Medicines and Medical Equipment
The medical equipment industry is a great investment for both local and foreign companies. Expanding this business overseas helps reach more customers and partners around the world. But choosing the right country to set up your company—with good tax benefits, legal support, and simple procedures—can be confusing.
Not only a financial center, Singapore is also a leading center for manufacturing, research, development and commercial activities in the Asian region in particular and the world in general. In particular, the pharmaceutical industry, medical equipment, medical supplies and raw materials for the production of medical equipment are one of the strong pillars in the Singapore economy, with many globally famous drugs and important medical supplies produced here.
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:
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.
| Species | Level of risk | For example |
| A | Low risk | Surgical aids/tongue depressors |
| B | Low to medium risk | Syringe |
| C | Medium high risk | Ventilator/bone fixation splint |
| D | High risk | Artificial heart valve/Defibrillator |
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:
For medical devices imported solely for re-export or manufactured solely for export, such import and export must be notified to the Regulatory Authority.
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.
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:
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.
Singaporean companies conduct medical device risk assessment and classification through questions at Singapore Ministry of Health (HSA) website.
Depending on the risk level of each type of device (A/B/C/D), there will be different medical device registration requirements.
After determining the level of risk of the medical device, the Enterprise will prepare the medical device registration dossier according to the level of risk, details mentioned in the section. 2. Registration requirements for each type of medical device
Singaporean businesses registering medical devices in Singapore are required to submit a Medical Device Registration application via MEDICS.
To apply for medical device registration through MEDICS, you need:
To meet the conditions for creating a medical device registration account via MEDICS, Enterprises need to complete the procedure. Open a medical device company in Singapore.
Detailed information on the process of submitting medical device registration applications via MEDICS is available in the section 4. Procedure for submitting Medical Device Registration application via MEDICS in Singapore.
Apply for a CRIS Company (Client Registration and Identification Service) account. A CRIS Company account is an account managed by the Singapore corporate Corppass administrator and/or authorized organizations that are eligible to perform account registration. Once the CRIS Company account is successfully created, the administrator can create authorized user accounts to prepare and submit medical device registration applications.
This account allows electronic transactions with HAS.
Once authorised (usually takes 3-4 working days), through CRIS, company employees or service providers can then access MEDICS using their SingPass or HSA PIN.
Once you have a CRIS account, apply for a Registrant's Account. This account allows companies to register medical devices on behalf of product owners. Only registered Singapore companies are allowed to have a Registrant's Account and the process is processed within 7 working days.
At this step, Singaporean Enterprises need to register medical devices according to the risk level (A/B, C, D) to prepare appropriate registration documents in accordance with HSA regulations. Details of medical device registration documents according to the risk level are listed in detail in the section. 2. Registration requirements for each type of medical device
The application will be reviewed to ensure that the required information and documentation are complete. If the application is incomplete, the applicant will be sent a request to resubmit the missing information or documentation. If the applicant fails to provide all the required information, or the information submitted is incomplete, or contains information that is not required, the application will be rejected. Similarly, applications that are not made in the prescribed form, product applications for non-medical devices, or applications for inappropriate product types and evaluations will also be rejected.
The examination will start after the fee is paid. If a product has been examined and placed on the market in at least one of the founding member countries GHTF (Global Harmonization Task Force), the validation process can be shortened. All other Class B, C and D medical devices must undergo a full validation process.
The applicant may be asked for additional information at this stage and this must be submitted within 14 days. Where the requested information cannot be provided within the stipulated time, the applicant may request the Authority for additional time. If the applicant fails to provide the requested details within the agreed timeframe, the application will be refused.
During the assessment process, if the Registrar determines that a product is “registrable”, the registrant may apply to list the device on the Singapore Medical Device Register (SMDR). The registrant must comply with all the Registrar’s conditions for registration.
Products are registered electronically, so there will be no hard copy certificates. If the registrant wants a hard copy registration certificate, the registrant must pay a fee to request a hard copy certificate. An annual fee will be charged to retain the products registered in SMDR.
The time it takes to register a product after filing depends on the type of product and the type of review. For Type A products, it is 60 working days, while for Type B, C and D products, it takes about 100-310 working days.
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:
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:
GLA, a unit with many years of experience supporting Singaporean businesses to register and import medical equipment into the Singapore market, supports businesses:
1. Is it mandatory for a business to set up a company in Singapore to import medical equipment into Singapore?
Businesses importing medical devices into Singapore are required to register their medical devices with the Singapore Ministry of Health (HSA) and need a SingPass or HSA PIN to register an account through MEDICS. Therefore, businesses need to set up a company in Singapore to import medical devices.
