Singapore is the only developed country in Southeast Asia and has the highest GDP per capita in Asia.

Moreover, Singapore is a medical hub in Asia, offering the best healthcare system in the region, which attracts patients from neighboring countries like Malaysia, Brunei, Indonesia, Thailand, and the Philippines, as well as from the Americas, Europe, and the Asia-Pacific.

As a result, medical devices have become a popular category for imports in Singapore. So, how do medical devices enter the Singaporean market? Don’t worry—today, we will explain everything you need to know about importing medical devices into Singapore!

I Health Sciences Authority of Singapore (HSA)

In Singapore, the regulatory authority for medical devices is the Health Sciences Authority (HSA). Established in April 2001 under the Ministry of Health, HSA is responsible for regulating pharmaceuticals, medical devices, health supplements, cosmetics, and more.

HSA developed its regulatory framework for medical devices by referencing systems from countries like the U.S. FDA, EU NB, Canada MDB, Japan MHLW, and Australia TGA, while adapting it to local conditions.

The main legislation includes the Health Products Act 2007 and Health Products (Medical Devices) Regulations 2010. As an ASEAN member, Singapore also follows the ASEAN Medical Devices Directive (AMDD).

For more information, visit HSA's medical devices webpage.

II Product Definition

In Singapore, a "medical device" is defined as any instrument, apparatus, machine, appliance, implant, in vitro reagent, calibrator, software, material, or similar item used alone or in combination for one or more specific purposes for humans.
1 Diagnosis, prevention, monitoring, treatment, or alleviation of disease.
2 Diagnosis, monitoring, treatment, alleviation, or compensation for an injury.
3 Investigation, replacement, modification, or support of anatomy or physiological processes.
4 Supporting or sustaining life.
5 Contraception.
6 Disinfection of medical devices.
7 Providing medical information through in vitro examination of specimens derived from the human body.

III Product Classification

In Singapore, in vitro diagnostic (IVD) products are considered a subset of medical devices (MD). The classification rules for medical devices are based on recommendations from the Global Harmonization Task Force (GHTF).

All medical devices must be registered with the HSA before being supplied in Singapore, except for Class A non-sterile, low-risk devices, which are exempt from registration or can be supplied under specific conditions approved by HSA.

The risk classification of medical devices, including IVDs, is divided into four classes (A, B, C, D), with A being the lowest risk and D the highest.

Specific Classification:

1 General Medical Device Classification in Singapore:

Class A (Low Risk): Surgical retractors, tongue depressors.
Class B (Low-Medium Risk): Hypodermic needles, inhalation devices.
Class C (Medium-High Risk): Lung ventilators, bone fixation plates.
Class D (High Risk): Heart valves, implantable defibrillators.

2 In Vitro Diagnostic Medical Device Classification in Singapore:

Class A: Specimen receptacles.
Class B: Vitamin B12, pregnancy self-tests, urine test strips.
Class C: Blood glucose tests, PSA screening, rubella IgM.
Class D: HIV blood donor screening, HIV diagnostic kits.

IV Product Registration

Singapore adopts an internationally aligned classification system for medical devices, categorizing them into four classes (A, B, C, D) based on their safety risks.

According to the Health Products Act and the Health Products (Medical Devices) Regulations of Singapore, all medical devices, except for exempted products, must be registered with the Health Sciences Authority (HSA) before being allowed for sale in the Singapore market.

An overseas manufacturer without a business location in Singapore must appoint a qualified registrant. The registrant must hold a valid Dealer's Licence from HSA, and all registration procedures will be handled by them.

The registrant or applicant must submit applications online via HSA's Medical Device Information and Communication System. All registered medical devices will be listed in the Singapore Medical Device Register (SMDR), and consumers can check online whether the medical device they are purchasing is registered.

The registration process for Class A medical devices involves four steps: application submission, screening, review, and decision-making by the authority. Non-sterile Class A medical devices are exempt from registration but must meet safety and performance requirements without violating regulations. Sterile Class A devices, including in vitro diagnostic devices, must be registered.

Class B, C, and D devices require application documents in English prepared according to the ASEAN Common Submission Dossier Template (CSDT), including certificates, reports, and labels. If approved in the U.S., Europe, Australia, Japan, or Canada, registration may be expedited.

Additionally, the applicant company must designate a primary contact person responsible for communicating with the relevant authority on all matters related to the application, including providing supplementary materials as requested. After submission and approval of the registration documents, the device will be listed in the Singapore Medical Device Register (SMDR). The applicant must comply with all post-registration conditions and is responsible for subsequent activities.

V Application Process

After determining the evaluation route and risk classification of the medical device, you can refer to the detailed guidelines on the official website for information on the required documents, fees, and processing times for each category.

Class A:

Registration is not required, but information about the exempted Class A product must be provided when applying for a dealer's licence.

Class B:

Full route:

If the product has not been approved by any overseas reference regulatory authority, a comprehensive evaluation by HSA is required.

Abridged route:

If the product has been approved by at least one overseas reference regulatory authority, it can be registered through this simplified evaluation route.

Immediate route:

To be eligible for this application route, the following conditions must be met:

Condition 1
1 Approved by at least one overseas reference regulatory authority.
2 Marketed for at least three years under one of the reference authorities' jurisdictions.
3 No rejection/withdrawal due to quality, performance, or safety issues.
4 No safety issues globally related to the device in the past three years or since its initial launch.

Condition 2
1 Approved by at least two overseas reference regulatory authorities.
2 No rejection/withdrawal due to quality, performance, or safety issues.
3 No safety issues globally related to the device in the past three years.

Class C

Full route

1 If the product has not been approved by any overseas reference regulatory authority, a comprehensive evaluation by HSA is required.

Abridged route

1 If the product has been approved by at least one overseas reference regulatory authority, it can be registered through this simplified evaluation route.

Expedited route

There are two expedited evaluation routes, and the product can be submitted if it meets the requirements of either one.

Expedited Route 1
1 Approved by at least one overseas reference regulatory authority.
2 Marketed for at least three years under the jurisdiction of the approving authority.
3 No safety issues globally related to the device in the past three years.

Expedited Route 2
Approved by at least two overseas reference regulatory authorities.

Immediate route

This route is only applicable to standalone medical mobile applications and must meet the following requirements:
1 It must be a standalone medical mobile application.
2 Approved by at least one overseas reference regulatory authority.
3 No rejection/withdrawal due to quality, performance, or safety issues.
4 No safety issues globally related to the device in the past three years.

Class D

Full route

If the product has not been approved by any overseas reference regulatory authority, a comprehensive evaluation by HSA is required.

Abridged route

If the product has been approved by at least one overseas reference regulatory authority, it can be registered through this simplified evaluation route.

Expedited route

If the medical device has been approved by at least two overseas reference regulatory authorities, it may apply through this route.

This route is not applicable for the registration of the following two types of IVD products: HIV testing (screening and diagnosis).