A Study on the Legal Environment of Medical Devices and Enhancing the Regulatory System
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Keywords
Specialists, Consequences, Equipment, Medical devices, Medical supplies, Regulation
Abstract
The regulation of medical devices is governed by the Law on Health, the Law on Medicines and Medical Devices, and the Law
on Metrology. While these laws provide definitions of key terms, they lack detailed regulations. The Law on Health addresses
issues related to special licenses, while the Law on Metrology covers metrological inspections. According to the “Methodology
for Assessing the Consequences of the Implementation of Legislation”, as approved by Appendix 6 of Government Resolution
No. 59 of 2016, the implementation of these laws, including the Law on Medicines and Medical Devices, the Law on Health, and
the Law on Metrology, has not fully aligned with reality. This misalignment has failed to regulate certain essential relationships,
leading to negative societal impacts. Consequently, we assessed the implementation and consequences of these laws, considering
the lag between social changes and legal developments. Additionally, comparing medical device regulations with the standard
regulations of countries around the world revealed several differences, starting from the definitions of key terms. We concluded
that there is a need to improve the legal and regulatory environment to establish unified policies and regulations for registration,
quality, safety, optimal asset planning, and maintenance management, particularly for medical equipment.
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References
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