REGULATORY AUTHORITY:
Health Sciences Authority (HSA)
CLASSIFICATION SYSTEM:
Medical Devices/IVD: A/B/C/D
TIMEFRAME:
MD/IVDs Class A
MD/IVDs Class A are exempted from product registration
MD/IVDs Class B
Immediate Route: immediate registration upon submission
Abridged Route: 100 working days
Full Route: 160 working days
Priority Review Scheme: 120 working days
MD/IVDs Class C
Immediate Route: immediate registration upon submission (for Class C standalone medical mobile application only)
Expedited Route: 120 working days
Abridged Route: 160 working days
Full Route: 220 working days
Priority Review Scheme: 165 working days
MD/IVDs Class D
Expedited Route: 180 working days
Abridged Route: 220 working days
Full Route: 310 working days
Priority Review Scheme: 235 working days
MD Class D – which incorporating medicinal products
Abridged Route: 220 working days
Full Route: 310 working days
SPECIAL REQUIREMENTS:
Local test or clinical study is not required.
LOCAL FEES (New Application):
MD/IVDs Class A
MD/IVDs Class A are exempted from product registration.
MD/IVDs Class B
Immediate Route: US$ 748
Abridged Route: US$ 1505
Full Route: US$ 2916
Priority Review Scheme 1: US$ 3304
Priority Review Scheme 2: US$ 4231
MD/IVDs Class C
Immediate & Expedited Route: US$ 2497
Abridged Route: US$ 2916
Full Route: US$ 4680
Priority Review Scheme 1: US$ 5234
Priority Review Scheme 2: US$ 6720
MD/IVDs Class D
Expedited Route: US$ 4432
Abridged Route: US$ 4680
Full Route: US$ 8968
Priority Review Scheme 1: US$ 10169
Priority Review Scheme 2: US$ 13074
MD Class D – which incorporating medicinal products
Abridged Route: US$ 7922
Full Route: US$ 56499
LOCAL FEES (Manufacturer):
Local manufacturer, importer, and wholesaler must register their establishment if they wish to have activities related to medical devices. The importer and the wholesaler of medical devices must apply for Good Distribution Practices of Medical Devices (GDPMD) certification (other than Class A devices).
LICENSE VALIDITY:
1 year – the license will be automatically renewed for another year after annual renewal fee is paid.
LICENSE TRANSFER:
License transfer process is possible in Singapore, the process is called “Change of Registrant”.
AUTHORIZED REPRESENTATIVE:
A local authorized representative should be appointed. This authorized representative will also become the license holder.
ADDITIONAL INFORMATION:
Full Evaluation Route – Evaluation route for a medical device that has not obtained any prior approval from any of reference regulatory agencies.
Abridged Evaluation Route – Evaluation route for a medical device that has obtained at least one approval from reference regulatory agency (TGA – Australia, HC – Canada, MHLW – Japan, FDA – United States, EC Certificates – EU Notified Bodies)
Immediate/Expedited Evaluation Route – Evaluation route for a medical device that:
•Has obtained at least one approval (two for Class D) from reference regulatory agencies
•Has been marketed for at least 3 years under the reference regulatory agencies jurisdiction
•Has no safety issues globally in the last 3 years
•Has no prior rejection/withdrawal from reference regulatory agencies
Priority Review Scheme – The Priority Review Scheme provides the option for applicants to gain faster registration and market entry for their medical devices that are submitted to HSA through the Full evaluation route. This priority review is eligible only for medical devices which has intended use that focus on the following five healthcare areas: cancer, diabetes, ophthalmic, cardiovascular, and infectious disease. It is also applicable for medical devices which is intended for an unmet clinical need.
Other Southeast Asian Countries: Cambodia, Indonesia, Malaysia, Myanmar, Philippines, Thailand, Vietnam
Last Update: January 2023
