Singapore Medical Device Registration For Product: HSA Guidance GN-15

Medical Device Registration in Singapore is a controlled procedure that comes through the Health Science Authority. Amongst the major regulatory guidelines for manufacturers, there is the HSA Guidance Document GN-15: Guidance on Medical Device Product Registration. With the latest revision number 13 in March 2026, it provides the required medical devices registration by Health Products Act. This guidance explains the evaluation process of medical devices in regard to quality, safety and performance according to Device Risk Classification before distribution within the Singapore market. To help the process of applying, the manufacturer should use the HSA SHARE platform for all electronic applications. Furthermore, it could be useful to keep in mind that even though Singapore uses its standards, it is important to know the requirements matching Regional Regulatory Frameworks such as Regulatory Reliance Malaysia.

What Are The Latest Updates In GN-15 Product Singapore Medical Device Registration ?

Singapore Medical Device Registration means the process through which the Health Sciences Authority evaluates the technical documentation to identify whether the device meets the requirements of the essential safety and performance principles. As stated by the HSA guideline GN-15, all medical devices (and IVD devices) need to be registered with the Health Products Act prior to being supplied to Singapore, unless otherwise specified as an exemption in the Act and Regulations. The intensity of the regulatory assessment is clearly defined depending on the Medical Device Risk Classification starting with Class A (least risky) up to Class D (most risky). For devices at a higher risk level, the regulatory assessment becomes more intensive and the amount of documentation becomes more significant. It can be prepared using the HSA SHARE Platform. Moreover, for companies planning to operate in the Southeast Asia market, it is useful to be aware of the Regulatory Reliance Malaysia requirements.

Risk Classification: The Foundation Of Compliance

Four categories exist under which the medical devices are classified in Singapore depending on the extent of risk.

Class A - Low Risk

This category includes simple devices like wheelchairs or tongue depressors. Registration of these devices is not mandatory, but they have to be registered under the HSA registry.

Class B - Low to Moderate Risk

This includes devices like hypodermic needles and suction devices. These devices should be registered in the normal course of business with moderate regulatory controls.

Class C - Moderate to High Risk

This category includes devices like ventilators and bone fixation plates. The extent of technical assessment of this category of devices is high due to high risk associated with it.

Class D - High Risk

This category includes devices which are life sustaining and/or implantable devices such as heart valves and implantable defibrillators. The highest degree of regulatory control is imposed on devices of this category.

Singapore Medical Device Registration Streamlined Evaluation Routes

CBEF is employed for HSA medical device registration. The approval from reliable international agencies could greatly shorten the time required for evaluating and approving the medical device in HSA.

These reference agencies include the following:

• U.S. Food and Drug Administration (FDA)

• Health Canada

• Pharmaceuticals and Medical Devices Agency

• Therapeutic Goods Administration

• EU Medical Device Regulation Notified Bodies

Depending on the presence of prior approval from any of these agencies, there are several ways to evaluate the medical device as per Singapore medical device regulations.

1. Evaluation through Full Pathway

For situations where there is no evidence of any approval from reference regulatory bodies. It includes a complete package of technical information and full evaluation.

2. Evaluation through Shortened Pathway

Where there is an approval of the product by at least one reference regulatory body. Manufacturers can submit a summary of the document in such a case.

3. Evaluation through Rapid Pathway

When the product belongs to Class C or Class D and has a lot of reference approvals along with a proven track of safety.

4. Immediate Registration Pathway

Used for Class B products or stand alone medical mobile applications which satisfy the safety criteria. In such a case, products would be immediately registered on the Singapore Medical Device Register. In most cases, manufacturers coordinate with the HSA consultant to make sure that the submission documentation is complete and correct.

The Digital Mandate: Share Platform

One significant regulatory update described in GN-15 Revision 13 is the total deployment of the Singapore Health Product Access and Regulatory E System (SHARE). This system is the primary electronic portal through which all regulatory engagements are carried out between companies and the Health Sciences Authority.

