HSA Medical Device Regulations Singapore

Our regulatory consulting specialists support market access in the Singapore medical device market.

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HSA Medical Device Regulations in Singapore

Health Products Act (HPA) and the Health Products (MD) Regulations 2010

HSA Medical Device Regulations in Singapore

In Singapore, the Health Sciences Authority (HSA) is responsible for medical device safety, quality control, and vigilance. The HSA regulates medical devices and in-vitro diagnostic devices under the Health Products Act (HPA) and the Health Products (Medical Devices) Regulations 2010. Qserve supports medical device and IVD manufacturers with the HSA Medical Device Regulations in Singapore.

Medical Device Classification in Singapore

HSA Medical Device Regulations in Singapore

Manufacturers must register all medical devices in Singapore’s Medical Device Information Communication System (MEDICS) and be approved by HSA before manufacturers can supply them in Singapore, except for some low-risk Class A devices. They are exempted from product registration. The registration and documentation requirements depend on the device’s risk classification and the type of evaluation route.

Singapore has recognized certain overseas regulatory approvals from countries such as Australia, Canada, Japan, the US, and the EU. These are known as Overseas Reference Regulatory Agencies. Singapore closely follows the countries that participate in the MDSAP. This shows that it is useful to consider Singapore as part of your market access strategy in determining your MDSAP approach.

Depending on your overseas approval and available data and evidence, you can select the most suitable approach for your device to meet the HSA Medical Device Regulations in Singapore.

Registration routes in Singapore

Submission pathways

There are four types of evaluation routes:

Full Route (with or without priority)
This route applies to devices that are not approved in one of the overseas reference regulatory agencies.
Abridged Route
The abridged route is used when your device is at least approved by one of the overseas reference regulatory agencies, irrespective of the risk class.
Expedited Route
This is a fast-track approach. However, it is not only dependent on overseas approval. This approach is also depending on the risk class of the device.
Immediate Route
This route can be in specific cases depending on the risk class and number of years the device has been marketed without any safety issues.

Find comprehensive details about the evaluation routes in the blog Things You Need To Know about Medical Device Registration in Singapore.

Global regulatory strategy

Expanding to Singapore before entering other ASEAN markets is often considered a first step to building business in the region. Singapore has a well-established regulatory framework, and the government continuously encourages innovation in the medical device and IVD sector. Market approval in Singapore can be an advantage in entering other ASEAN markets. Qserve can support your global regulatory strategy to meet the HSA Medical Device Regulations in Singapore.

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Latest Updates on Regulatory Developments

GN-23 Guidance on labeling for Medical Devices – Introduction of the UDI
GN-16 Guidance on the Essential Principles for Safety and Performance of Medical Devices – Update of Essential Principles for Safety and Performance following the introduction of the UDI
GN-15 Guidance on Medical Device Product Registration – Addition of regulatory approvals for abridged and immediate evaluation routes.

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Qserve services for Singapore

Global Regulatory Strategy
Registration support in Singapore
HSA certification
Singapore Registrant support
Submission file support
Translation labels and IFUs based on requirements

Services

Representation for foreign manufacturers

Singapore Registrant

If a company does not have a physical establishment in Singapore, it is required to appoint a local authorized representative, also known as a Registrant. Any company that wants to manufacture, import, or supply medical devices in Singapore must obtain a dealer’s license, which is usually done by the Registration for foreign legal manufacturers.

More information

Additional Regulatory Requirements

Communication with HSA

All communication regarding the submission and Registration is done through MEDICS. HSA has a fully digitized platform used for all communication. When HSA has reviewed the documents and requires further information, a so-called Input Request (IR) is filled in. The Registrant (or other linked account) receives an automatic notification for this.

Since the submission and review are done online, HSA allows manufacturers to consult pre-market. This is called a pre-market consultation based on the medical device development, usually more clinically focused, or a pre-submission consultation focused on the device dossier and supporting documents.

All communication is usually done in English, and the submission file is also accepted in English.

GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT

Do you need assistance with your strategy for HSA Medical Device Regulations in Singapore?

Qserve is your trusted partner for market access in Singapore.

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Medical Device Registration and IVDs

Achieve regulatory compliance

Our regulatory consulting specialists support market access in the Singapore device market. Based on your current compliance, we can conduct a gap analysis to determine the overlap and missing elements on how to complete the technical documentation efficiently. Qserve knows the essential requirements to ensure how to achieve regulatory compliance.

Regulatory timelines and fees

How long does it take to enter
the Singapore medical device market?

The turnaround times are depending on the risk class and the type of evaluation route:

Class B: up to 160 working days
Class C: up to 220 working days
Class D: up to 310 working days

Important links and guidance

Where to find more information?

How can we help you? Contact us

HSA Medical Device Regulations Singapore

HSA Medical Device Regulations in Singapore

HSA Medical Device Regulations in Singapore

Submission pathways

Singapore Registrant

Communication with HSA

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