The second article of the HSA series provides an in-depth review of the Singapore structure of the submission for marketing approval and the details about the product and manufacturing process it should contain.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the preparation of a product registration submission for general medical devices using the ASEAN CSDT.
The document is intended to provide additional clarifications regarding the content of the submissions, their structure, and information the authority expects to receive from a party applying for marketing approval for the product intended to be supplied to Singapore. In particular, the guidance describes each section of a template the applicants should use and highlights the main points to be covered in each section to ensure the completeness of the information provided.
According to the guidance, the submission should contain a detailed enough description of the device subject to review, sufficient for the authority to assess the safety- and performance-related matters associated with the device. In particular, this section should include the following elements:
- List of configurations, providing information about all configurations available. As it is mentioned by the authority, this document is intended to provide information about all the devices covered by the scope of the submission. Should the grouping be applied, the appropriate requirements should be met for the devices to be eligible for submission within the scope of a single application.
- Comprehensive Device description and principle of operation. This section should provide an exhaustive description of the product subject to review and include details about its functionality, features, and technologies used. If the device is designed in a way allowing it to be connected to other devices, this should be reflected as well. The information could be accompanied by drawings illustrating it. Apart from the aspects outlined hereinabove, this section should also provide the following details:
- Risk class and applicable classification rule for the medical device according to the Regulations.
- Product specifications including the version number of the software if applicable.
- List of medical device accessories intended to be used in combination with the devices. Accessories that can be sold separately should be identified and listed in Annex 2 list of configurations if intended to be supplied in Singapore.
- Reference and comparison to similar and/or previous generations of the device. Should the applicant refer to the safety- and/or performance-related data collected for a similar device already placed on the market, it will be necessary to provide additional information about such devices and their regulatory status, and also a detailed comparison in a form of a table. A comparison should cover, inter alia, the aspects related to the design of the devices, their intended uses, and specifications.
- Materials. The authority also expects the applicants to provide information about the patient-contacting materials used to produce the devices in a form of a list. The scope of information to be provided concerning the materials should be determined on a case-by-case basis deepening on the specifics of the materials used and safety-related matters associated thereto.
Design Verification and Validation
Apart from the information about the device itself, the applicant should also provide sufficient information about the design verification and validation processes and procedures. In particular, this section covers the following aspects:
- Physical and Mechanical Testing, including the respective evidence.
- Electrical Safety & Electromagnetic Compatibility. The applicant shall provide evidence demonstrating that the device meets the requirements set forth by the respective standards.
- Software Verification & Validation Studies. Concerning the assessment undertaken, the applicant should provide the following details:
- Specify the version of the software to be supplied.
- An overview of all verification, validation, and testing performed for the software both in-house and in a simulated or actual user environment before the final release.
- All unresolved anomalies in the release version of the software should be summarized, along with a justification for acceptability (i.e. the problem, impact on safety and effectiveness, and any plans for correction of the problems).
- Biocompatibility. The authority expects to receive the details about the biocompatibility tests performed as prescribed by the respective standards, otherwise, a justification should be provided.
- Devices Containing Biological Material. The applicant should provide exhaustive information about the biological materials used, including the details about risk assessment and measures duly implemented to mitigate these risks. In certain cases, additional certificates would be required.
- Validation of sterilization. The submission should contain the details on the validation of sterilization methods employed by the medical device manufacturer, in case the device is intended to be supplied sterile.
- Stability studies are intended to verify whether the device remains operational when stored within the period of its shelf life as specified by the manufacturer. As is mentioned by the HSA, the applicants are encouraged to provide the data collected in the course of both real-time and accelerated stability studies.
- Animal studies. If the device in question was subject to pre-clinical animal studies, the appropriate information should be provided as well.
- Cybersecurity. The authority pays special attention to the matters related to cybersecurity and risks associated thereto. In particular, it is stated that the applicant shall provide sufficient evidence of compliance with the applicable requirements. The details to be provided include, but are not limited to:
- Cybersecurity vulnerabilities and risks analysis.
- Cybersecurity contort measures.
- Security test reports and/or evidence to verify the device cybersecurity and effectiveness of the implemented cybersecurity control measures (not applicable to IBR & ICR applications).
- On-going plans, processes, or mechanisms for surveillance, timely detection, and management of the cybersecurity-related threats during the useful life of the device, especially when a breach has been detected.
According to the document, the submission should also contain the following elements:
- Clinical Evidence – detailed enough information about clinical trials performed to evaluate the actual safety and effectiveness of the device when used in a clinical environment for its intended purpose. Usually, such information is provided in the form of a clinical evaluation report.
- Samples of Labels on the Device and its Packaging. The applicant should provide examples of labels to be used for the device.
- Instructions for Use (IFU) that will be supplied together with the device, including the indication of the particular format used (either paper or electronic).
- Risk Analysis & Risk Management Report. As is mentioned by the HSA, the applicant shall submit a risk analysis describing the risks identified, the severity of harm, and probability of occurrence including the mitigation measures.
- Manufacturing Information and Manufacturing Process. The applicant should also provide information about any manufacturing facilities involved in the process, together with the respective ISO 13485 certificates.
In summary, the present HSA guidance provides additional details regarding the structure of the submission and information to be included. The document outlines the most important aspects to be considered by medical device manufacturers intended to market their products in Singapore.
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