中文|English
中文|English
How long is the processing time for D-class medical device registration in Singapore HSA?
Release time：2025-01-16 11:44:36 The author: source:
Completeness of the application: If the required documents are complete and correctly submitted, the process will be faster. Incomplete or incorrect submissions may cause delays as HSA may request additional information.

The processing time for D-class medical device registration with the Health Sciences Authority (HSA) in Singapore typically takes 1 to 3 months. The exact time can vary based on factors such as:

  • Completeness of the application: If the required documents are complete and correctly submitted, the process will be faster. Incomplete or incorrect submissions may cause delays as HSA may request additional information.
  • Device complexity: Although D-class devices are considered low-risk, more complex devices may still require a longer review.
  • Workload at HSA: The processing time may also depend on the number of applications being processed by HSA at any given time.

Once the application is submitted, HSA will review the technical documentation, risk management plans, and other relevant information to ensure the device meets regulatory requirements. If there are no issues with the application, approval is generally granted within the 1-3 month timeframe.

louis-reed-pwcKF7L4-no-unsplash(2).jpg

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn


Last one: What are the benefits of applying for D-class medical device registration in Singapore HSA?
The next one: What does D-class medical device registration in Singapore HSA mean?
return