| 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. |
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23-24 Nov : Medical Device Manufacturing Process Validation Training
| 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. |
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15-16 Nov 2017 : Industrial Sterilization of Medical Devices Training
| 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. |
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2 August 2017 – Launch of AMMI Medical Device Industry Outlook Report 2017
| 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. |
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| 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. |
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| 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. |
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| 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) |
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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. |
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| The AMMI Medical Device Industry Outlook Report 2017 is now available for sale. Please click here to purchase. |
25 May 2017 – AMMI EGM, AGM , Q2 Progress Meeting and Networking
| AMMI held its Extraordinary Meeting, 28th Annual General Meeting and Q2 Progress Meeting at G Hotel Kelawai Penang on 25th May 2017. The meeting was attended by 39 members from 27 companies. The AGM saw the retirement of Mr Lim Bee Leong (Bemis Asia Pacific) as Vice-Chairman and Mr Chin Hock Meng (Abbott) as Treasurer. Mr John Ward (SteriPack Asia Pacific) and Mr Christophe Marque (Stereo) were elected as Vice-Chairmen, Mr H.T Eow (Abbott) as Secretary of the Board and Mr Yap Kee Keong (Texchem Group) as Treasurer . Mr Suwit Tunlayadechanont (Steris), Mr Michel Van Crombrugge (Paramit) and Mr Michael Goh (Johnson and Johnson) were also elected to the Board as Directors. After the EGM and AGM, members continued with the Q2 Progress Meeting, where Executive Director, Mr CS Ching updated members on upcoming activities and events, as well as reported on Q1 activities. | ||
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| During the progress meeting, a special appreciation session was held for outgoing Vice Chairman, Mr Lim Bee Leong (who unfortunately could not attend the meeting) and Treasurer, Mr Chin Hock Meng. Mr CS Ching read the citation, accompanied by a short slide presentation for both Mr Lim Bee Leong and Mr Chin Hock Meng. Chairman, Mr Hitendra Joshi, then presented a token of appreciation to Mr Chin Hock Meng. | ||
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| Tea-Break before the next session continues… | ||
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| After the Q2 Progress Meeting, invited speaker, Mr Nishith Desai , Chair for ASEAN COE of RA committee of APACMed and Director of Quality and Regulatory of South East Asia, Medtronic Singapore, gave a presentation on “Asia Pacific Regulatory Updates” . | ||
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| Chairman, Mr Hitendra Joshi presented a Letter of Appreciation to Mr Nishith Desai for his insightful presentation. | ||
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| Guests then adjourned to the Gravity Rooftop Lounge for a cocktail networking session, with invited guests from MIDA Penang and Invest Penang. | ||
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