Through SHARE, manufacturers must:

• Submit product registration applications

• Upload technical documentation

• Pay regulatory fees

• Track application progress

After approval, the equipment is automatically included in the SMDR, which is a useful resource for ensuring that companies comply with Singapore medical device laws. Companies often work with a consultant from the HSA to help facilitate their applications.

Regulatory Reliance: Collaboration With Malaysia

Some of the changes made to the GN-15 Revision 13 are the introduction of a Regulatory Reliance scheme for Malaysia. The medical devices that have been certified under the MDA can qualify for the Abridged Evaluation Route process in Singapore.

Some of the conditions are as follows:

• The device must have been registered with the Malaysian MDA.

• The use of the device must be similar to the use of the device in Singapore.

• The device must have been tested by the Conformity Assessment Body.

Exclusions

This process of reliance does not work for:

• Medicinal product in borderline situation

• Device carrying registrable medicinal substance

The current project helps the manufacturer to expand its business operations in the Southeast Asian region without violating regulatory requirements in Singapore medical devices.

Rapid Market Access For Medical Software

The field of digital health is growing rather quickly, and GN-15 Revision 13 tries to give recognition to this by offering clear guidelines on how to go about the assessment of stand alone medical mobile apps.

These apps can be eligible for:

• Immediate Class B Registration (IBR)

• Immediate Class C Registration (ICR)

The medical device becomes listed in the SMDR instantly upon submission and payment.

Eligibility conditions include:

1. There have been no deaths associated with the product

2. There have been no instances of health deterioration worldwide

3. There have been no field safety actions or recalls over the past three years

It is important to note that it is HSA who performs the verification after the submission. If, in turn, the submission is not admissible or incorrect, the registration will be cancelled, and no refunds will be issued. It is a widespread phenomenon when many companies work with an HSA consultant.

Key Compliance Responsibilities For Manufacturers

Manufacturers should remain compliant even post registration.

1. Algorithmic Transparency for Software

In software enabled devices, manufacturers should submit:

Verification and validation of software documentation

Documentation on the management of cybersecurity risks

2. Stop Clock Process

Where HSA seeks additional information, the process of review will be put on hold pending response from the manufacturers. This could lead to elongated timelines for approvals.

3. Post Market Requirements

All registered devices should pay annual retention fees in order to remain on the Singapore Medical Device Registration List. Non payment leads to automatic de registration, thus rendering further supply of such devices illegal.

4. Change Notification

In case of any changes that affect safety, quality, and performance, a change notification is mandatory.

Conclusion

This HSA  Guidance GN-15 (Revision 13) outlines the regulatory process that a manufacturer of a medical device should go through in order to enter the Singapore market. By applying the process of digital submission via the HSA SHARE Platform, adopting Regulatory Reliance Malaysia to simplify the process of regional approvals, and implementing new pathways for digital health technologies, Singapore continues to modernize its regulatory processes related to medical devices. For manufacturers, knowing the Medical Device Risk Classification of their product, as well as having comprehensive technical documentation, is essential for obtaining the Singapore Medical Device Registration.

How Morulaa Can Help

Morulaa makes the process of registration of your medical devices much simpler in Singapore because it correctly categorizes your device to the right risk category (A to D) and quickly determines the most suitable route of evaluation for your device based on your other international approvals. As a result of constant observation of the HSA guidance portal and the SHARE system, Morulaa ensures that all your submissions satisfy the newest regulations regarding cybersecurity and algorithmic transparency. You and your team act as a strategic lead and use the Malaysia Regulatory Reliance pathway.

Product Registration Guidelines

1. GN-15-R13 Guidance on Medical Device Product Registration (2026 Mar) PUB
2. GN-15-R13 ANNEX 1 Letter of Authorisation Template (2026 Mar)
3. GN-15-R13 ANNEX 2 Marketing History Declaration Template (2026 Mar)
4. GN-15-R13 ANNEX 3 Safety Declaration Template (2026 Mar)