Government Authority

Medical device product registration in Singapore is overseen by the Health Sciences Authority (HSA), before being imported and placed on the market.  When applying for product registration in Singapore, applications must be submitted by a local entity that also acts as license holder, or Registrant. The Singapore-based entity must be registered with the Accounting and Corporate Regulatory Authority (ACRA) of Singapore. Medical device registration processing is conducted through the HSA online Medical Device Information and Communication System (MEDICS). Successful applications will generate a registration certificate and a listing on the Singapore Medical Device Register (SMDR). 

Medical Device Status

In Singapore, a medical device is any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of  diagnosis, prevention, monitoring, treatment or alleviation of disease or injury. 

Product Classification

The HSA closely follows GHTF guidelines for medical device classification with Class A, B, C and D devices ranging from low to high risk. In Singapore, there are four different registration pathways. Class B, C and D devices that are registered in one reference country are eligible to apply for the Abridged registration. Devices without reference country approvals are subject to the Full registration process.

Requirements for the different registration pathways:

Class C devices that are Standalone medical mobile applications qualify for an Immediate Registration (ICR): with 1 Reference country, no safety issues globally and no prior rejection in Singapore

Class C devices excluded from the Expedited registration (ECR):

• Hip, knee and shoulder joint replacement
• Non-bio-active implants. 

Class D devices excluded from the Expedited registration (EDR):

• Active Implantable devices
• Implantable devices connected circulatory system or central nervous system
• Hip, knee, and shoulder joint replacement (bio-active implants)
• Devices incorporating a registrable drug in an ancillary role
• IVD devices for HIV
• Blood/tissue donor compatibility

Cost and time for regulatory review will vary considerably with device classification and reference country registrations.

In addition to the application processing fee, the HSA also charges a one-time application fee of S$500 for all classifications of devices.  There is also an annual listing fee of S$35, S$60 and S$120 for Class B, C and D devices respectively.

Device Conformity Assessment

Class A devices do not require pre-market registration, but must be listed with the HSA on an annual basis by the licensed importer.  

The HSA submission dossier  is based on the ASEAN CSDT (Common Submission Dossier Format). The required information varies based on the device classification and available registration route. In addition to documents required by the EU technical file, applications require a Declaration of Conformity to the Essential Principles.

Quality Systems Conformity Assessment

Quality systems conformity assessment must be documented with ISO 13485 or an audit report from the FDA (e.g., Establishment Inspection Report) or Japanese PMDA.

Regulatory Efficiency

The Singapore medical device registration process is considered highly transparent and predictable.

Reference Country Approval Requirement

Reference Country Approvals can significantly influence the registration pathway of Class B, C and D devices. The following countries are acceptable Reference Countries.

Validity and Renewal

As long as annual listing fees are maintained, and post market vigilance requirements are met, registrations do not expire.

License Holder Requirements

A local agent or registrant needs to submit the registration application and hold the license. Additionally, a Licensed Importer is needed for Customs clearance. The Licensed Importer requires an ISO 13485 and/or Good Distribution Practice Medical Device – Singapore (GDPMD-S) license and must to be registered with the HSA. 

License Transfer

Medical device registration applications must be submitted by a local entity that also acts as license holder, or Registrant. The Registrant is the key point of contact for the Health Sciences Authority (HSA) regarding the device listing.

The Health Products Act provides for the transfer of Registrant related to an active listing.  Guidance is provided in GN-24, Guidance on the Change of Registrant.

The Change of Registrant Application is processed by the HSA in 40 days at a fee of S$820 (US$595).  One application may cover multiple medical device licenses (from one relinquishing Registrant to a single accepting Registrant).  The annual listing fee is not affected by a Registrant change. The next payment date will remain the anniversary date of the listing.

Responsibility for devices imported under the relinquishing Registrant may be retained by the relinquishing Registrant or transferred to the new Registrant. The transfer process requires a Relinquishing Company Declaration Form executed by the incumbent Registrant among other documents.

Benefits of Independent License Holding through Asia Actual

• Sell directly to multiple regional distributors, avoiding mark-up by a national importer
• Increase transfer pricing 
• Improve leverage in distributor negotiations/responses
• Add or change distributors as required
• Keep intellectual property away from local commercial agents
• Assure expert handling of  post market vigilance and license maintenance

Contact Asia Actual for assistance to confirm the cost and time lines that apply to your medical devices. Asia Actual has experienced, top level consultants in Singapore to manage the application process.