The new article outlines the scope of information to be included in the device description and executive summary sections of the submission.
Table of content
The Health Sciences Authority (HSA), Singapore’s regulatory agency in healthcare products, has published a guidance document dedicated to preparing a product registration submission for general medical devices using the ASEAN CSDT.
The document provides additional clarifications regarding the applicable regulatory requirements and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance with it.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
The authority also reserves the right to change the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect the corresponding amendments to the underlying legislation.
Executive Overview
The document outlines the critical aspects of the Common Submission Dossier Template (CSDT), focusing on the regulatory approval process of medical devices.
As explained by the authority, the said template provides for a detailed examination of the device’s intended use, unique features, and commercial history within regulated markets.
Furthermore, it scrutinizes safety performance, regulatory conformity, product configurations, and technical specifications.
Device Overview and Intended Use
This section should provide essential introductory information regarding the medical device, including its intended application and indications for use.
It emphasizes the importance of understanding the device’s target patient demographic, user qualifications (e.g., specially trained professionals), and specific clinical conditions it addresses (e.g., continuous monitoring for critically ill patients).
Moreover, it highlights unique or innovative attributes of the device, such as the integration of nanotechnology or biological components, providing a comprehensive background that situates the device within its broader historical and competitive context.
Commercial Presence and Market Entry
Examining the device’s commercial history outlines its distribution across key regulatory jurisdictions and the initial date of global market introduction.
This historical insight into the device’s commercial deployment contributes to understanding its worldwide impact and regulatory acceptance.
Regulatory Milestones and Approvals
Furthermore, the authority expects the applicant to provide a comprehensive overview of the regulatory statuses of the product in question with the recognized regulating authorities, including submitted, pending, or rejected applications.
This information offers transparency regarding the device’s compliance with international standards, supported by documentation such as approval letters and declarations of conformity from regulatory bodies.
It also addresses discrepancies in device specifications or intended uses across different markets, ensuring clarity in its regulatory narrative.
Safety Performance and Compliance
The document additionally emphasizes the importance of summarizing adverse events and safety actions associated with the device since its market introduction.
This includes a comprehensive review of any corrective measures implemented in response to safety concerns, providing an attestation of the device’s safety track record. The section reinforces the commitment to patient safety and regulatory compliance.
Conformity to Essential Principles
The declaration of conformity to essential principles, supported by a checklist and documentation of compiled standards, underscores the device’s adherence to safety and performance guidelines.
This affirmation of regulatory compliance is crucial for stakeholders to understand the device’s quality and safety benchmarks.
Device Configurations and Specifications
An in-depth description of the device, including its technical specifications, risk classification, and accessory compatibility, offers a thorough understanding of its operational capabilities.
This section emphasizes the importance of software lifecycle management and the documentation of software requirements, reflecting the increasing importance of digital connectivity in medical devices.
Comparative Analysis with Similar Devices
This section provides a contextual understanding of the device’s innovation and safety improvements by drawing parallels with similar or preceding device generations.
Thus, the applicants are expected to give a detailed comparison to similar medical devices already allowed for marketing and use in the country, highlighting the key differences and similarities.
Material Safety and Quality
The document should also critically evaluate the materials used in the device, emphasizing the importance of material safety standards and quality assurance.
This section addresses potential concerns related to material impurities and ensures the device’s compliance with safety and performance standards.
Conclusion
In summary, the template described in the guidance covers the most important matters associated with the medical product undergoing regulatory review before being allowed for marketing and use in the country.
The present document outlines the key aspects to be taken into consideration by the parties applying for marketing approval to ensure the completeness of the information submitted for review.
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