Medical Device Regulatory Quality Standards - Importance
ISO13458 is becoming widely accepted as the quality
management systems standard for Medical Device manufacturers
throughout the world. This international standard
specifies requirements for regulatory purposes for
medical device manufacturers. The main goal of ISO13458
is to provide a unified model for quality management
system requirements in the international market
since different countries might have different standards.
The standard is based on the ISO9001 process
model (plan-do-check-act) and provides a good
base model for compliance with global regulatory
requirements. In addition to that ISO13458 contains
the requirement applied for medical devices. The
additional requirements are: 4.2.1 Technical File
(DMR), 4.4 Clinical Data, 4.4.1 Risk Analysis,
4.4.4 Safety Requirements.
Medical device is used for human especially for
patient, and it has direct effect to human life
and health. With these characteristics, regulation
for medical device requires higher level of safety
standard than general devices. Therefore attention
is focused on how such companies will manage risk
related to their products and services.
Under the revised Pharmaceutical Affairs Law,
manufacturers and distributors of controlled medical
devices and in vitro diagnostics (ClassⅡ) specified
by the Ministry of Health, Labor and Welfare will
be required throughout Japan to establish a system
that companies with ISO13485 based on third party
certification, which will apply as of April 2005.
A company will no longer be able to trade in the
domestic market without third party certification
of a corporate quality management system which
gives priority to risk management in the provision
of its products rather than the its own assessment.
For manufacturers and distributors of medical
devices and in vitro diagnostics, risk management,
which essentially means the introduction of ISO13485,
will be watershed in deciding whether those companies
will continue to exist in the future.
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