Singapore's reputation as a global healthcare and innovation hub has made it an attractive destination for medical device manufacturers seeking to introduce their products into the Asian market. However, the regulatory pathway to gain approval for medical devices can be intricate. To facilitate a smoother journey, Singapore's Health Sciences Authority (HSA) offers pre-submission meetings, termed as “Pre-Market Consultation Schemes” designed to provide guidance, ensure compliance, and expedite access to the market. In this blog post, we'll delve into the intricacies of Singapore's pre-market consultation schemes and how they can benefit manufacturers.
The Significance of Pre-Market Consultation
Navigating the complex process of medical device registration in Singapore can be a daunting task. This is where pre-market consultation schemes come into play. They are designed to provide manufacturers with guidance and support during the development or pre-submission phase of their medical devices. These schemes aim to streamline the process, reduce delays, and ensure that medical devices align with Singapore's regulatory requirements.
Navigating Consultation Schemes and Eligibility
Medical device manufacturers have the opportunity to access innovation support during the development or pre-submission phase of their medical devices, expediting patients' safe and effective access to these innovations. The Pre-Market Consultation (PMC) scheme offers consultations that apply specifically to products classified as "medical devices." It's important to note that not all medical devices are eligible for pre-market consultation schemes. Class A medical devices, for instance, are not subject to evaluation and registration, making pre-submission consultation inapplicable for these devices. In such cases, stakeholders may opt for development consultation. Stakeholders must ensure that their product falls under the category of "medical devices" and select the appropriate consultation scheme during the application process. It's essential to be aware that all fees paid are non-refundable.
Pre-Market Consultation Schemes
The Pre-Market Consultation (PMC) Scheme offers manufacturers two distinct consultation categories:
Medical Device Development Consultation
Medical Device Development Consultation
The Medical Device Development Consultation is designed to assist medical device developers and researchers. It serves as a channel for seeking regulatory guidance throughout the different phases of a medical device's development. The Development Consultation phase encompasses the following stages in the medical device lifecycle:
Invention and prototyping
Design validation (pre-clinical)
Manufacturers have the opportunity to consult with regulatory experts to address critical aspects of their medical device's development, such as device claims, safety and performance studies (e.g., sterility and biocompatibility), risk management, and clinical trial strategies. This consultation phase can provide valuable insights to refine and enhance the device's development pathway.
HSA places a cap on the number of products that can be discussed per consultation. Each consultation session can cover either a single device or a group of devices designed to function together as a system. The duration of each Medical Device Development Consultation session is up to 2 hours.
Submission Requirements for Medical Device Development Consultation
To initiate a consultation, the applicant should send the completed form and related documents to HSA_MD_Tech@hsa.gov.sg. The subject of the email must be "Medical Device Development Consultation <Appointment date>." It is crucial that all documents are submitted at least 30 days before the scheduled appointment. Failure to provide complete or sufficient information may lead to the cancellation of the appointment. It's important to note that all fees paid for consultations are non-refundable.
During the application process, it is critical to provide all relevant information. The advice provided during the meeting will be based on the questions or issues outlined in your proposed agenda. Any new information or data presented during the meeting and related issues may not be addressed at the meeting, as the new data and its implications for device validation or development pathways will need to be thoroughly assessed.
When submitting the application, applicants have the option to specify the scope of discussion. This could include General regulatory requirements in Singapore, Risk Classification, Design Validation, Regulatory Strategy, Clinical Trials, Product Claims, or any other areas of concern. Applicants should provide concise questions or areas of concern they wish to discuss during the consultation session and attach supporting information/documents related to these questions. Information can be provided in various formats, such as PowerPoint slides or summary copies. It is essential to keep the supporting information focused on the specific questions at hand, as submitting extraneous information can be counterproductive.
The applicant should also include a brief summary that outlines the product's name, proposed intended use/indications for use (including details on the disease/condition the device is meant to prevent, mitigate, screen, monitor, treat, or diagnose, the targeted population, and the part of the body or type of tissue it interacts with). In the case of In Vitro Diagnostics (IVDs), this summary should also encompass the analyte/condition to be detected and the assay methodology. Furthermore, the summary should provide a description of the device or technology, including:
A concise textual, pictorial, and/or diagrammatic device description (as applicable).
A brief explanation of the mechanism of action, the technology's basis, and, if relevant, how the device's output is utilized.
An explanation of the scientific foundation for the device and/or its expected clinical utility.
A description of the materials used in the device where necessary.
For IVDs, a detailed technical description of the device, including instruments, reagents, components, software, principles of operation, and accessories.
The applicant is also required to provide information regarding the development progress of the device by indicating the appropriate phase in the flowchart below:
IMAGE SOURCE: Health Sciences Authority, Singapore
Pre-Submission Consultation is accessible to stakeholders who are in the process of preparing their device dossier for registration. This consultation serves a critical role in ensuring that all supporting documents are not only complete but also suitable for their intended purpose. Stakeholders can request feedback on the thoroughness and appropriateness of their device dossier before it is formally submitted to HSA.
It's important to note that this consultation can be sought prior to the submission of a registration application and should pertain to a single product registration application. The consultation session is limited to a duration of up to 1 hour.
When applying for Pre-Submission Consultation, the applicant must provide specific details, including the Name of the P
roduct Owner, Name of the Medical Device, Medical Device Type (whether it is a General Medical Device or IVD), Proposed Risk Classification (Class B, C, or D along with the applicable Classification Rule), Proposed Evaluation Route, and Proposed Grouping Type.
How to Apply for the Pre-market Consultation Schemes
The application process for pre-market consultations involves several key steps:
Booking Appointment Online: Applicants should schedule their consultation appointment online approximately five months before the intended consultation date. The online booking form is accessible through MEDICS, HSA's online platform.
Documents Submission: Stakeholders are required to submit the necessary documents at least 30 days before the scheduled consultation date. These documents should include a completed consultation form and all relevant information. It is vital to ensure that the information provided is complete, as incomplete submissions may lead to rescheduling or cancellation of the appointment. Additionally, it's important to be aware that fees paid for consultations are non-refundable.
Request for Information: After reviewing the submitted documents, HSA may request additional information via email before the appointment. Timely responses to these requests are crucial to ensure that the consultation proceeds as planned and to avoid any potential rescheduling or cancellation.
HSA fees for Pre-market Consultation Schemes:
Making Changes to Your Consultation Appointment
The applicant can reschedule or cancel a consultation appointment by sending an email to HSA_MD_Tech@hsa.gov.sg. It should be kept in mind that booking references allow for a single rescheduling opportunity, which is contingent upon availability during processing. The email should comprise the following details, along with three alternative appointment dates ranked according to preference:
Booking Reference No.
Consultation Type: Development Consultation / Pre-submission Consultation
Type of Change: Change appointment / Cancel appointment
Original Appointment Date (DD/MM/YYYY)
New Appointment Date (DD/MM/YYYY)
Navigating the regulatory landscape for medical devices in Singapore can be complex, but the pre-market consultation
schemes offered by HSA are valuable resources that can significantly ease the process. By leveraging these schemes, manufacturers can gain regulatory insights, ensure compliance, and expedite access to Singapore's thriving healthcare market. Whether you are in the development phase or preparing for registration, these consultations can help you navigate the regulatory waters efficiently and effectively.
Ready to navigate the complexities of medical device registration in Singapore and receive expert guidance? Take the first step by scheduling your Consultation with the Artixio team today! Whether you're in the development phase or preparing for submission, our consultation can help streamline your journey toward medical device registration. Don't miss this opportunity to accelerate innovation while ensuring patient safety. Schedule Your Consultation Now !