Singapore’s HSA Increases Medical Device Registration Fees
Starting July 1st, 2024, Singapore’s Health Science Authority (HSA) has announced that they will increase their review fees in Singapore for all registration routes.
Kenna is the Principal Consultant of Asia Actual in Singapore. A dedicated and experienced regulatory professional with more than 500 successful medical and IVD device registrations to her credit, Kenna has worked with medical devices from the inception of the voluntary regulatory process in 2003.
Since 2007 she has run a regulatory consultant company covering Singapore and Malaysia. Kenna effectively uses her industry knowledge to help clients strategize, prepare and submit new product applications. She is also highly experienced with the creation, documentation and implementation of standard operating procedures and quality systems such as GDPMDS, GDP and GMP. Kenna holds a Pharmacy degree from the University of Science, Malaysia and speaks English, Malay, Hindi and Bahasa Indonesia.
Starting July 1st, 2024, Singapore’s Health Science Authority (HSA) has announced that they will increase their review fees in Singapore for all registration routes.
In April 2022, Singapore’s Health Science Authority (HSA) issued new guidance for registering software as a medical device (SAMD) and Clinical Decision Support Software (CDSS) in Singapore.
Singapore’s Health Science Authority (HSA) recently held a zoom conference call outlining the new requirements for the Special Authorization Routes GN-26 and GN-27 taking effect on April 1, 2022.
Singapore’s Health Science Authority (HSA) to increase review fees in July 2022 by about 3%.
Singapore’s Health Science Authority (HSA) has announced that they will follow many countries example and begin implementing a Unique Device Identifier (UDI) system.
Hand sanitizers are not considered medical devices and therefore, do NOT need approval from the Health Sciences Authority (HSA) in Singapore.
In December 2019, the Health Sciences Authority (HSA) of Singapore’s Ministry of Health released guidelines regarding software registration in Singapore, including a major section dedicated to AI software.
Singapore’s HSA has updated their requirements for software application submissions, requiring the specific version number and iteration of the software to be sold in Singapore.
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