Medical Device Registration in Singapore
Your Market Entry into Southeast Asia Most Trusted Healthcare Market - Singapore
At Andaman Medical, we manage the full medical device registration process in Singapore from start to finish with clear, practical guidance at every stage. From understanding the requirements of the Health Sciences Authority to managing submissions through the Singapore Health Product Access and Regulatory E-System, we ensure your products achieve full regulatory compliance and a smooth, efficient market entry so you can stay focused on delivering high-quality medical technologies.
Why Register Your IVDs or Medical Devices in Singapore?
- Enter one of Southeast Asia’s most advanced and internationally recognized healthcare markets
- Strengthen your regional market entry strategy through Singapore’s role as a regulatory and commercial hub
- Navigate HSA regulatory requirements with expert local guidance
- Maintain long-term regulatory compliance and continuous product availability
Partner with Andaman Medical for seamless medical device registration in Singapore. We manage the regulatory process so you can focus on delivering high-quality healthcare solutions.
Access to a Growing Market
Access to a Growing Market
Singapore is renowned for its advanced healthcare system and cutting-edge medical technologies. Registering your medical device in Singapore means gaining access to a market that values innovation and has the purchasing power to invest in high-quality diagnostic tools.
Stringent Regulatory Standards
Stringent Regulatory Standards
Singapore’s regulatory standards are among the highest in the world. The HSA adheres to stringent regulations that align closely with international best practices. This ensures that your product meets global quality and safety standards, which can be a significant selling point when marketing your device locally and internationally.
Potential for Faster Market Entry in Southeast Asia
Potential for Faster Market Entry in Southeast Asia
Singapore’s strategic location and its status as a leading business hub in Southeast Asia make it an excellent starting point for regional market expansion. Successful registration in Singapore can expedite the approval process in other Southeast Asian countries.
Well-Established Healthcare Infrastructure
Well-Established Healthcare Infrastructure
Singapore’s healthcare infrastructure continually evolves to incorporate the latest advancements in medical technology. This environment provides a seamless platform for clinical validation and real-world testing.
Who Can Register a Medical Device in Singapore?
Only companies registered locally in Singapore with the Accounting and Corporate Regulatory Authority (ACRA) can apply for a dealer licence and register a medical device. After registering with ACRA, a company must create a Client Registration and Identification Service (CRIS) company account with the HSA. This account allows companies to access the SHARE portal and conduct electronic transactions such as product registrations.
Create CRIS Account
After ACRA registration, create a CRIS company account with the HSA.
Apply for Dealer Licence
Apply for a dealer licence based on your activity: Manufacturer’s Licence, Importer’s License, or Wholesaler’s License (import and export).
Obtain Registrant Account
Only companies with a Registrant Account can register a medical device in Singapore.
Options for Foreign Manufacturers
Set Up a Legal Subsidiary
Establish a subsidiary to register the medical device.
Appoint a Local Importer or Distributor
Choose a local importer or wholesaler with a valid dealer’s licence, Good Distribution Practice for Medical Devices (GDPMDS) certification, and a Registrant Account to register the devices via SHARE.
Appoint an Authorised Representative (AR)
Use a company like Andaman Medical, which has a valid Registrant Account, to register the medical devices on your behalf. This allows you to appoint multiple importers or wholesalers without affecting the product licence.
Who can register a medical device in Singapore?
Only companies registered locally in Singapore with the Accounting and Corporate Regulatory Authority (ACRA) may apply to obtain a dealer license and register a medical device. Once registered with ACRA, a company must create a Client Registration and Identification Service (CRIS) company account with the HSA; this allows companies to access the online MEDICS portal and conduct electronic transactions such as product registrations with the HSA.
Once the CRIS account is ready, a company can apply simultaneously for a dealer license according to their activity: Manufacturer’s License, Importer’s License or Wholesaler’s License (import and export) as well as a Registrant Account. Only companies which have a Registrant Account can register a medical device in Singapore.
As only local (Singaporean) companies can apply for a Registrant Account, foreign manufacturers, therefore, have three (3) possibilities to register their medical device in Singapore:
Set up a legal subsidiary entity
to register the medical device
Appoint a local importer or wholesaler
who has a valid dealer’s license, Good Distribution Practice for Medical Devices (GDPMDS) certification and a Registrant Account in Singapore to register the medical devices via MEDICS
Appoint an independent third party
such as Andaman Medical to register the medical devices. Andaman Medical has a valid Registrant Account and acts directly on behalf of foreign manufacturers. We register and maintain your device license which also means you have the freedom to appoint as many importers or wholesalers for your device as you require while the product license will not be affected by any changes in the distributor network
What is considered a medical device in Singapore?
As set out in the Health Products Act 2007, a ‘medical device’ —
a) means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article that is intended by its manufacturer to be used, whether alone or in combination, for humans for one or more of the specific purpose(s) of:
i) diagnosis, prevention, monitoring, treatment or alleviation of any disease;
ii) diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury;
iii) investigation, replacement, modification or support of the anatomy or of a physiological process, mainly for medical purposes;
iv) supporting or sustaining life;
v) control of conception;
vi) disinfection of medical devices; or
vii) providing information by means of in vitro examination of specimens derived from the human body, for medical or diagnostic purposes,
and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means, and which is not a cell, tissue or gene therapy product;
and
b) includes the following articles:
i) any implant for the modification or fixation of any body part;
ii) any injectable dermal filler or mucous membrane filler;
iii) any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means.
Please note: in this webpage we will use the term medical devices to include medical devices as well as in-vitro diagnostics.
Why Choose Andaman Medical?
