The new article provides an overview of the applicable regulatory requirements for the changes to dealer’s license information and highlights the key points associated thereto.
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 establishment of licenses. The document describes in detail various types of licenses required to undertake activities related to medical devices. The guidance provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers, importers, distributors, and other parties involved. At the same time, provisions of the guidance are non-binding in their legal nature, and could be subject to changes, should it be reasonably necessary to reflect the corresponding changes to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to the changes to the dealer’s license information. According to the applicable regulatory requirements, every licensee is required to notify the Authority whenever there is a change to any particulars formerly declared by him to the Authority at the point of the license application; failure to notify the Authority would invalidate the existing licenses held. The document further describes the approach to be applied by the license holders when notifying the authority about the changes to the main information.
Changes to Applicant Information Section
As it was mentioned before, the license holder is solely responsible for notifying the authority about changes to the information provided in the course of the initial application process to ensure the information held by the authority is relevant and up-to-date. The authority mentions that there is an option to submit information related to multiple medical devices at once.
Changes to License Information Section
First of all, the authority states that in case the license holder decides to change the type of activities undertaken, which requires the changes to the license held, it will be necessary to apply for a new establishment license since there is no procedure for changing the type of the license. At the same time, the amendment application should be submitted by the license holder in case of changes to:
- Device risk classification;
- QMS certification type;
- Certification body;
- QMS certificate expiry date;
- Scope of operations;
- Cold-chain management;
- Operating site address(es) and premises of third-party logistics/outsourced activities.
In case of the changes fall within the scope outlined hereinabove, the authorization holder should duly notify the HSA and provide the updated information. The authority also mentions that changes in the QMS certificate could also require a change notification to be submitted. In such a case, a copy of the respective certificate should be submitted, while the authority reserves the right to request additional information reasonably necessary to assess the changes.
The document further describes the approach to be applied concerning the aforementioned changes, namely:
- Change of risk classification of medical devices – the license holder is responsible for ensuring the accuracy of the classification of products it is dealing with. In case of such changes, an amendment application should be submitted.
- Change of QMS certification type – in such a case, a QMS certificate should be issued by the appropriate certification body (alternatively, a declaration letter could be issued by the entity itself, when applicable).
- Changes in certification body – in such a case, a QMS certificate issued by the previous certification body would be no longer valid, hence, a new certificate issued by the new body would be required.
- Change of certificate expiry date – the updates should be provided each time the QMS expires. For this purpose, an amendment application should be submitted by the license holder, together with the new QMS certificate to be issued instead of the expired one.
- Change of scope of operations – as explained by the HSA, any change in the scope of activities within the licensee’s QMS certificate has to be verified for consonance with the activities authorized in the license, hence, when there is a change in the scope of operations/activities performed by the licensee, the QMS certificate and the “Scope of operation” under license information section shall be updated with the new scope. The authority also mentions that the updated QMS certificate should be provided as well.
- Change of cold-chain management. In case the product in question is subject to cold-chain management, the appropriate storage and transportation conditions should be strictly followed to ensure its continued safety and proper performance. Thus, should such a device be included in the scope of activities undertaken by the license holder, the QMS certificate should be updated accordingly. For this purpose, a license amendment application should be submitted together with the updated QMS certificate.
- Changes in operating site address(es) certified under ISO 13485 (including those of the third-party logistic service providers/outsourced activities) require an updated QMS certificate to be submitted. The new certificate should contain the details of the new sites added. For this purpose, a license amendment application should be submitted. The authority additionally emphasizes that the locations of all the sites involved in operations with medical devices should be indicated in all the documentation.
Changes in Company Information Section
Another important aspect addressed in the guidance is related to the changes in the company information section. As explained by the HSA, it should be notified properly about the changes to the information regarding the company without undue delay. Should the legal entity be changed, a new account in the regulatory system will be required, so the initial license will no longer be valid.
Changes to the Class A Medical Devices
The document also describes the approach to be applied concerning Class A medical devices – the ones with the lowest risk associated thereto. Under the applicable regulatory requirements, changes to the list of Class A medical devices submitted by device dealers (importers and/or manufacturers) during license application shall be updated before import and supply of the devices. Thus, license holders are obliged to submit the appropriate license amendment applications.
In summary, the present document provides an overview of the applicable regulatory requirements concerning various changes to the entity’s license. The guidance highlights the key points to be considered to ensure compliance with the applicable regulatory requirements.
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