Singapore's strategic position as a commercial hub in Asia presents lucrative opportunities for overseas medical device manufacturers. Class B, C, and D devices must be registered with Singapore's Health Sciences Authority (HSA) before distribution, but authorizations in some other markets can expedite the registration.
Pure Global simplifies the process with AI workflows that accelerate HSA submission preparation, along with local support and representation, all for a flat annual fee.
Singapore’s medical devices market will reach $1.94B by 2029 (8.35% CAGR), while the IVD market grows to $222.5M (5.47% CAGR). Growth is driven by tech advancements, rising chronic diseases, and an aging population (18.4% 65+ in 2022).
Medical devices sold in Singapore are regulated by the Health Sciences Authority (HSA). Pure Global can assist with Singapore's medical device registration and act as your Registrant, ensuring HSA approval to sell in the Singaporean market.
Singapore adopts a risk-based classification system for medical devices, categorizing them into Classes A, B, C, and D. This classification influences the registration requirements and the level of regulatory scrutiny applied.
Manufacturers seeking entry into the Singapore market must:
We provide turnkey regulatory support in Singapore, all for a flat annual fee:
Dossier preparation and submission, powered by AI-assisted workflows and regulatory experts.
In-country representation, with Pure Global serving as your Registrant to the HSA.
Post-market surveillance support, including vigilance reporting and authority communications.
Importer authorizations, post-approval modifications, and renewals.
HSA charges mandatory government fees based on device risk class and evaluation type, with fees assessed per product. Singapore applies a base application fee and, for Class B, C, and D devices, an additional evaluation fee.
An application fee of SGD 560 (approximately USD 435) applies to all classes.
In addition, the following evaluation fees apply:
All fees listed are government fees only and do not include consulting services, dossier preparation, testing, or regulatory representation. Fees may change without notice.
Check our Fee Calculator for up-to-date government fees in 14 markets.
The Health Sciences Authority (HSA) is responsible for regulating medical devices in Singapore. Pure Global can assist with medical device registration in Singapore, ensuring HSA approval to sell in the Singaporean market.
Singapore adopts a risk-based classification system for medical devices, categorizing them into Classes A, B, C, and D. This classification influences the requirements for the Singapore medical device register and the level of regulatory scrutiny applied to each device.
Manufacturers seeking entry into the Singapore market must determine the classification of their products to identify the appropriate regulatory pathway under Singapore medical device regulations. Additionally, they must appoint a Registrant to manage the product registration process with the HSA, fulfilling all duties and obligations under the Health Products Act and regulations.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
Contact us
%201.svg)
