The article provides a general overview of the regulatory framework for product registration submissions, including the relevant procedures for applying for marketing approval in Singapore.
Table of content
The Health Sciences Authority (HSA), Singapore’s regulatory agency in healthcare products, has published a guidance document dedicated to product registration submission.
The document provides an overview of the applicable regulatory requirements and additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, and they are not 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 corresponding amendments to the underlying legislation.
In particular, the document outlines the scope of information to be included in the market application submissions to ensure their completeness.
Regulatory Background
The guide is designed to assist stakeholders in submitting product registration dossiers for in vitro diagnostic medical devices through the Medical Device Information and Communication System (MEDICS).
It details the process for uploading documents related to either the ASEAN Common Submission Dossier Template (CSDT) or the International Medical Device Regulators Forum (IMDRF) Table of Contents (ToC).
Medical device product registration applications, specifically for in vitro diagnostic devices, should be submitted online through MEDICS, utilizing the CSDT or IMDRF IVD MA ToC.
This initiative underlines the shift towards digital submission processes, streamlining technical dossier and supporting document submissions in softcopy format.
The scope of the document exclusively covers the submission procedures for in vitro diagnostic medical devices, emphasizing the significance of complying with specific guidelines to facilitate the registration process.
Submission Guidelines
The document further provides detailed guidelines explaining the approach to be followed when preparing and filing the submission associated with a healthcare product.
MEDICS Application Form
According to the document, an important step involves submitting the technical dossier and supporting documents under designated modules within the MEDICS application form’s “Dossier & Supporting Document(s)” section.
Applicants must ensure the accurate uploading of documents, supported by meaningfully named files for more accessible review and identification.
Submissions Based on CSDT and IMDRF nIVD ToC
The guide specifies how CSDT or IMDRF IVD ToC sections should be uploaded across different modules within MEDICS, ensuring a structured and organized submission process.
The document also describes a mechanism for responding to queries, requiring written responses and, where necessary, additional document submissions to support claims or clarifications.
The document further outlines the submission requirements based on the evaluation route (Full, Abridged, Expedited, Immediate), drawing attention to the documentation required across various categories such as authorization letters, device configurations, reference agency approvals, marketing history, safety issues declarations, and more.
In particular, the HSA provides a comprehensive checklist, ensuring applicants know the requirements for each submission type.
According to the guidance, the applicant is expected to provide:
- Authorization Letters: Confirm the registrant’s authority to register the product, adhering to the latest templates.
- Device Configurations: A detailed list in a specified format highlighting device configurations relevant to the submission.
- Reference Agency Approvals: Proof of approval from agencies is crucial for the registration process.
- Marketing History: Documents proving the device’s marketing history in reference agency jurisdictions, underscoring market acceptance, and usage.
- Safety Declarations: A declaration regarding global safety issues affirming the device’s safety profile.
- Executive Summary: Provides a comprehensive overview of the device, its intended use, unique features, and market history.
Design and Validation
As further explained by the authority, the parties responsible for medical devices are expected to provide additional information about the design of the products in question, as well as validation activities conducted.
The authority expects an exhaustive description of the device, its design, features, and connectivity, alongside a detailed validation and verification process including preclinical studies, metrological requirements, and sterilization validations to be provided.
This ensures a thorough understanding and demonstration of the device’s efficacy, safety, and compliance with regulatory standards.
Labeling and Clinical Evidence
The document also specifies the relevant requirements for device labelling, including primary and secondary labels, package inserts, and instructions for use.
Clinical evidence, as a clinical evaluation report, substantiates and supports the device’s clinical utility and safety, adhering to specific sensitivity, specificity, and method comparison standards.
Risk Analysis, Manufacturing, and Quality Assurance
Apart from the matters outlined hereabove, the scope of the guidance also covers the aspects associated with the risk analysis, manufacturing process, and quality assurance to be conducted to ensure the device meets the applicable requirements in terms of quality.
- Risk Management: A detailed risk analysis, including identification, severity, probability of occurrence, and mitigation measures, assures the comprehensive management of potential risks associated with the device.
- Manufacturing Information: Details on manufacturing and sterilization sites are required to confirm the device’s production adheres to quality standards, ensuring safety and reliability.
- Quality Management System (QMS) Proof: Evidence of compliance with QMS standards (e.g., ISO13485 Certificate, MDSAP Certificate) from manufacturing sites reinforces the commitment to maintaining high-quality production processes.
Conclusion
The present HSA guidance provides an in-depth description of the supporting documentation and information to be included in the submission associated with a medical device intended to be marketed and used in Singapore.
The authority highlights specific aspects to be addressed in the submissions and provides additional clarifications regarding the structure and content of the submission.
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