The realm of medical device registration in Singapore comprises a intricate network of rules, recommendations, and procedures designed to guarantee the safety and effectiveness of healthcare products. Singapore, renowned for its stringent criteria and dedication to innovation, provides a multitude of options for registering medical devices to accommodate a diverse array of products and producers. This article explores the various registration routes accessible in Singapore, emphasizing their distinct characteristics and guiding manufacturers in selecting the most appropriate path for their medical devices.
Understanding the Medical Device Ecosystem in Singapore
Before we explore the registration options, it's essential to have a firm understanding of the regulatory structure overseeing medical devices in Singapore. The Health Sciences Authority (HSA) serves as the regulatory entity tasked with ensuring that medical devices adhere to requisite safety, quality, and performance criteria before they are permitted for market distribution. The HSA categorizes medical devices according to their risk level, spanning from Class A (minimal risk) to Class D (significant risk).
The classification system for In Vitro Diagnostic Devices (IVDs) in Singapore diverges from that applied to medical devices. IVDs in Singapore undergo classification according to the risk they present to both individuals and public health.
Overseas Reference Regulatory Agencies
Singapore acknowledges specific regulatory authorizations granted by overseas nations like Australia, Canada, Japan, the United States, and the European Union. These entities are referred to as overseas reference regulatory agencies.
Medical Device Evaluation Processes in Singapore
The Health Sciences Authority (HSA) in Singapore offers four distinct evaluation routes for processing applications related to medical device registration. These routes include Full Evaluation, Priority Full Evaluation, Abridged Evaluation, Expedited Abridged Evaluation, and Immediate Registration Process. The determination of the evaluation route hinges on the following factors:
The device's assigned risk classification.
The number of previous approvals obtained from relevant overseas regulatory bodies (such as Australia, Canada, Japan, the US, and the EU).
The extent of available safety data and the device's historical marketing record.
Full Evaluation Route
Medical device registration in Singapore follows the Full Evaluation Route when the medical device lacks approval from any of the overseas Reference Regulatory Agencies. In this scenario, the medical device undergoes a comprehensive evaluation process because it doesn't meet the criteria for Abridged Evaluation, Expedited Abridged Evaluation, or Immediate Registration. Even if the device does qualify for either the Abridged Evaluation or Expedited Abridged Evaluation process, the applicant has the option to voluntarily opt for a Full Evaluation process for their medical device.
Priority Full Evaluation
It's important to consider whether your device is eligible for the Priority Review Scheme, which can significantly expedite the time it takes to bring your product to market. As part of the Full Route, the Health Sciences Authority (HSA) has introduced the Priority Review Scheme to accelerate approval for certain devices that haven't yet obtained regulatory approval overseas. The medical device must fall into any of the five specific focus areas of Cancer, Diabetes, Ophthalmic diseases, Cardiovascular diseases or Infectious diseases
Additionally, the device must be designed and validated to address an unmet clinical need. This means there is no existing treatment for the specified condition, or it represents a breakthrough in technology. This further underscores Singapore's commitment to fostering innovation. To be eligible for the Priority Review Scheme, your device must meet both of these criteria; otherwise, it will follow the standard Full Evaluation Route.
A Class B, C, or D medical device may be considered for assessment through a Priority Full Evaluation process if it either falls into the category of medical devices that require a Full Evaluation process or is deemed novel by the Health Authority. If a Class B, C, or D medical device meets the prescribed criteria, it can potentially qualify for Priority Full Evaluation, provided that the relevant fee stipulated in the Fees Regulations is paid.
Abridged Evaluation Process
The Abridged Route comes into play when your device has received approval from at least one of the overseas reference regulatory agencies, regardless of its risk classification. A medical device may become eligible for evaluation through an abridged evaluation process if it meets the following criteria:
Any competent regulatory authority in a foreign jurisdiction has granted approval for the distribution of the medical device in that jurisdiction.
The approval from the competent regulatory agency aligns with the types recognized and listed on the Health Authority's website at the time of the medical device registration application.
The medical device also complies with all other conditions specified on the Health Authority's website.
Expedited Abridged Evaluation
This represents another expedited approach for medical device registration in Singapore, although it takes into account both overseas approval and the device's risk classification. Only Class C and Class D Medical Devices can be evaluated under the Expedited Abridged Evaluation. If the medical device falls under the Class B classification, it is not eligible to utilize the Expedited Route. In such instances, the Immediate Route is a viable option provided all the requirements for the route are fulfilled.
If your device falls under Class C and meets the following criteria:
It has received approval in at least one overseas reference country.
It has been on the market for a minimum of three years in these overseas reference countries.
There have been no global safety issues reported with your device.
There have been no prior rejections or withdrawals by either HSA or overseas reference regulatory agencies.
If your device is classified as Class D and meets the following criteria:
It has obtained approval in at least two overseas reference countries.
There have been no prior rejections or withdrawals related to quality, performance, or safety by either HSA or overseas reference regulatory agencies. You can also use the expedited Route.
Certain devices have been deemed ineligible for the Expedited Route by Singapore authorities, primarily as a response to recalls and significant incidents that have occurred globally in recent years.
HSA defines these 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.
Immediate Registration Process
The Health Authority has the option to promptly register a medical device if the following conditions are met:
The medical device holds approvals from a minimum of two reference regulatory agencies, each located in a foreign jurisdiction, permitting the distribution of the medical device within their respective regions.
The approvals granted by each of these reference regulatory agencies align with the types accepted by the Health Authority and are listed on the Health Authority's website at the time of the medical device registration application.
The medical device also adheres to all other conditions outlined on the Health Authority's website.
Immediate Registration Process for Standalone Mobile Applications-
The Health Authority has the option to swiftly register a Class B medical device or a standalone mobile application categorized as Class B or C, provided that the following conditions are met:
At least one reference regulatory agency in a foreign jurisdiction has granted approval for the distribution of the medical device within that jurisdiction.
The approval from the reference regulatory agency aligns with the types recognized by the Health Authority and is listed on their website at the time of the medical device registration application.
The medical device also conforms to all other conditions detailed on the Health Authority's website.
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. Navigating the medical device registration landscape in Singapore requires a deep understanding of the available pathways and the unique requirements of each. Whether manufacturers are dealing with lower-risk devices, innovative technologies, or custom-made solutions, the Health Sciences Authority (HSA) has designed a range of pathways to accommodate diverse products while ensuring patient safety and product efficacy. By choosing the right registration pathway, manufacturers can confidently bring their medical devices to the Singaporean market, contributing to the nation's reputation as a healthcare leader and innovator.