentation on “Medtech Industry Update in the Asia Pacific region”. Guests adjourned for CEO Networking after the meeting.

The meeting was held at the new MDA headquarters at Cyberjaya and was attended by 55 AMMI members. MDA was represented by CEO, Encik Zamane and top MDA officials. AMMI presented its policy advocacy on key regulatory issues related to Change Notification for Registered Medical
Device (MDA/GD/0020), Notification of Medical Device Intended for Transit and Registration of Drug-medical Device and Medical Device-drug Combinations Products
Key takeaways:
1. Contract Manufacturers are not subject to the Reminder Notice dated 21 May 2018 on Full Enforcement on Registration Requirement for Medical Devices by 30 June 2018.
2. Export-only devices which do not require Certificate of Free Sales (CFS) are exempted from medical device registration.
3. MDA agreed in principle to remove the labelling requirement for export-only devices (subject to approval from MDA’s Board).
4. Medical device 100% in transit only (“passing the gate”) may be exempted from MDA’s control.
5. Five (5) years’ exemption for entire labelling compliance (not just for medical device registration only.

Thirteen participants attended the AMMI  training on 21 CFR Part 820  held atDorsett Grand Subang.  The training conducted by Mr Frank Ried. The course provided participants with an overview of the FDA and intention of the 21 CFR Part 820, current requirements of the 21 CFR Part 820, working knowledge in application to their organization as well as ability to prepare and host an FDA inspection.

AMMI organised its Global Expert  Sharing Series on Medical Device Packaging : An Overview of Sterile Medical Packaging, Industry Regulations and Packaging Engineering & Design, with two expert speakers, Mr Thiery Wagner (Regulatory Affairs Director, DuPont) and Mr Richard A Jackson (Senior Technical Fellow, DuPont).  Seventy-four participants attended the one-day training held at G Hotel, Kelawai Penang.  The course provided participants with an overview of Sterile Medical Packaging Regulatory/Standards Review, Regulatory Requirements after the new EUMDR; as well as Packaging Engineering and Design, Peel Strength & Microbial Barrier.

Watch our event video highlights here :

DuPont Team with AMMI Chairman, Mr Hitendra Joshi
Left to right : Xuyan Zhu, Nanlin Dang, Kevin Wu , Rahul Yadav, Hitendra Joshi , Thierry Wagner, Richard A Jackson and Vishnu Shankar Vyas

AMMI held its Q1 Progress Meeting at Sofitel Damansara Kuala Lumpur on 8 March 2018. Forty four members attended the meeting. AMMI Chairman, Mr Hitendra Joshi welcomed all present and acknowledge  three new AMMI members to the meeting – Baxter Healthcare (represented by Managing Director, Mr George Kazzi), Smith and Nephew (represented by Country Senior Director, Ms Lillian Lim) and Multivac (represented by Managing Director, SK Tung). After a brief new members’ introduction, AMMI Executive Director, Mr CS Ching, presented the AMMI updates by committee: Government Affairs & Policy, Talent Development, Regulatory & Technical and Membership.