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Things You Should Know About Medical Device Registration in Singapore

Daniëlle Motta, MSc "Notre équipe Global Registration opère partout dans le monde accéder aux différents marchés. Ensemble, nous déterminons votre stratégie réglementaire globale et une feuille de route cohérente pour rencontrer les exigences locales, obtenir l'enregistrement de vos produits et maintenir votre documentation technique à jour."
Dennis Sarwin, MSc “From the first interview on, I experienced the dynamic, diverse, and honest environment within Qserve. I am eager to apply the acquired knowledge, learned during my studies and prior jobs at medical device companies, on daily basis at Qserve."

Things You Should Know About Medical Device Registration in Singapore I Health Products Act (HPA) and its Health Products (Medical Devices) Regulations 2010

This blog is part of a series of blogs covering general regulatory requirements and developments in Asia-Pacific and LATAM countries. 

In this blog, the jurisdiction of attention is Singapore. Expanding to Singapore before entering other ASEAN markets is often considered a first step to building business in the ASEAN region. Singapore has a well-established regulatory framework whilst the government continuously encourages innovation in the medical device and IVD sector. It is known to be the sandbox for startups and SMEs. Market approval in Singapore can be an advantage in entering other ASEAN markets. 

General information

In Singapore, the Health Sciences Authority (HSA) is the authority 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.

All medical devices are classified based on a risk-based approach comparable to the European Union, FDA, and TGA classification systems. The range spans from Class A, B, C to D, where Class A is low risk, and Class D is high risk.

All medical devices must be registered in Singapore’s Medical Device Information Communication System (MEDICS) and approved by HSA before they can be supplied in Singapore, except for some low-risk Class A devices which are exempted from product registration.

If a company does not have a physical establishment in Singapore, it is required to appoint a local authorized representative, also known as 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.

Before medical devices can be supplied in Singapore, MEDICS must register and approve them. The registration requirements and documentation to be submitted depend on the device’s risk classification and the evaluation routes.

Evaluation routes

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. You could argue that the majority of countries are in line with the countries that participate in MDSAP. This shows that it is useful to consider Singapore as part of your market access strategy in determining your MDSAP approach. It is another angle than usual, but again a great combination where quality and regulations meet again.  

There are four types of evaluation routes; full, abridged, expedited, and immediate. Depending on your overseas approval and available data, you can select the most suitable approach for your device. 

Option 1. Full Route with or without priority

Choosing this Route means your device is not approved in one of the overseas countries described above. 

First and foremost, it is worth assessing if your device fits into the Priority Review Scheme to reduce time to market. As part of the full Route, HSA introduced a Priority Review Scheme to allow certain devices to have a shorter turnaround time and receive approval with urgency whilst not having obtained overseas regulatory approval. HSA has defined five focus areas for this. This means that your device must fall within one of the following categories: 

  • Cancer
  • Diabetes
  • Ophthalmic diseases
  • Cardiovascular diseases
  • Infectious diseases

In addition, the device must be designed and validated for an unmet clinical need. There is no other existing treatment for the specified condition, or it is a breakthrough technology. This shows again Singapore's interest in innovation. To apply for the Priority Review Scheme, your device must meet both criteria; otherwise, you will undergo the standard full evaluation route.  

Option 2. 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. 

Option 3. Expedited Route

This is another fast-track approach, however, not only depending on the overseas approval but also on the risk class of the device. 

Is your device a Class C, and does it meet the following criteria?

The device is approved in at least one of the overseas reference countries and is marketed for three years at minimum in the overseas reference countries. There are no safety issues globally with your device and no prior rejections or withdrawals by HSA or overseas reference regulatory agencies. You can use the expedited Route. 

The device is approved in at least two overseas reference countries, and there are no prior rejections or withdrawals by HSA or overseas reference regulatory agencies concerning quality, performance, or safety. You can use the expedited Route.

Is your device a Class D, and does it meet the following criteria?

The device is approved in at least two overseas reference countries, and there are no prior rejections or withdrawals by HSA or overseas reference regulatory agencies concerning quality, performance, or safety. You can use the expedited Route.

This shows that there are two options for a Class C device within the Expedited Route, whilst only one for Class D. The Singapore authorities decided that certain devices do not qualify for the Expedited Route and need to undergo the Full Route. This is, among other things, a result of recalls and serious incidents that occurred globally over the past couple of years. 

HAS defines the device categories: 

  • Active implantable devices (e.g., pacemakers, neurostimulators)
  • Implantable devices in direct contact with the central circulatory system or central nervous system
  • Hip, knee, and shoulder joint replacement non-bioactive implants (e.g., non-bioactive metal/polymer implants)
  • Hip, knee, and shoulder joint replacement (e.g., bioactive implants)
  • Devices with a registrable drug in a secondary role
  • IVD assays (excluding IVD analyzers) intended for HIV testing (screening and diagnosis) and blood/tissue donor compatibility testing.

You cannot use the Expedited Route when your device is classified as Class B. In that case, verify if the Immediate Route is possible. 

Option 4. Immediate Route  

This Route is for Class B devices. The device is approved in at least one of the overseas reference countries and is marketed for three years at minimum in the overseas reference countries. There are no safety issues globally with your device and no prior rejections or withdrawals by HSA or overseas reference regulatory agencies with respect to quality, performance, or safety. You can use the Immediate Route.

The device is approved in at least two of the overseas reference countries. There are no safety issues globally with your device and no prior rejections or withdrawals by HSA or overseas reference regulatory agencies with respect to quality, performance, or safety. You can use the Immediate Route.

There is a special application for standalone medical mobile applications, both for Class B and Class C devices. The device is approved in at least one of the overseas reference countries. There are no safety issues globally with your device and no prior rejections or withdrawals by HSA or overseas reference regulatory agencies with respect to quality, performance, or safety.

Class A medical devices and IVDs do not need to undergo review and approval through one of the abovementioned evaluation routes. However, an exempt form must be filled in. A Class A Exemption List form in MEDICS should be completed during the dealer's license application. 

Manufacturers are expected to prepare an ASEAN Common Submission Dossier Template (CSDT) for all routes. The level of detail depends on the chosen Route. Information you will need to consider includes design verification and validation, clinical evaluation report, risk analysis, manufacturing process, device description, and labeling. Depending on the Route, HSA accepts summaries, whereas when the full Route applies, all test reports and evidential documents must be provided. In addition to the CSDT, documents such as Letters of Authorization and Overseas Approvals have to be presented. 

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 all done through an online platform, 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.

Renewal of license and maintenance of devices 

Dealers' licenses are valid for 12 months and must be renewed and approved before expiration. It is possible to include amendments to the license in case of changes. For example, an address change is possible whilst maintaining the dealer's license. 

Manufacturers are expected to maintain their device registration and report changes to the submitted documents, including changes to the advertisement and promotional materials and administrative changes. 

Concluding remarks

Singapore is an interesting entry-market that allows manufacturers to leverage their overseas market approval and use it to their benefit. It reduces the turnaround time and cost related to obtaining regulatory approval.  

Qserve can help you register your medical devices in Singapore and other countries. Please contact us if you need any help.

Want to learn more about Asia-Pacific - Singapore and China?
Join us on the 29th of June for a free webinar and Q&A, Medical Device Registration Asia Pacific Part I
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