2. Which businesses need to register medical devices with the Singapore Ministry of Health (HSA)?
All businesses importing medical devices into Singapore are required to register their medical devices with the Ministry of Health in Singapore (HSA) unless the devices are used for clinical trials, are custom-made, and/or are Class A devices on the exemption list.
3. Where can I find guidance on applying for a Distribution Practice Certificate for medical devices in Singapore?
Singapore businesses can learn about the Certificate of Distribution Practice for medical devices in Singapore at the following HSA link: Good Distribution Practice for Medical Devices.
Highlights
Businesses in need Expanding pharmaceutical business to the Singapore market , Asia's leading prestigious pharmaceutical center, the first step that cannot be skipped is to register for a license to import and distribute drugs at the Singapore Health Sciences Authority (HSA).
Although it sounds simple, in reality this process requires businesses to meet many strict standards from:
Even a small error in the application can cause the approval process to be delayed or denied.
In this article, GLA will guide businesses in detail on the process of registering for a license to import and distribute drugs in Singapore according to regulations in 2025, helping businesses save time, reduce legal risks and effectively deploy pharmaceutical activities in Singapore.
Singapore is one of the most developed and regulated pharmaceutical markets in Asia. With a world-class healthcare ecosystem, it is not only pharmaceutical distribution center of the region, Singapore is also “gateway” to the ASEAN market for foreign businesses.
The Singapore Government prioritizes the development of the biopharmaceutical and pharmaceutical manufacturing industry as a key sector, attracting international investment and promoting research and development (R&D) activities.
To support businesses, Singapore has invested in building specialized infrastructure for the pharmaceutical industry, typically Tuas Biomedical Park, helping businesses quickly establish and deploy pharmaceutical production activities that meet international standards.
Any import, distribution or trading of drugs in Singapore is license required HSA-issued certification, to ensure quality, safety and increased transparency throughout the supply chain.
Benefits when Enterprises own a license to import and distribute drugs from HSA:
The Health Sciences Authority in Singapore is Health Sciences Authority (HSA) under the Singapore Ministry of Health (MOH), responsible for management all import, distribution and production activities pharmaceuticals, medical devices and health products.
Any business that wants to establish a pharmaceutical company in Singapore or import, distribute, or cooperate in pharmaceutical trade in Singapore must HSA authorization required valid.
HSA Official Website
Singapore regulates pharmaceutical activities based on a multi-layered legal framework that includes:
3.1 What is the license to import and distribute drugs in Singapore?
Import and distribution is two completely separate activities, each activity requires a separate license for the drug to be legally circulated in Singapore.
In addition, in the case of businesses trading in medical equipment, the following licenses are required depending on the activity:
3.2 What is GDP certification?
The Good Distribution Practice("GDP")) certification is a certification issued by HSA, Confirm that the business has a system for storing, transporting and distributing drugs that meet safety, quality and traceability standards.
This is voluntary program help businesses comply with international standards for drug distribution and enhance reputation in the supply chain, but no replacement Pharmaceutical Distribution Worker's License (TPWL) to operate legally in Singapore.
Good Distribution Practice Certificate
This certificate is not an import or distribution license, but confirmation The company's distribution system meets national standards, helping drugs reach consumers safely and legally.
3.3 Responsible Person (“RP”) Requirements
Every company with a license to import (TPIL) or distribute (TPWL) drugs in Singapore is required to nominate at least one Responsible Person (RP). RP must be qualified personnel to maintain the quality management system (QMS) according to Good Distribution Practice (GDP) standards.
For products such as prescription or over-the-counter drugs, RP must be a registered pharmacist.
Required conditions of Responsible Person (RP):
To be licensed to import and distribute drugs in Singapore, Enterprises must meet a series of strict conditions set by HSA, to ensure that:
To be carried out safely, transparently and in compliance with international standards, businesses need to meet the following conditions:
To conduct pharmaceutical business in Singapore, businesses need to carry out two main procedures: establishing a company and registering for import and distribution licenses with the Health Sciences Authority (HSA). The basic process includes the following steps:
Businesses must have legal entity in Singapore are eligible to apply for a license to import and distribute drugs.
GLA provides a full range of services Singapore company registration, including legal registration, company address, and business profile.
Documents to be prepared include:
The business has Singapore company registration, can proceed to submit applications for import and distribution licenses for drugs through HSA's official online service portal.
Online application submission helps businesses save time, reduce paperwork and ensure transparent processing of applications.
Once the application for a licence is approved by HSA, the Singapore business will be granted:
This license is legal basis for businesses to officially launch pharmaceutical business operations in Singapore.
