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The medical industry is driven by
government regulations. Regulations, in turn, are the outcome of
a country’s state of developmental phase, national policies and
general healthcare aims. In the past, these regulations evolved
independently in each country, and took years to improve and
reform to a stage which can effectively govern the medical
activities within that country. With rapid globalization, the
evolvement of regulatory processes is now accelerating,
especially in developing economies like Asia Pacific and South
America. The World Health Organization has taken on a lead role
to audit and recommend best practices for health care policies,
which also includes the policy process to ensure access to high
quality medical devices.
This presentation attempts to link
the guiding principles from World Health Organization on medical
devices to activities of the Global Harmonization Task Force,
and how these will influence the regulatory progress. It will be
beneficial for medical device manufacturers and other value
chain players within the medical industry to understand the
guiding principles which World Health Organization has
developed, and keeping abreast with the activities of the Global
Harmonization Task Force, who in turns influence the Asian
Harmonization Working Party. The harmonization work is
beneficial to the region as it allows better accessibility of
medical care across countries by removing non-trade barriers and
creates more opportunities of export growth to the countries.
Understanding of these updates will allow medical device
manufacturers and their supply chain to better anticipate what
the future regulatory landscape would be, and be prepared for
the eventualities.
Some of the key standards that
have been adopted internationally are ISO 10993 Biological
Evaluation of Medical Devices and ISO 11607:2006 Packaging for
Terminally Sterilized Medical Devices. A brief explanation is
given of these 2 standards, together with the benefits of
complying to these standards. |
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Chew Ee Ke
– Market Development Manager, Eastman Chemicals Asia Pacific.
Responsible to develop the medical device and medical packaging
industry for Eastman Chemical’s Specialty Plastics Business in
the Asia Pacific Region. Previously worked in Becton Dickinson
as a product Value Stream Leader and Strategic Sourcing Manager,
responsible for manufacturing, contract manufacturing and direct
materials sourcing. Mr Chew is a certified Six Sigma Black Belt
and certified Lead Auditor for ISO 9001. |
Mr. Chew Ee
Ke
Market Development Manager
Eastman Chemicals Asia Pacific, Singapore |
