In the world of healthcare, regulatory compliance is the foundation upon which patient safety and industry integrity are built. That is why when it comes to introducing a medical device to the Singaporean market, there are stringent demands of regulatory compliance to ensure utmost safety, reliability and efficacy.
In this blog, we delve into the medical device registration process in Singapore, ensuring you adhere to the necessary regulations and providing essential insights for a successful registration.
Understanding the Medical Device Registration Regulatory Framework in Singapore
The Health Sciences Authority (HSA) in Singapore plays a pivotal role in the evaluation and approval of medical devices. Companies must secure a dealer’s license prior to engaging in the manufacturing, import, or distribution of medical devices. It is a prerequisite that all medical devices undergo registration with HSA before they can be legally distributed in Singapore.
The evaluation route for your medical device depends on several factors, including the risk classification, prior approvals, and the duration of safe marketing history. The risk classification categorises devices as A (low risk), B (low to moderate risk), C (moderate to high risk), and D (high risk). Determining your device’s classification is a crucial first step, and HSA offers a tool to simplify the process.
However, Class A low-risk medical devices are exempt from the product registration requirement. While Class A medical devices are excluded from product registration, it is important to include the Class A Exemption List within your dealer’s license application through the MEDICS platform.
During the evaluation process, HSA will review the information presented in MEDICS and also the CDST that is shared. It is key to be prompt and comprehensive in your responses, as any delay in furnishing the necessary information may result in a longer medical device registration process.
Furthermore, the Priority Review Scheme expedites the registration and market entry process for medical devices, providing a faster route for approval. This scheme is applicable exclusively to Class B, C, and full evaluation route for Class D devices. Take note that Class D devices with a registrable drug in a secondary role are excluded from this scheme. Under the Priority Review Scheme, the turnaround time (TAT) is significantly shorter, with a 25% reduction compared to the TAT associated with the standard full route.
In certain circumstances, the HSA may grant approval for the import and distribution of unregistered medical devices through the utilisation of Special Access Routes. These situations encompass scenarios such as the import of re-export unregistered devices, unregistered devices intended for non-clinical purposes, custom-made medical devices, and various other specific cases.
Tips for a Successful Medical Device Registration
Here are some valuable tips and insights to ensure your journey towards medical device registration in Singapore is not only smooth but also successful.
It is highly advisable to seek assistance from local experts or consultants well-versed in the regulatory landscape of Singapore. Their experience and understanding of the system can help you to navigate the complexities of the medical device registration process with ease, ensuring compliance and efficiency.
At The Reg Consultants, we provide expert guidance and support throughout the entire registration process ensuring compliance with local GN regulations.
Make sure all required documentation is not only complete but also accurate. Attention to detail is critical as any discrepancies or omissions can lead to delays or even rejection of your registration.
Understand Risk Classification
Familiarise yourself with the risk classification system in Singapore. Knowing the category your device falls under is a major factor as it determines the evaluation route and registration requirements.
Compliance with Standards
Your medical device must meet the relevant safety and quality standards. This includes having ISO 13485 certification for medical devices, which is often a fundamental requirement for registration.
Simplifying Compliance at The Reg Consultants
Our mission is clear: to simplify compliance and empower your business to thrive in the complex landscape of medical device registration. With our support, you can navigate compliance with confidence.