Medical Device
A medical device is any instrument, apparatus, implant, machine, product, software, or other similar or related article intended for use in the diagnosis, prevention, monitoring, treatment, investigation, alleviation of disease, or affecting the structure or function of the body. Medical devices range from simple bandages to complex machines such as artificial hearts,
pacemakers, and brain scanners.
The regulation of medical devices varies from country to country. In general, medical devices are classified by risk, and the higher the risk, the more stringent the regulatory requirements. The United States has a three-class system for medical devices, with Class I being the lowest risk and Class III being the highest risk. Singapore also has a four-tier risk-based classification system (Class A-D) with Class A being the lowest risk and Class D being the highest.
Medical Device Registration
In Singapore, all medical devices (except for low-risk Class A devices) need registration with the Health Sciences Authority (HSA) before they can be sold or distributed in the country. Here's a quick rundown of the process:
Registration Authority:
Health Sciences Authority (HSA) https://www.hsa.gov.sg/medical-devices/registration
Classification System:
Singapore uses a four-tier risk-based classification system (Class A-D) with Class A being the lowest risk and Class D being the highest.
Class A devices are exempt from registration but need to be declared during a dealer's license application.
Registration Process:
Registration is done online via the Medical Device Information and Communication System (MEDICS).
The evaluation route for your device depends on its risk class, overseas approvals, and marketing history.
Foreign manufacturers need a Singapore-based registrant to submit the application and represent them to the HSA.
HSA Registration Overview
The Health Sciences Authority (HSA) of Singapore offers a streamlined process for registering medical devices, but the specifics depend on your device's risk classification and how you plan to register it. Here's a breakdown of the key points in an HSA Registration Overview:
Evaluation Routes:
The HSA determines the evaluation route for your device registration. This depends on three factors:
Risk Classification: Class A (low risk) devices are exempt, while Class B, C, and D require registration.
Overseas Approvals: If your device has approvals from recognized regulatory agencies, it can expedite the process.
Marketing History: A proven safe marketing history in other countries can simplify registration.
Registration Options:
The HSA offers different registration routes based on the evaluation criteria:
Immediate Route: This is the fastest option for Class B and C devices with registrations in two reference countries.
Expedited Route: This caters to Class B, C, and D devices with registration in a single reference country.
Abridged Route: This involves a less extensive review for devices with a well-established safety profile.
Full Route: This is the most comprehensive review, usually required for high-risk devices (Class C & D) without overseas approvals.
Additional Points:
Dealer's License: All medical device dealers in Singapore need a license from HSA, which includes listing Class A devices.
MEDICS System: The online Medical Device Information and Communication System (MEDICS) is used for submitting applications and managing registrations.
Priority Review Scheme: This option offers faster registration for certain devices at an additional cost.
Fees and Turnaround Time
The fees and turnaround times for registering a medical device in Singapore depend on the chosen evaluation route and the class of your device. Here's a quick guide:
Fees:
The HSA website provides a detailed breakdown of fees in a downloadable document titled "List of Revised Fees for Health Products" [List of Revised Fees for Health Products ON Health Sciences Authority hsa.gov.sg]. This document outlines the costs for different registration routes and device classes. Here's a general idea:
There's a base application fee of S$560 for Class B, C, and D devices.
Each evaluation route has its own additional fee. Generally, faster routes like the Immediate Route have higher fees compared to the Full Route.
Annual retention fees also apply after successful registration, with costs increasing with device class.
Turnaround Time:
The turnaround time for registration also varies depending on the chosen route. The HSA website offers this information alongside the fee details [Fees and turnaround time for medical devices - Health Sciences Authority hsa.gov.sg]. As a rule:
Faster routes like the Immediate Route offer quicker processing times (within days).
The Full Route, involving a more comprehensive review, takes longer (several months).
Resources:
HSA Medical Device Registration: https://www.hsa.gov.sg/medical-devices/registration
HSA Registration Overview: https://www.hsa.gov.sg/medical-devices/registration
How Bestar can Help
Bestar can be a valuable asset when navigating the medical device registration process in Singapore. Here's how we can assist you:
Expertise in Singapore Regulations:
We possess in-depth knowledge of the Health Sciences Authority (HSA) regulations for medical device registration. This includes staying updated on the latest guidelines, fees, and evaluation routes.
Classification Guidance:
Accurately classifying your medical device (Class A-D) is crucial. Bestar can help determine the appropriate class based on its risk profile, ensuring you follow the correct registration pathway.
Technical Dossier Preparation:
The registration process requires a comprehensive technical dossier containing detailed information about your device. Bestar can guide you on compiling the necessary documents and ensure they meet HSA's requirements.
Liaison with HSA:
We can act as your intermediary with the HSA, handling communication and addressing any queries they may have during the registration process. This streamlines communication and avoids potential delays.
Choosing the Right Evaluation Route:
Selecting the optimal evaluation route (Immediate, Abridged, Full) impacts processing time and costs. Bestar can advise on the most suitable route based on your device's characteristics and existing approvals.
Streamlined Process and Reduced Risk of Errors:
Our experience can help navigate the complexities of the registration process, saving you time and minimizing the risk of errors that could lead to delays or rejections.
Additional Benefits:
Regulatory specialists may also offer services like:
Identifying opportunities to leverage existing approvals from other markets for faster registration in Singapore.
Keeping you informed about upcoming regulatory changes that could impact your device.
Providing post-registration support, such as annual renewal and maintenance of your registration.
Overall, Bestar can significantly simplify and expedite the medical device registration process in Singapore, ensuring compliance and a smoother market entry for your device.
Comments