1. Overview of Medical Device Regulations in Singapore and Thailand
- Author
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Jain, Khushbu D. and Patil, Sanjay B.
- Abstract
Medical devices are a key element of patient diagnosis and treatment. They could be basic diagnostic tools like tongue depressors and thermometers or complicated, curative implantation like heart valves and coronary stents. Rigorous regulatory requirements are necessary to guarantee that medical devices are well-studied, safe, and well-tolerated in light of their growing use. Many medical devices are in use today, and their marketing is subject to various laws and regulations across different countries. A medical device must have its marketing authorization approved by the relevant regulatory body in order to be sold on the market. The ASEAN (Association of Southeast Asian Nations) Medical Device Directive (AMDD) is an agreement designed for the convergence of medical device laws among ASEAN nations. The current study aims to better understand the medical device registration procedure, fees, and timelines in Singapore and Thailand. This review explains the appropriate local legislation for creating, importing, or selling a medical device in Singapore and Thailand.
- Published
- 2024
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