Medical Device Registration in Singapore
Singapore’s healthcare market is highly regulated and offers valuable opportunities for medical device companies. However, navigating the registration process can be complex. That’s where Andaman Medical steps in.
With our deep expertise in medical device registration in Singapore, we streamline the process and offer practical guidance at every stage. From understanding the Health Sciences Authority (HSA) requirements to submitting transactions through the Singapore Health Product Access and Regulatory E-System (SHARE), we ensure full compliance with local regulations.
Medical device registration in Singapore
All medical devices whether manufactured domestically or imported, must be registered with the Health Science Authority (HSA) before they can be supplied in Singapore, except for Class A low-risk medical devices, which are exempted from product registration. All product registration transactions including any future renewals or change notifications are conducted online through the Medical Device Information and Communication System (MEDICS).
Why Register Medical Devices in Singapore
Registering your IVD or medical device in Singapore goes beyond meeting regulatory requirements. It grants access to one of Southeast Asia’s most advanced and trusted healthcare markets, known for its high standards and growing demand for quality medical technologies.
At Andaman Medical, we provide comprehensive regulatory support to help you navigate Singapore’s medical device registration process with clarity and confidence.
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.
Why Choose Andaman Medical as Your Medical Device Registration Consultant in Singapore?
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.
