Singapore Medical Device Registration

Understanding HSA’s Medical Device Registration and Vigilant System

Update On: 24/01/2024 

Regulatory Authority: Medical Device Branch of the Health Sciences Authority (HSA)

The Medical Device Branch of Singapore’s Health Sciences Authority (HSA) is in charge of overseeing medical device regulation. The Health Product Act was approved in 2007 by the HSA, giving them the authority to impose mandatory registration requirements, control supply distribution, manufacture, import, and advertising of all health goods.

Medical Device Definition: They are defined as health products which have a physical and mechanical effect when used on human bodies and are used to: diagnose, treat a medical condition, e.g. X-Ray Machine; Measures or monitors the function of the body e.g. Pulse oximeter;

Products which are used to maintain or support well-being, such as body toning equipment, magnetic accessories and massagers, are not medical devices and hence are not regulated by HAS.  

Link for Regulatory Authority: https://www.hsa.gov.sg/

Local Regulation: Health Products Act 2007 and Health Products (Medical Devices) Regulations 2010

Medical Device Classification: A, B, C, D

Listing or Registration: Requirements:

• Registration is not required for Class A devices. All Class A devices must be listed in the HSA’s Class A Medical Device Register by the local manufacturer or local importer.

For systems, product families or other multi-component devices, determine most favourable grouping strategy according to HSA Guidance GN-12.

• Foreign medical device manufacturers must appoint a Singapore-based Registrant to submit their application and represent them to the HSA, with registrations transferable only if the current Registrant relinquishes.
• For classes B, C and D, if device has been approved for sale in one or more reference markets (Australia, Canada, the Europe, Japan or the USA), it qualifies for an Immediate, Expedited, or Abridged submission process*.
• Prepare Submission Dossier using ASEAN Common Submission Dossier Template (CSDT) format or IMDRF Table of Contents (ToC) format. Provide proof of compliance with reference market’s QMS requirements. Abridged/Expedited submission: Summary data can be submitted for pre-clinical and clinical data. Additional details for Classes B, C, and D may be found in HSA Guidance GN-15.
• Registrant submits application electronically via the Medical Device Information and Communication System (MEDICS). Pay fee.
• Appoint a registered importer to bring device into Singapore.
• For Classes B, C, and D devices, HSA verifies classification and performs detailed evaluation of your application.
• HSA grants approval and publishes in the Singapore Medical Device Register (SMDR).
• Can now begin market device in Singapore. Registrations do not expire but must pay fees annually to maintain registrations.

* Full Evaluation Route refers to the evaluation process for a medical device that has not received any prior approval from any regulatory agencies. Abridged Evaluation Route refers to a medical device that has received approval from reference regulatory agencies, such as TGA, HC, MHLW, FDA, or EC Certificates. The Immediate/Expedited Evaluation Route allows medical devices to be evaluated if they have received at least one approval, been marketed for at least three years, have no global safety issues, and have no prior rejections. The Priority Review Scheme offers faster registration and market entry for devices in five healthcare areas. 

Document Requirements for registration:

The information required in submissions depends on device class and selected evaluation route.

For the most part, documentation from an EU technical file can be used to satisfy many supporting documentation requirements. One must also prepare a Declaration of Conformity to the Essential Principles. Once approved, product is listed in the Singapore Medical Device Register (SMDR) database.

Registration timeline: 1-10 Months

Registration Fee: 25,00$ – 5.700,00$

License Validity: Unrestricted Validity but fee must be paid annually

License Renewal: The license will be automatically renewed for another year after the annual renewal fee is paid

Turnaround Time (In working days):

Language Requirements: Documentation and labelling must be provided in English.

Adverse events reporting of medical devices

Any adverse event (AE), which meets the three basic reporting criteria listed below, is considered as a reportable adverse event:

• An AE (or potential AE) has occurred.
• The medical device is associated with the AE.
• The AE leads to one of the following outcomes:
  • It becomes a serious threat to public health.
  • The death of a patient, user or other person.
  • Serious deterioration in state of health of patient, user or other person.
  • There is no death or serious injury in the initial AE, but it might lead to death or serious injury of a patient, user or other person if the AE recurs.

The initial report of an adverse event should contain as much detail as possible and should not be delayed for the sake of gathering more information. If more than one dealer is involved in a reportable AE, each one must submit their own report.

It is mandatory for medical device companies, including product registrants, manufacturers, importers and suppliers, to report any AEs related to the medical devices they deal in.

The following medical device-associated AEs must be reported to us:

Dealers of medical devices are to follow up with a final report within 30 days of the initial report, detailing the investigation into the adverse event. Follow-up reports may be requested as and when necessary.

Submit the Mandatory Medical Device Adverse Event Reporting Form for Medical Device Dealers through e-mail.

What is FSCA?

A FSCA is any action taken to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device. It is required when it becomes necessary for the medical device product owner to take action to eliminate, or reduce the risk of, the identified hazards.

A FSCA includes:

• The return of the medical device to the product owner.
• Replacement or destruction of the medical device.
• Any action regarding the use of the medical device that is taken in accordance with the advice of its product owner.
• Permanent or temporary changes made to the labelling or instructions for use of the medical device.
• The clinical management of any patient who has used the medical device.
• Modification of the medical device.
• Retrofitting the medical device in accordance with any modification to it or any change to its design by its product owner.
• Upgrading any software used with the medical device, including any such upgrade carried out by remote access.

You need to report a FSCA if the affected device meets any of the following criteria:

• The medical device has been manufactured, imported or supplied in Singapore
• The medical device has been registered or given special authorisation for local supply 

Who to report?

The reporting person should be the dealer that manufactured, imported, supplied or the product registrant for the affected devices. In cases where more than one dealer is involved, they may be required to make individual reports.

Reporting procedure

• Before initiating a FSCA, the dealer has to notify HSA. In cases where more than one dealer is involved, each dealer will need to report the FSCA individually.
• Once reported to HSA, the dealer can proceed to initiate it without waiting for approval from HSA.
• Medical device dealers should report the Field Safety Corrective Action via the newly launched Online Safety, Compliance Application and Registration (OSCAR) System

Who should make this communication:

• Manufacturer
• Authorized Representative

When to make this communication: Before placing a medical device into the market.

How OMC Medical can assist you with the process:

Why Choose Us

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk