The article addresses the aspects related to elements of the submission template associated with the device description and information about the product to be provided by the applicant for the authority to be able to conduct a review.
Table of Contents
The Health and Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the registration of in vitro diagnostic (IVD) medical devices in the context of the ASEAN CSDT.
In particular, the document describes in detail the content of registration submissions and highlights the key points to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance with the applicable regulatory requirements.
The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the relevant legislation.
The scope of the guidance covers, inter alia, the aspects to be addressed in the submission with respect to the device description.
The authority explains in detail what is expected from the applicant to be included in the submission in order to ensure its completeness.
Intended Use
The concept of the “intended use” refers to the specific purposes for which a medical device has been designed, developed, and manufactured.
Another factor to be taken into consideration when determining the intended use is the information indicated in the instructions for use provided by the manufacturer.
For the products marketed as IVD devices, the details provided should include:
- Analyte/Measurand of the Assay: This refers to the specific substance or component the assay is designed to measure or detect.
- Quantitative or Qualitative Nature: This distinction is used to determine if the test measures the exact quantity of an analyte or simply detects its presence or absence.
- Role in Clinical Usage: Tests can serve multiple purposes, such as diagnosing conditions, monitoring the progress of a disease, or even assisting in diagnosis, so it is vitally important to specify which role the particular device plays.
- Disease or Condition Addressed: This criterion refers to a specific medical condition the test is intended to address.
- Specimen Type: It is vitally important to state whether the device works with specimens like blood serum, plasma, or any other bodily sample.
- User Classification: It is also necessary to categorize the users – whether the device is made for use by individuals at home (self-testing), by trained technicians in a near-patient setting, or by healthcare professionals in clinical environments.
- Assay Type: Descriptions could range from immunoassays, which detect the presence of specific proteins, to chemistry-based tests or more specialized assays like immunohistochemistry.
- Associated Instruments: In situations where a specific instrument is essential to conduct the assay, its name or type should be highlighted.
Instructions of Use and Limitations
The manufacturer should provide a detailed set of guidelines on how to use the medical device in a proper way to ensure safety and effectiveness.
Instructions could range from the exact methods and procedures to employ, the frequency and duration of use, to the correct quantity (if applicable) and preparations required.
To increase accessibility, such details should ideally be inscribed directly on the device or its packaging where possible.
Limitations
The authority acknowledges that every medical device has its constraints and limitations for use.
The appropriate section should outline the conditions, diseases, or specific patient groups for whom the device might not be appropriate.
Such information is vitally important to prevent misuse and potential harm.
To illustrate the approach, the authority provides as an example a situation when test results could be potentially affected when used for patients previously treated in a specific way.
Warnings and Precautions
By the applicable regulatory requirements, safety-related matters are vitally important.
The warnings ensure users are duly informed of specific hazards associated with the device. This becomes especially important for devices containing materials that might pose risks, e.g., biological, radioactive, etc., – in such a case, the appropriate warnings should be provided.
The document also pays special attention to precautions intended to emphasize the special care required to ensure the device is used safely and efficiently.
While not always life-threatening, overlooking these precautions can lead to undesirable consequences for patients or the device itself.
The guidelines medical device manufacturers are expected to provide could include, inter alia, handling instructions and storage recommendations.
Materials
According to the guidance, the authority expects medical device manufacturers to provide a comprehensive breakdown of the materials used in the device subject to review.
The authority additionally emphasizes the importance of ensuring that any components of the product are duly listed.
If components derive from biological sources or are produced using recombinant techniques, detailed information about their origin, production, and processing is required.
Other Relevant Specifications and Information
Apart from the general description of the functionality of the device in question, the authority also expects medical device manufacturers to provide information about the most important characteristics of the product, such as accuracy, sensitivity, reliability, etc.
Furthermore, the authority also mentions that there could be additional characteristics falling outside the categories outlined above but still important.
All such aspects should be duly covered by the device description the authority expects medical device manufacturers to provide when applying for marketing approval.
In summary, the present guidance outlines the scope of information to be provided by the medical device manufacturer when it comes to the device description included in the submission.
The authority highlights the key points to be addressed and provides additional information about the details to be included.
Other Relevant Specifications and Information
Apart from the general description of the functionality of the device in question, the authority also expects medical device manufacturers to provide information about the most important characteristics of the product, such as accuracy, sensitivity, reliability, etc.
Furthermore, the authority also mentions that there could be additional characteristics falling outside the categories outlined above but still important.
All such aspects should be duly covered by the device description the authority expects medical device manufacturers to provide when applying for marketing approval.
In summary, the present guidance outlines the scope of information to be provided by the medical device manufacturer when it comes to the device description included in the submission.
The authority highlights the key points to be addressed and provides additional information about the details to be included.
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