Medical Device Registration and Approval in Singapore

General country-specific regulatory information is provided on this page for medical device registration and approval in Singapore. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including Singapore, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in Singapore

 

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 incorporate medicinal products

Abridged Route: 220 working days

Full Route: 310 working days

SPECIAL REQUIREMENTS: Not applicable for Local Tests/Permits, Clinical Evaluation or Studies

LOCAL FEES (New Application):

MD/IVDs Class A

MD/IVDs Class A are exempt from product registration.

MD/IVDs Class B

Immediate Route: US$ 680

Abridged Route: US$ 1,350

Full Route: US$ 2,650

Priority Review Scheme 1: US$ 3,010

Priority Review Scheme 2:  US$ 3,900

MD/IVDs Class C

Immediate & Expedited Route: US$ 2,270

Abridged Route: US$ 2,650

Full Route: US$ 4,310

Priority Review Scheme 1: US$ 4,850

Priority Review Scheme 2: US$ 6,315

MD/IVDs Class D

Expedited Route: US$ 4,085

Abridged Route: US$ 4,315

Full Route: US$ 8,520

Priority Review Scheme 1: US$ 9,700

Priority Review Scheme 2: US$ 12,560

MD Class D – which incorporate medicinal products

Abridged Route: US$ 7,500

Full Route: US$ 55,220

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 the 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 agencies (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:

1. Has obtained at least one approval (two for Class D) from reference regulatory agencies
2. Has been marketed for at least 3 years under the reference regulatory agencies jurisdiction
3. Has no safety issues globally in the last 3 years
4. 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 have 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.

Last updated on October 27, 2020.

Other Southeast Asian Countries:

Cambodia, Indonesia, Malaysia, Myanmar, Philippines, Thailand, Vietnam