|AMMI held its first CEO Evening Talk on Industry 4.0 for the Medical Device Industry at the Equatorial Hotel Penang . The objective of this event is to provide insight and updates, as well as facilitate open discussion among top management level representatives of AMMI Member Companies and key stakeholders on the impending age of Industry 4.0 in the Medical Device Industry. Forty-five members and guests attended the event, which started with a welcome speech by AMMi Chairman, Mr Hitendra Joshi. Dr Juergen Schloesser, Vice President, Operations & Head, Centre of Excellence, Intravenous-Access, B. Braun Medical Industries Sdn Bhd. gave a presentation on Industry 4.0 for the Medical Device Industry . This was followed by a Panel Discussion led by Mr Martin Tonko from Roland Berger. Panel members include Dr Juergen Schloesser, Mr YJ.Lim, Regional President , Plexus APAC, Mr Michel Van Crombrugge, Country Manager, Paramit Malaysia Sdn Bhd and Mr Dave Mitchell, VP Operations, Boston Scientific Medical Device (Malaysia) Sdn Bhd|
|After the talk, guests adjourned for networking cocktails at the Ballroom foyer.|
|AMMI organised a training on 21 CFR Part 820 at the E&O Hotel from 30-31 October 2017. Seventeen (17) participants from seven (7) companies attended the training. The training was conducted by industry expert, Mr Frank Ried and provided participants with an overview of the FDA and intention of the 21 CFR Part 820. It also covered 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 the training on Medical Device Process Validation Training at G Hotel Gurney from 23-24 November 2017. Forty seven (47) participants from twelve (12) companies attended the training which was conducted by industry expert, Mr Gobu Devarajan. The course provided regulatory/quality systems professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation requirements of the FDA’s Quality System Regulation, ISO 13485 and the GHTF Validation guidance N99-10 while offering information on how to implement an effective validation program.|
|AMMI organised its Global Expert Training Series on Industrial Sterilization for Medical Devices at G Hotel Gurney from 15-16 November 2017. Forty two (42) participants attended the training, conducted by Richard Cowman and Ms Jayanthimala Authikesavalu from STERIS. The two day training cum workshop provided participants with a comprehensive overview of the options available for the sterilization of medical devices. The training outlined the sterilization modalities available to the medical device industry as well as giving participants an understanding of the laboratory testing associated with the sterilization of medical devices. A combination of presentation and workshop activities were used to explore real practical challenges and promote an interactive learning environment.|
|The Association of Malaysian Medical Industries (AMMI) and Malaysian Investment Development Authority (MIDA) held its joint launch of the AMMI Medical Device Industry Outlook Report at MIDA Sentral, Kuala Lumpur on 2 August 2017. MIDA CEO, Y. Bhg Dato’ Azman Mahmud officiated the launch . The event was attended by MIDA top management team, AMMI Board of Directors and Members, as well as invited guests and media.|
|Y. Bhg. Dato’ Azman Mahmud gave a welcome speech, noting that the presence of many MNCs has contributed to the development of a comprehensive local supply chain benefitting many local players. AMMI Chairman, Mr Hitendra Joshi then gave a presentation of the AMMI Medical Device Outlook Report 2017. The report highlighted that AMMI recorded an outstanding value-added ratio of 57% in manufacturing medical devices in Malaysia. Equally impressive is the fact that some RM2.84 billion or 63% worth of raw materials and services were locally sourced from within the country. This reflects AMMI’s commitment in supporting government initiatives to develop local small and medium-sized enterprises (SMEs). In addition, over 70% of AMMI members surveyed are expected to invest a total of RM1.4 billion in the country in 2017 – a strong signal by way of investor confidence in the Malaysia.|
|The launch was followed by a joint press conference, attended by Y.Bhg Dato’ Azman Mahmud, Y.Bhg Datuk N. Rajendran (MIDA Deputy CEO II), Mr Hitendra Joshi and Mr H.T Eow (AMMI Secretary of the Board); and over 20 media/ press members. Guests then adjourned for networking lunch after the press conference.|
|From left to right : YBhg Datuk N. Rajendran (MIDA Deputy CEO II) , Y.Bhg Dato’ Azman Mahmud (MIDA CEO), Mr Hitendra Joshi (AMMI Chairman) and Mr H.T. Eow (AMMI Secretary of the Board)|
Exclusive Dialogue Session between AMMI Members and MIDA Top Management
|In the afternoon, there was an exclusive dialogue session between MIDA top management and AMMI members, to discuss important issues faced by the medical device industry.|
|The AMMI Medical Device Industry Outlook Report 2017 is now available for sale.
Please click here to purchase.