Kuala Lumpur, June 6 2014 – Over 40 delegates from regional and national medical device organisations gathered on 26 May 2014 at the Hilton Hotel, Petaling Jaya, Malaysia for the 2014 Medical Device Forum hosted by BSI (British Standards Institution).
The three main purpose of this year’s event was to update the delegates with the latest EU Regulatory Information, highlight on the upcoming revision changes for the new ISO 13485 Quality Management System for Medical Devices and improve an overall understanding of the newly established unannounced audit practice for the CE Marking products.
Medical Device Act 2013
General Manger for BSI Malaysia, Evelyn Chye, addressed the delegates at the event with an overview of the Malaysia Medical Devices market and the impact of the recent regulatory changes mandated through the Medical Device Act 2013 (Act 737).
“Whilst Malaysia Medical Device market continues to grow at a Compound Annual Growth Rate (CAGR) of 8% from RM 3.7 billion in 2013 to RM 5.1 billion in 2015, it is still relatively small on a global scale, with only about 1% of the overall US market. I believe that post 2015, the market will rise much more as the industry benefits more than the first set of regulations enforced by the MDA that helps improve the quality of medical devices manufactured to be more competitive globally which is likely to be drive by increase in home grown manufacturing of high-end devices,” says Chye.
BSI Medical Device UK expert speakers
The day was followed by invited BSI Medical Device UK expert speakers – Suzanne Halliday, Head of Medical Devices – Training & Ops, Vicky Medley, Head of QMS, Stewart Brain, Head of Microbiology Practice and Dr Qian Liang, BSI APAC Lead.
Halliday, in her presentation, explained about European Clinical Evaluation Requirements and gave an update on EU Relations for Medical Devices whilst Medley provided information and explained that the recent unannounced visits for CE Marketing product manufacturer is the result of post PIP ‘Immediate Action Measures’ and Commission Recommendation published in 2013.
Medley had also shared that a new revision of ISO 13485 Quality Management System for Medical Device (3rd Edition) might be released by the end of the year, should the reviewing committee achieve consensus.
Meanwhile, Dr Qian gave a presentation on best practice for compliment to EU Technical File Requirements to reach conformity with European Notified Bodies.
At the end of the forum, the Medical Device UK experts made a closing remark that regardless of the unannounced visits, they were confident that the medical device organisation will continue to practice their best on a daily basis of which the same sentiment were shared throughout the floor.
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