Risk classification of medical devices

Notes:

• The availability of abridged, immediate, or expedited pathways depends on the device’s regulatory history, risk classification, and reference agency approvals.

• Class A medical devices (lowest risk) are generally exempt from product registration but must comply with importer and dealer licensing and post-market requirements.

Guidance on Preparation of a Product Registration Submission for
General Medical Devices using the ASEAN CSDT

Labelling Content Requirements for Medical Devices

Product Owner Information – Name and contact details (address/phone/email).

Device Name – Trade or brand name.

Device Identification – Sufficient details to identify and differentiate the device.

UDI (Unique Device Identifier) – As per UDI guidance (GN-36).

Intended Purpose – User, patient population, and device use (if not obvious).

Batch/Lot/Serial Number – For traceability and recall.

Expiry Date – Safe use-by date (year and month).

Date of Manufacture – If applicable, especially for reusable or non-sterile devices.

Storage/Handling Conditions – Including post-opening storage/shelf life.

IFU Revision Date – Latest revision date and ID number (if applicable).

Package Contents – Description of contents (size, volume, weight, etc.).

Operating Instructions – Special instructions for device use.

Installation/Compatibility Info – If device connects to other devices/software.

Installation Verification & Maintenance – Details on proper setup, maintenance, calibration.

Performance Claims – Intended performance and known side effects.

Specifications – User-relevant specs (e.g., measurement accuracy).

Special Requirements – Special facilities, training, or user qualifications.

Lay User Advice – When to consult healthcare professionals.

Contraindications/Warnings/Precautions – General safety-related instructions.

Critical Warnings – Prominent warnings (e.g., "Caution – Radiation Hazard").

Material Sensitivities – Allergens or sensitizing materials.

Malfunction Protocols – Steps for performance issues or malfunctions.

Interference Risks – From electromagnetic or other sources.

Environmental Exposure Risks – Physical/environmental hazard precautions.

Disposal Instructions – Safe disposal of devices/accessories/consumables: Infection risks, Environmental hazards Physical hazards (e.g., sharps)

Medical device clinical trials are not regulated by us -- they are required to comply with the requirements of the Human Biomedical Research Act. 

List of Revised Fees for Health Products
Revised fees are applicable to applications submitted on and after 1 July 2024

The DOC (see Annex 1) shall be in English and should contain the following
information:-
• an attestation that each medical device that is subject to the declaration
 complies with the applicable Essential Principles for Safety and
Performance, and
 has been classified according to the device classification rules;
• information sufficient to identify the device/s to which the DOC applies;
• the risk class allocated to the device/s after following the guidance found in
Principles of Medical Device Classification;
• the date from which the DOC is valid;
• the name and address of the product owner;
• quality management standards;
• medical device standards (product standards1);
• the name, position and signature of the responsible person who has been
authorised to complete the DOC upon the product owner’s behalf.

Foreign regulatory authorities may require Free Sale Certificates to fulfil import requirements in their jurisdictions. Local medical device dealers may voluntarily apply for Certificates issued by HSA. 

A Free Sale Certificate (FSC) can be issued to registrant companies requiring the certificate for medical devices that are registered on the SMDR.

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.

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.
FSCA reporting

Guidance on Medical Device Recall

Advertisements and promotions of medical devices
It is the responsibility of the advertiser to ensure compliance with legislation and guidelines for advertisements and promotions of medical devices.

All medical device dealers will need to apply for a dealer's licence before you can import, manufacture and supply your devices in Singapore. HSA will assess if you meet Good Distribution Practice requirements before issuing your licence.