After being granted a license, the business is responsible for:
Strict compliance not only helps businesses avoid legal risks, but also strengthens their reputation and sustainable operating capacity in the Singapore market.
The import and distribution license of drugs issued by HSA is valid for 12 months from the date of approval.
Singapore companies need to monitor the license expiration date and apply for renewal. Expired licenses cannot be renewed and new applications need to be submitted.
Businesses can renew their licenses in two ways:
Singaporean companies can apply to cancel their drug import and distribution licenses when no longer conducting business , and no longer needed maintain license.
License cancellation process:
Note to GIRO: Businesses participating in the automatic renewal program through GIRO need to cancel their licenses at least 30 days before the fee deduction date to avoid unwanted renewal fees.
During the application process for a license to import and distribute drugs in Singapore, HSA often reject or return the application If you find the following common errors:
Incomplete or incorrectly formatted records on the Pharmaceutical Regulatory Information System (Pregulatory Information System).
The common mistake is missing documents obligatory, incorrect information, or file/document is not in the correct format that HSA requires.
When this happens, HSA cannot fully review the application and will reject it or return it for correction.
A newly established pharmaceutical company, applying for a license to import drugs into Singapore, entered the wrong drug name in PRISM, resulting in the application being rejected by HSA, and the company had to supplement and resubmit all documents.
The Responsible Person (RP) does not meet the standards
HSA requires RP to be a person have professional competence , and practical experience, responsible for ensuring quality, safety and regulatory compliance throughout the supply chain, businesses may encounter situations including:
Lack of GDP certification or substandard storage facilities
One of the common errors that causes HSA to refuse to issue a distribution permit (TPWL) is that the business no certification provided Good Distribution Practice (GDP) valid or the warehouse facility does not meet the standard.
HSA requires proof that businesses have a system for storing, transporting and distributing medicines that meets safety standards, ensures quality and has full traceability.
Real life example: A client at GLA was refused a TPWL licence by HSA due to the storage facility not having adequate temperature and humidity control.
GLA supported the completion of the dossier, guided the adjustment of the warehouse facility according to GDP standards, and finally the TPWL license was successfully approved by HSA.
Unable to prove the legal origin of imported drugs
One of the main reasons why HSA refuses to grant a license to import or distribute drugs is that the business failure to provide complete documentation confirm the legal origin of the drug.
Enterprises must submit invoices, export licenses, and quality certificates from the manufacturer to prove that the drugs are legally produced and exported.
A client at GLA was once refused a TPIL license by HSA because it did not submit a valid invoice and export license for the imported drug.
After receiving support from GLA, the business was guided to standardize all legal documents, complete the application and resubmit. As a result, HSA approved the TPIL license, allowing the business to continue importing legal drugs into Singapore.
GLA accompanies businesses throughout the entire process of establishing and operating a pharmaceutical company in Singapore, helping to minimize legal risks and ensuring that applications are quickly approved by HSA.
1. Can foreign enterprises register for drug import and distribution licenses in Singapore?
Foreign enterprises cannot register for import and distribution licenses for drugs in Singapore on their own.
Only companies that are duly registered in Singapore with ACRA can apply for a license.
If a foreign enterprise does not have a legal entity in Singapore, it is necessary to appoint a local representative (Local Authorized Agent) to act as its representative and carry out procedures with the Singapore Health Sciences Authority (HSA).
GLA supports businesses Open a company in Singapore Full package from consulting, preparing documents and monitoring licenses to ensure transparency and compliance with HSA regulations.
2. Is Good Distribution Practice (GDP) certification required when applying for a license?
Depending on the type of license and scope of activities of importing or distributing drugs:
If a business applies for a pharmaceutical distribution permit (TPWL) for warehousing and wholesale distribution, it is required to comply with GDP standards.
If a business only applies for a drug import license (TPIL) without warehousing or wholesale distribution, GDP is not required from the outset, but HSA may still require a quality management system to demonstrate the safety of the drug.
3. Can one license be used to import or distribute different types of drugs?
Yes, if those products are all within the HSA approved activities scope of the licence.
However, if a business wants to expand into product groups outside its current scope (e.g. prescription drugs, unregistered drugs), it will need to update or supplement its license.
4. If the company or Responsible Person (RP) address changes, do I need to notify HSA?
Businesses must update change information within 14 days of any change in address, facilities, or responsible person (RP).
Failure to update may result in license suspension or revocation.
5. Does HSA conduct periodic inspections of storage facilities?
HSA conducts regular inspections of storage facilities to ensure businesses comply with Good Distribution Practice (GDP) standards and regulations on medicine storage.
Highlights
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