The new article describes in detail the regulatory requirements and procedures related to the renewal of establishment licenses, as well as their suspension or revocation.
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The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the establishment licenses required for the entities intended to carry out operations with medical devices. The document describes in detail various licenses and highlights specific aspects associated thereto. The guidance is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers, importers, and distributors to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, and could be subject to changes, should such changes be required to reflect the respective changes to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to renewal, suspension, and revocation of establishment licenses, as well as to inspections the license holders could be subject to in the course of their activity.
License Renewal
Under the general rule, a dealer’s license is valid for one calendar year from the date it was issued. Should the license holder fail to complete the renewal in time, the license will expire and be no longer valid. The authority additionally emphasizes that no changes could be introduced in the process of license renewal – the changes to the information regarding the license holder are covered by the separate framework.
The authority further explains that all the licenses could be subject to auto-renewal, provided the appropriate fee is duly paid by the license holder. Hence, there is no need in submitting a separate application for renewal. Thus, according to the applicable requirements, the establishment license will be renewed automatically without additional input from the license holder, unless the latter will notify the authority about its intent to opt out. The authority will remind about this option by sending the appropriate notifications 60 and 45 days before the expiration of the current license. The notification will contain detailed instructions describing the particular steps to be performed by the license holder, should it be decided to opt out and avoid auto-renewal of the license. In such a case, the license holder should notify the authority about its intent to opt out at least 30 days before the expiration date.
It is also important to mention that the above approach applies only to the licenses that are on GIRO. For the rest, the manual submission scheme should be applied. Hence, the authority encourages the license holders to join the GIRO payment scheme to simplify and streamline the license renewal process. Should a manual submission of a renewal application be required, such a submission should be performed via the MEDICS e-service. As in the case with the GIRO pathway, the authority will send notifications 60 and 45 calendar days before the expiration date of the current license.
If the license requires manual renewal, the appropriate application should be submitted to the authority before the expiration date to ensure the license is renewed in time, and the entity holds a valid license within the whole period of its activity. The authority additionally emphasizes that all pending amendment submissions made for the license to be renewed have to be approved before a license renewal submission can proceed. The HSA encourages the license holders to submit applications for manual license renewal at least 10 business days before the expiration date to ensure they will be reviewed and the license will be renewed before the current one expires. It is important to mention that it won’t be possible to submit a renewal application in case the saved draft is related to the same license. In such a case, the license holder should finalize and use the existing draft.
License Suspensions and Revocation
The guidance also describes the regulatory approach to be applied concerning license suspensions and revocation. As explained by the HSA, the establishment license could be subject to suspension or revocation in case the authority has reasonable grounds to believe that:
- The issue of the license has been obtained by fraud or misrepresentation;
- The licensee has contravened or is contravening any provision of the Act and Regulations relating to medical devices, any condition attached to the license, or any other prescribed requirement;
- The licensee no longer satisfies any of the prescribed requirements based on which the license was issued; or
- It is in the public interest to do so.
When deciding on suspension or revocation of the license, the authority would also take into consideration the compliance history of the license holder, as well as the risks to the health and safety of patients. Should the authority decide to suspend or revoke the license, the appropriate notice will be provided to the entity in writing. The license holder would be also allowed to provide its response before the license will be suspended. Once the license is suspended or revoked, the entity should immediately cease all operations with medical devices covered by the scope of the license.
At the same time, the authority mentions that the suspended license may be reinstated, provided the issue resulting in suspension has been corrected while should the license be revoked, it cannot be reinstated in the future. However, the entity still may correct the respective issue and apply for a new license.
Inspections
According to the applicable regulations, the authority is entitled to carry out inspections or assessments reasonably necessary to validate compliance of the license holders with the respective regulatory requirements set forth under existing legislation, and any license conditions the holders are subject to. The latter are obliged to ensure compliance with the said requirements within the whole period of their activity related to medical devices.
In summary, the present HSA guidance describes in detail certain specific aspects related to establishment licenses. The document provides additional clarifications regarding the license renewal process and also explains the grounds and consequences for the establishment license being suspended or revoked.
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