| 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 |
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| After the talk, guests adjourned for networking cocktails at the Ballroom foyer. |
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30-31 Oct 2017: AMMI Training on 21 CFR Part 820
| 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 2017: 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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Eksport peralatan perubatan diunjur meningkat 12 peratus
Utusan Malaysia, 2 Ogos 2017
KUALA LUMPUR 2 Ogos – Persatuan Industri Perubatan Malaysia (AMMI) menyasarkan eksport peralatan perubatan negara meningkat 12 peratus kepada RM17.74 bilion berbanding RM15.84 bilion pada tahun lalu.
Pengerusinya, J. Hitendra berkata, unjuran tersebut bersandarkan trend positif eksport sejak tahun 2012 dengan kadar pertumbuhan tahunan sebanyak 13.5 peratus.
Menurut beliau, rantau Asia Pasifik merupakan eksport terbesar negara mewakili 51.5 peratus daripada jumlah keseluruhan diikuti Amerika Utara (27.1 peratus) dan Eropah (19.4 peratus).
“Lebih membanggakan apabila 63 peratus atau RM2.84 bilion bahan mentah yang digunakan untuk menghasilkan produk perubatan datangnya daripada sumber tempatan. Secara tidak langsung perusahaan kecil dan sederhana (PKS) akan menerima manfaat besar daripada perkembangan industri perubatan negara.
“Selain eksport, jumlah pelaburan peralatan perubatan di Malaysia turut meningkat dengan kadar pertumbuhan tahunan 17.1 peratus sejak 2012. Ekosistem industri perubatan yang stabil dan kejayaan syarikat-syarikat perubatan terdahulu menjadi faktor utama syarikat asing datang melabur,” katanya.
Beliau berkata demikian dalam majlis pelancaran Laporan Unjuran Tahunan 2017 Industri Peralatan Perubatan AMMI di sini hari ini.
Dalam pada itu, Ketua Pegawai Eksekutif Lembaga Pembangunan Pelaburan Malaysia (MIDA), Datuk Azman Mahmud memberitahu, antara Januari hingga Jun lalu sebanyak 16 projek dalam bidang peralatan perubatan telah diluluskan dengan nilai RM1.95 bilion.
Artikel Penuh: http://www.utusan.com.my/bisnes/ekonomi/eksport-peralatan-perubatan-diunjur-meningkat-12-peratus-1.510487
© Utusan Melayu (M) Bhd
Medical devices export to grow by 12 per cent for 2017
The Borneo Post, 3 August 2017
KUALA LUMPUR; Exports of medical devices are set to grow by 12 per cent year-on-year to RM17.74 billion in 2017, supported by growing demand, particularly from Asia-Pacific.
According to the Association of Malaysian Medical Industries (AMMI) Medical Device Industry Outlook Report 2017, the region accounted for 51.5 per cent of total exports, followed by North America (27.1 per cent) and Europe (19.4 per cent).
“China, India and the Asean countries are major drivers of growth in the region, as the countries gave more emphasis to healthcare,” he said. Hitendra said this at a media briefing this after launching the report yesterday. Also present was Malaysian Investment Development Authority chief executive officer, Datuk Azman Mahmud.
On the report, Joshi said, 70 per cent of AMMI’s 63 member companies were expected to invest RM1.4 billion in Malaysia in 2017, a sign of a strong investor confidence in the country.
Meanwhile, Azman said, MIDA had approved RM1.95 billion worth of investments in medical devices, involving 16 projects during the first half of the year. Comparatively, he said, 23 projects worth RM1.59 billion were approved in the same period last year, adding that MIDA had approved a total of 41 projects worth RM2.9 billion in 2016, which helped to create 7,300 jobs. “While the medical devices industry sees a bright future ahead, Malaysia is moving towards Industry 4.0, and emerging challenges such as digitalisation, consumer empowerment and new competitors are reshaping the overall landscape,” said Azman.
Hence, he urged industry players to shift their mindset and embrace technology, to keep innovating and to keep conducting research and development to overcome the challenges.
To date, Malaysia has over 200 medical devices manufacturers with investments worth RM14.2 billion. — Bernama
As seen in Borneo Post