Procedures and processes for importing medical equipment into the Singapore market in 2025

Nowadays, medical and healthcare is one of the most developed and successful industries in Singapore. The number of healthcare facilities is increasing, and companies in this field are also starting to improve the standards of medical equipment and instruments by importing equipment from countries with advanced technology in the world. However, the import of medical equipment in Singapore is very strictly regulated and rigorous by Health Sciences Authority (“HSA”) to ensure the best quality of service in the global market. 

The following article by GLA will provide Businesses set up company in singapore Basic information on the requirements and regulations for importing medical devices in Singapore. 

To import medical equipment into the Singapore market, businesses need to perform two main tasks:

• Register medical devices with the Singapore Health Sciences Authority.
• Apply for import license. 

1. Definition of medical device under the Singapore Healthcare Act (HPA) in Singapore

Medical Device includes instruments, apparatus, equipment, machines, implants, in vitro reagents and calibrators, software, materials or other similar or related items used to perform tasks in the medical field. Tasks such as diagnosis, prevention or treatment but not related to pharmacological, immunological or metabolic measures.”

The HPA (Health Products Act) classifies medical devices into four categories depending on the level of risk assessed based on factors including duration of use, invasiveness into the human body or implantation under the skin, involvement of drugs or biological compounds, etc.

Since August 8, according to Singapore Health Products Act (“HPA”), all medical devices including those licensed under the Radiation Protection Act, must be registered with Health Sciences Authority (“HSA”) prior to supply, unless such devices are used for clinical trials, are custom-made, and/or are Class A devices on an exemption list. Some (low-risk) medical devices pose a risk only when used and are therefore exempt from product registration. However, exemption from product registration does not relieve the marketer of such devices of their responsibilities under the Law and Regulations. 

From 1 January 1: All medical devices regardless of their level of danger (except products exempted from registration), for import and supply must meet one of the following criteria:

• Listed on the Singapore Register of Medical Devices (Singapore Medical Device Register (“SMDR”));
• Listed on the Forwarding List; OR
• Authorized through one of the licensed routes. 

For medical devices imported solely for re-export or manufactured solely for export, such import and export must be notified to the Regulatory Authority.

2. Registration requirements for each type of medical device

The Singapore Healthcare Act (HPA) requires product owners and product registrants to register their products with the Ministry of Health of Singapore (HSA) for listing in the Singapore Medical Device Register (SMDR). Listing in the SDMR must occur before the device is supplied to the domestic market. The product registration requirement will only apply to sterile Class A, Class B, Class C and Class D medical devices to be supplied to the domestic market.

A Singapore incorporated company that is registered with the Accounting and Corporate Regulatory Authority (ACRA) can apply for product registration. It can be a Singapore subsidiary of the product owner (the principal manufacturer) or a local company authorized by the product owner to apply for product registration.

The product owner must document the purpose of the device and determine the risk class of the device in accordance with the classification rules in the HSA Regulatory Guidance. Where a particular device is identified as having more than one risk class, the highest risk class must be considered.

2.1 Registration of medical devices type A

Registration of Class A Medical Device does not require filing an application in the CSDT form. (ASEAN Common Submission Dossier Template). The application process is quite simple, consisting of four steps – application, screening, assessment and regulatory decision by the Authority. The application must be accompanied by:

• Original labels and packaging in English.
• User manual.
• Patient information leaflet (if available).
• Advertising materials.
• Sterility validation report (if available).
• Medical device measurement certificate (if any).
• Electrical safety standard certificate (if any).

2.2 Registration type B, C, D

The product registration application must be prepared in accordance with the CSDT Form in English and must be accompanied by all relevant certificates, reports and labels etc., as annexures. The level of detail required will vary depending on the assessment route chosen by the owner/registrant.

Pre-application advice may be necessary if there are specific issues or where there is uncertainty as to whether an application meets the applicable requirements.

3. Procedures for registering medical devices imported into Singapore

4. Application process for Medical Device Registration through MEDICS in Singapore

5. License to import medical equipment into Singapore

A company importing medical devices into Singapore is required to obtain an importer's permit. The application for an Importer's Permit will be submitted via the online system, MEDICS@HSA.

The Company will appoint a key contact person who will liaise with the Authority on all matters relating to applications submitted by the Company, including requests for input into applications.

The application must be accompanied by a certificate of Distribution Practice for medical devices in Singapore (Good Distribution Practice for Medical Devices in Singapore (“GDPMDS”)) or ISO 13485 certification, including scope of storage, distribution and a list of exempted imported Class A medical devices.

For companies that do not manufacture or import exempted Class A medical devices, the company must provide a company paper declaration. GDPMDS certification is carried out by certification bodies accredited by the Singapore Accreditation Council.

Good Distribution Practice for Medical Devices in Singapore (GDPMDS) certification is not required for the following activities:

• Import for re-export only.
• Import for non-clinical use only.

In the above exceptional cases, a declaration must be submitted in lieu of a certificate.

Each licensee must notify the Authority when any details previously declared are changed.

The license is valid for 12 months, a license renewal reminder email will be sent from the Authority to license holders 60 days before the license expires. Renewal applications must be submitted 40 days before the license expires.

Note: Companies that only carry out medical equipment transshipment activities, within the airspace or seaports of the Free Trade Zone (FTZ), do not require a license from the HSA.

Importing medical devices into zero-rated GST warehouses will require a medical device importer license. When exporting (which is a wholesale supply) these medical devices, a medical device wholesaler license is required.

Obligations of importers

Importers must fulfill the following mandatory obligations:

• Maintain import and supply records.
• Maintain records of complaints.
• Report any deficiencies and adverse effects to HSA.
• Notify HAS of actions taken by the manufacturer to reduce the risk of death or serious impairment of health associated with the use of a marketed medical device (field safety correction actions).
• Prohibit false or misleading advertising.

6. How does GLA support Singaporean businesses to register and import medical devices into Singapore?

GLA, a unit with many years of experience supporting Singaporean businesses to register and import medical equipment into the Singapore market, supports businesses:

• Establishment of Singapore company for medical equipment business full package, from AZ. 
• Guide businesses to prepare documents and determine the risk level of medical devices in Singapore.
• Business representative to register medical devices in Singapore.
• Support for operating Singapore businesses after establishment includes regulations on: Singapore corporate tax accounting, financial statements, GST registration, etc.

7. Frequently asked questions when registering and importing medical devices into Singapore

Highlights

• Importing medical devices in Singapore requires medical device registration with the Singapore Ministry of Health (HSA).
• Create a CRIS account through MEDICS to proceed with medical device registration with HSA.
• Obtaining an import license into Singapore is a mandatory requirement for companies importing medical devices into Singapore.