MEDICAL DEVICE REGISTRATION AND APPROVAL IN Singapore

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
Last update: December 2022

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 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$ 690

Abridged Route: US$ 1380

Full Route: US$ 2680

Priority Review Scheme 1: US$ 3050

Priority Review Scheme 2:  US$ 3950

MD/IVDs Class C

Immediate & Expedited Route: US$ 2300

Abridged Route: US$ 2680

Full Route: US$ 4360

Priority Review Scheme 1: US$ 4900

Priority Review Scheme 2: US$ 6400

MD/IVDs Class D

Expedited Route: US$ 4130

Abridged Route: US$ 4360

Full Route: US$ 8550

Priority Review Scheme 1: US$ 9800

Priority Review Scheme 2: US$ 12700

MD Class D – which incorporating medicinal products

Abridged Route: US$ 7580

Full Route: US$ 55810

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

JUST SAY WHEN!

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