The new article provides an overview of the regulatory framework for the importation of unregistered products to be used in the course of exhibitions.
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 taking place in the country. The document provides additional clarifications regarding the existing regulatory requirements, as well as recommendations to be considered by medical device manufacturers and other parties involved to ensure compliance thereto. At the same time, it is important to mention that provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations. The authority additionally emphasizes that in case of any discrepancies with provisions of the respective legislation, the latter would prevail.
The present guidance is intended to assist in interpreting and following the applicable regulatory requirements related to obtaining approval from the authority for the importation of an unregistered medical device solely for exhibition purposes. In this respect, the authority additionally emphasizes that the products imported under this pathway should not be used in any other way, including supply to local customers even in the form of free samples. Nor such devices should be used on humans for demonstration purposes. After the exhibition, such products should be exported out of Singapore or returned to the supplier within a specific timeline set forth by the authority.
The existing regulatory framework is based on provisions of the Health Products Act 2007 (Act) and Health Products (Medical Devices) Regulations 2010 (Regulations). As set forth by the said regulations, any medical devices should be subject to registration with HSA before being imported into the country, except in the cases when an exemption applies. Such registration should be carried out by licensed dealers. The applicable laws strictly prohibit the import and supply of unregistered medical devices. The above approach does not apply to the products that are indicated by their manufacturer not to be used on humans since according to the legislation such products are falling outside the scope of medical device definition and, consequently, are not subject to regulation under the framework of the medical device. The authority also mentions that when determining the regulatory status of the product in question, an interested party may use a special Product Classification tool available via the authority’s website.
The scope of the present guidance covers all the cases when unregistered medical devices (irrespective of risk classification) are to be imported into the country for exhibition purposes.
The authority also mentions that local companies exhibiting locally-manufactured medical devices are not required to obtain any approval for displaying their products at exhibitions; however, the manufacturer is still required to display prominent labels or signage that the medical device is not allowed to be used on humans nor supplied for use locally.
Applying for Approval
The document further describes in detail the procedure to be followed by an interested party when applying for approval from the authority to be allowed to import unregistered medical devices for exhibition purposes. As outlined in the guidance, depending on the way the device in question will be imported (e.g., cargo or hand-carry), the list of documents would include information about the exhibition for participation in which the device is being imported, and also a passport page with personal details in case of hand-carry importation or confirmation of the appointment of a local company in case of cargo importation.
The authority also encourages interested parties to submit their applications as early as possible to make sure the approval will be granted in time. It is also mentioned that it can take up to 10 business days to review the application submitted and grant approval. The calculation of the said term will commence upon receipt of a complete application by the authority.
Terms and Definitions
The guidance also provides the definitions of the most important terms and concepts used in the context of the importation of unregistered medical devices for exhibition purposes. For instance, the document defines supply, as initially prescribed by the applicable legislation. According to the Act, supply means to transfer possession of the medical device by any means whether or not for reward, and includes the following:
- To sell the health product, whether by retail, wholesale, or auction;
- To expose or display the health product as an invitation to treat;
- To transfer possession of the health product by exchange, gift, lease, loan, hire, or hire-purchase;
- To supply the health production in connection with a contract for the provision of any goods or the performance of any services, or any advertising, sponsorship, or promotional activity;
- To supply the health product by way of administration to or application in any person in the course of any diagnosis, treatment, or test;
- To offer, agree, or attempt to supply the ways described above, or to cause or permit the health product to be supplied; and
- To keep or possess the health product supply it in any of the ways described above.
The guidance defines supply to outline the scope of actions considered a supply since medical devices imported for exhibition purposes should not be supplied in any way. The document also provides definitions of such terms as “export”, “import” and “medical device”.
In summary, the present guidance provides an overview of the regulatory requirements in the sphere of importation of unregistered medical devices into Singapore for exhibition purposes. The document describes the way the regulatory status of the product should be determined and also outlines the scope of information and documentation to be included in the respective application.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.
Want to know more about our solutions? Speak to a RegDesk Expert today!