Singapore will simplify the regulatory framework for medical device easing and the approval process will be faster

Recently, Singapore announced that in order to make the approval process faster and allow the latest medical equipment to enter Singapore quickly, the regulatory framework for medical instruments will be simplified and relaxed. There are more than 2,000 kinds of Class A medical instruments that can be added without approval, and the approval process for medium and low-risk Class B medical instruments will also be simplified. The future higher-risk C- and D-grade medical device approval process is also expected to be simplified.

At present, the Health Sciences Board of Singapore divides medical equipment into four levels of A, B, C and D risk levels, and the risk level increases sequentially. Starting from January 2012, the original medium and high-risk C-class and high-risk D-class medical devices were subject to compulsory approval for low-risk B-grade and low-risk A-grade medical instruments. However, since the implementation of the four-month period, people in the industry are worried about it. The most worrying thing is that the cumbersome approval process will delay the use of the latest medical devices in Singapore and many patients will not be able to benefit from the latest medical devices.

If this framework is relaxed, there will be more than 4,700 medical instruments of Class A that can be added to the shelves without approval, an increase of 2,700. At the same time, the approval process for medium-to-low-risk Class B medical devices will also be simplified in September, with about 1750 types, and 40% of the approval fees will also be resolved. As long as you have official approval from any of the United States, the European Union, Australia, Canada, or Japan, you can approve. At the same time, higher-risk Class C and Class D medical instruments are expected to be simplified in the future.