The new article addresses aspects related to the way conformity to the applicable Essential Principles should be demonstrated and also outlines the key points to be considered when providing a general device description.
Table of Contents
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the content of a product registration submission for in vitro diagnostic (IVD) medical devices under the ASEAN CSDT. The document (medical device technical reference) provides an overview of the applicable regulatory requirements as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance to it.
At the same time, it is important to mention that 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 make changes to the guidance, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.
The document describes, inter alia, the aspects related to the core elements of the common submission dossier template (CSDT), paying special attention to the applicable essential principles and methods to be used by medical device manufacturers in order to demonstrate the conformity of the products they are responsible for.
Essential Principles
First of all, the authority states that the CSDT should identify the Essential Principles of Safety and Performance of Medical Devices that are applicable to the device … identify the general method used to demonstrate conformity to each applicable Essential Principle. According to the guidance, specific methods used for the above purpose should include compliance with recognized or other standards, state-of-the-art or internal industry methods, comparisons to other similar marketed devices, etc. Furthermore, the CSDT should identify the specific documents related to the method used to demonstrate conformity to the Essential Principles.
According to the guidance, evidence of conformity to the Essential Principles for Safety and Performance of Medical Devices is a key component in the regulation of these devices. Manufacturers are expected to present the relevant evidence in a structured, tabular format, supported by additional documentation that can be made available for review as needed.
This tabular form should align with templates provided in the Annexes of the GN-16 Guidance. As explained by the authority, the completed Essential Principles (EP) conformity checklist can be particularly useful in establishing conformity, especially in cases where a recognized test standard has been employed in the assessment process.
Within the framework of the (CSDT), medical device manufacturers should include a formal declaration of conformity to any standards or other certifications that are permitted by the authority. A summary of the test data should also be included, in particular, if the standard used does not contain inherent performance requirements. Manufacturers are also encouraged to be attentive to details in the CSDT by specifying the full title of the standard, its date, identifying numbers, and the organization responsible for creating the standard. If a manufacturer decides to use internal standards or other means for compliance, those means should be adequately described in the CSDT.
Manufacturers are also reminded that not every Essential Principle may be applicable to all types of medical devices. Thus, it is the medical device manufacturer’s responsibility to assess which principles are most relevant for their specific product, taking into account the intended purpose of the device in question.
Device Description and Features
In addition to a general device description, the guidance states that a more detailed product description is to be provided by the responsible party when applying for marketing approval. Such a description should explain the device’s functionality, provide additional clarifications on the foundational scientific concepts operations of the device are based, and also list all the component materials and accessories used. Moreover, pictorial representations in the form of diagrams, photographs, or drawings should be included to complement the description.
For IVD medical devices, the guidelines are even more specific. A comprehensive list of all components, including antibodies, antigens, and nucleic acid primers, among others, should be provided by the IVD device manufacturer in order to ensure the authority has all the details reasonably necessary for it to complete the assessment. This also covers aspects related to specimen collection and transport materials, as well as characteristics of instrumentation for automated assays. Connectivity capabilities such as the device in question being wireless-enabled or Bluetooth-enabled should be explicitly mentioned in documentation if applicable.
Manufacturers planning to register devices as a group or family should also provide a complete list of the various configurations of the device subject to review. This information should be provided in the Excel template included in Annex 2 of the guidance document issued by the HSA. Additionally, the manufacturer should include a detailed enough description of accessories and other items intended to be used together with the IVD device, such as lancets or other medical devices that may be part of the package.
The HSA also mentions that the risk class and the relevant classification rule for the IVD medical device should be stated clearly, in compliance with the applicable regulations. In accordance with the guidance, the IVD medical device submission for regulatory approval should be accompanied by supporting documentation, formatted in CSDT.
In summary, the present guidance document provides detailed clarifications on establishing conformity to Essential Principles and also on the in-depth description and documentation of IVD medical devices the authority expects the applicants to provide. The HSA highlights the key points to be taken into consideration when preparing and submitting the said documentation in order to ensure the most important aspects are duly addressed.
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