The new article describes in detail specific aspects related to the regulatory framework for the importation of medical devices intended to be used for exhibition purposes.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the importation of unregistered medical devices for exhibitions in Singapore. The document provides an overview of the applicable regulatory requirements, as well as recommendations to be followed by the parties involved to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, and could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying regulations.
The authority also mentions that in certain cases, the actions should be coordinated with other regulating authorities as well. For instance, in case the product to be imported for exhibition purposes is a radiation-emitting device, an interested party should also contact the National Environment Agency (Radiation Protection and Nuclear Science Department).
As it was mentioned before, there are two possible importation routes: as cargo goods and via hand-carry. The authority further describes each of them in detail.
- Import as Cargo Goods. A Singapore-based entity may import unregistered medical devices on behalf of the exhibitor. In such a case, the appropriate approval should be obtained by this entity. This approval will specify that unregistered medical devices could be important to be used in the course of a specific event, the use should be limited to a specified period, while the importation may occur in multiple consignments.
- Import via Hand-Carry by Exhibitor. Alternatively, a limited number of unregistered medical devices could be imported via hand-carry. In such a case, an exhibitor will be solely responsible for ensuring compliance with the applicable regulatory requirements, including the ones related to customs and shipment. For this type of import, a license will be issued directly to the exhibitor, as there will be no third party (importer) involved.
Handling of Devices
The scope of the guidance also covers the aspects related to the handling of unregistered medical devices during the exhibition. As the key point, exhibitors are responsible for ensuring that the products imported for exhibition purposes are not supplied and used in the country. Furthermore, any unregistered medical devices demonstrated at the exhibition should be marked with the label as follows: “SOLELY FOR DISPLAY PURPOSES ONLY. NOT INTENDED FOR SUPPLY”. As it was mentioned before, in no event such devices should be used for clinical purposes. However, they still could be activated for demonstration purposes, provided this will not result in any person being exposed to any risk. In this respect, it is important to mention that the National Environment Agency (NEA) has prohibited the energizing or switching on of medical devices which can emit radiation such as X-ray equipment and lasers in the public unless the appropriate radiation licenses have been obtained from NEA.
The document also describes the way the unregistered medical devices imported for exhibition purposes should be handled after the exhibition for which they were initially imported. By the applicable regulatory requirements, all such products should be duly exported outside the country or destroyed, depending on the conditions outlined in the license issued to the importer. In no event, such devices should become available for distribution and use in Singapore.
Application Process in Brief
To assist the parties involved in following the recommendations provided herein, the guidance also contains the flowchart demonstrating the entire process in detail. According to the flowchart, the said process is comprised of the following steps:
- Submission of an application for permission to import unregistered medical devices for exhibition by an interested party (importer/exhibitor). The authority mentions that online form 32 should be used.
- Review of the application by the regulating authority. At this stage, the authority is entitled to ask for additional clarification (e.g., missing documents, deficiencies, etc.). Upon completion of the review, the authority takes a regulatory decision concerning the application submitted. According to the guidance, the whole review process should have a Turnaround Time (TAT) of approximately 10 business days.
- Import of unregistered medical devices by the conditions outlined in the license granted by the authority.
In summary, the present HSA guidance describes in detail the regulatory requirements to be taken into consideration concerning the import of unregistered medical devices to be used (demonstrated) in the course of an exhibition taking place in Singapore. The document outlines the key aspects related to the application process, the responsibilities of the parties involved, as well as the specific steps to be taken. By the virtue of the guidance, the authority additionally emphasizes the importance of ensuring that the unregistered medical devices imported for exhibition purposes will not be marketed and used in Singapore.
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