The first article highlights the most important aspects related to the application for medical device registration and the way it should be submitted.
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 procedure to be followed by medical device manufacturers when applying for marketing approval required to be allowed to supply medical devices in Singapore. In particular, the guidance addresses the matters related to the submissions filed under the ASEAN Common Submission Dossier Template (CSDT) framework. However, according to the applicable requirements, the International Medical Device Regulators Forum (IMDRF) Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC) could be used as well.
By the device of this guidance, the authority provides recommendations to be taken into consideration when preparing a product registration submission for non-IVD devices. The guidance outlines the scope of information to be included in the respective sections of the application an interested party shall submit. For additional aspects, the authority also refers to the HSA guidance on medical device product registration. The HSA also mentions that the content of the application to be submitted also includes the information outlined in recommendations issued by the Global Harmonization Task Force (GHTF) and IMDRF.
The template described in the present guidance is intended to be used for all submissions related to medical devices that are filed to the respective national authorities of ASEAN member states. The authority explicitly states that the template described in the guidance does not apply to in vitro diagnostic medical devices.
Terms and Definitions
First of all, the guidance provides the definitions of the most important terms and concepts used in the context of the registration process including, inter alia, the following ones:
- Adverse Effect means any debilitating, harmful, toxic, or detrimental effect that the medical device has been found to have or to be likely to have on the body or health of humans when such a medical device is used by or administered to humans.
- Field Safety Corrective Action stands for an action to be taken by a party responsible for a medical device already placed on the market to mitigate the risks associated thereto. As set forth by the applicable legislation, such actions may include:
- The return of the medical device to its product owner;
- Replacement or destruction of the medical device;
- Any action regarding the use of the medical device that is taken following the advice of its product owner;
- The clinical management of any patient who has used the medical device;
- The modification of the medical device;
- The retrofitting of the medical device following any modification to it or any change to its design by its product owner.
- For the guidance, a Product Owner stands for a legal or natural person responsible for a medical device placed on the market under its name or trademark. The sphere of responsibility of a Product Owner may include, inter alia, designing, manufacturing, assembling, processing, labeling, packaging, refurbishing or modifying the health product, or assigning to it a purpose.
Apart from the ones listed hereinabove, the guidance also provides the definitions of such terms as “Adverse Event”, and “Registrant”. About the definition of a medical device, the document refers to the respective regulation. Other related definitions should be found in the Health Products Act and Health Products (Medical Devices) Regulations 2010.
Preparation of the Dossier: Key Points
The HSA further highlights the key points to be considered by a party intended to apply for registration of a medical device to be allowed to place it on the market in Singapore. According to the guidance, these considerations include the following ones:
- The language of the submission should be English. The application should be completed in full, while should some of its elements be not applicable due to the nature of the product in question, the applicant should duly provide the appropriate justification.
- All ancillary materials, including reports, certificates, as well as samples of labeling to be used should be provided as annexes. The authority additionally emphasizes the importance of ensuring that all additional documents submitted are complete and valid at the time of the submission.
- Should the applicant provide any reports, all of them should be duly dated and signed by an authorized person responsible for the sign-off.
As explained by the authority, the level of details it expects to see in the submission depends on the particular pathway to be applied. Following the applicable legislation, these pathways include an immediate, expedited, abridged, and full evaluation.
According to the guidance, the application for registration of a medical device should be filed to the authority via the Medical Device Information and Communication System (MEDICS), while additional documentation described hereinabove should be submitted in soft copies by uploading them via respective modules.
Submission Structure in Brief
To assist medical device manufacturers and other parties interested in placing medical devices on the market, the HSA provides detailed clarifications regarding the structure of the submission and outlines the scope of information each of the elements should contain.
According to the guidance, the submission should include the following sections:
- Overview. The information to be provided in this section includes general descriptive information about the product subject to review, its intended purpose, and indications for use. In particular, the applicant shall provide the details on the user profile and specific conditions in which the device should be used, as well as describe the way the device operates when used for its intended purpose (mode of action). Should the device incorporate towel technologies, this should be reflected as well. In this section, the applicant may also provide any additional general information about the device it found necessary.
- Commercial marketing history. In this section, the applicant should provide the list of countries where the product in question is marketed, as well as the details about the country where it was placed on the market for the first time.
- List of regulatory approval refers to the list of approvals granted by foreign national regulating authorities recognized by the HSA. Copies of the documents confirming the approvals should be provided as well.
- Important safety & performance-related information. The section should contain sufficient information about the reportable events and field safety corrective actions taken for the product, or a declaration signed by the product owner whereby the latter confirms that no adverse events took place to the date of submission.
In summary, the present HSA guidance describes the way the application for medical device registration should be prepared and submitted by a party interested in marketing its product in Singapore. The document provides additional clarifications regarding the submission structure and content of its sections.
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