White paper: Medical device registration in Singapore
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联系我们Interested in selling your medical device in Singapore? Singapore is a leading healthcare destination in Asia and its regulatory system shares many similarities with the regulatory process in the European Union. Singapore's process is based on the ASEAN (Association of Southeast Asian Nations) harmonization framework, which is largely derived from the former Global Harmonization Harmonization Task Force (GHTF).
However, there are a number of small differences in the classification rules between Singapore and the EU, and multiple registration routes make it challenging to determine the best path to entry for your device. In this white paper, we'll discuss all aspects of the medical device registration process in Singapore, including:
- Scope of the medical device regulations
- Classification in Singapore
- Routes to market entry
- Grouping
- Registration requirements
- Fees and review times
- Post market notifications
- Change notifications
Learn all this and more in this in-depth white paper.
About the Author:
Michael A. Siano is a Regulatory Affairs Consultant with Emergo, with expertise in global regulatory strategy and EU, Middle East, and South East Asian regulatory affairs. He holds a master's degree in microbiology from the University of Texas at Austin and a bachelor's degree in molecular, cellular & developmental biology from the University of California at Santa Cruz. Prior to entering the regulatory field, he worked in biotechnology and software development.