The article provides an overview of the applicable regulatory requirements concerning the cancelation of medical device registration.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the cancellation of medical device listing. The document is intended to provide additional clarifications regarding the existing regulatory requirements, as well as recommendations to be considered by registration holders to ensure compliance thereto. At the same time, provisions of the guidance are non-binding, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
In particular, the present document highlights the key points regarding the existing regulatory requirements and also outlines the documents to be submitted to the authority when applying for the cancellation of a medical device listing.
Under the general rule, when a medical device is no longer supplied in Singapore, and/or the registrant is no longer a business entity registered with the Accounting and Corporate Regulatory Authority of Singapore (ACRA), an application to cancel the medical device listing from the Singapore Medical Device Register (SMDR) should be made. Such an application should be submitted by the current registration holder, and be accompanied by the set of documents as prescribed by the applicable legislation.
As further explained by the HSA, upon cancellation of a listing, some of the obligations of a party responsible for a medical device remain in force. For instance, the latter would still have to:
- Maintain records of supply;
- Maintain records of complaints;
- Report defects and adverse effects to the Authority; and
- Notify the Authority concerning field safety corrective action (FSCA), including recalls.
The authority also mentions that in case the registration holder is no longer existing as a legal entity, all the records of supply and complaints related to the device should be duly transferred to and maintained by the initial product owner. In case of a change of registrant, recommendations provided in a respective guidance document will be applicable.
The scope of the guidance covers any medical devices listed in the register and allowed for marketing and use in the country.
Terms and Definitions
The document also provides definitions of the most important terms and concepts used in the context of medical device listing cancellation. For instance, the product owner is defined as a person who:
- Supplies the health product under his name, or under any trademark, design, trade name, or other name or mark owned or controlled by him; and
- Is responsible for designing, manufacturing, assembling, processing, labeling, packaging, refurbishing, or modifying the health product, or for assigning to it a purpose, whether those tasks are performed by him or on his behalf.
Apart from the one described hereabove, the document also provides definitions of such terms as “field safety corrective action (FSCA)”, “registrant” and “supply”. It is important to mention that all the definitions provided in the guidance are initially set forth by the applicable legislation, namely the Health Products Act and the Health Products (Medical Devices) Regulations.
According to the guidance, a registration holder should apply for medical device listing cancellation once the product in question is no longer supplied. The authority additionally emphasizes that for each product owner, a separate application will be required. As it was mentioned before concerning other applications, the system allows only one application to be reviewed at once, hence, before applying to cancellation of a medical device listing, an interested party should make sure there are no other pending applications in the system – if any, they should be either completed or withdrawn beforehand.
The HSA additionally emphasizes the importance of keeping the records of supply and complaints up to the cancellation date – within the period set forth by the applicable legislation – or transferring them to a product owner in case the registrant would no longer exist as a legal entity.
The document further describes in detail the application procedure to be followed by the registrant when applying to cancellation of a medical device listing. According to the guidance, such an application should be submitted via the e-Services module available on the official website of the authority, or in the MEDICS account of the registration holder. The document also provides a flowchart illustrating the procedure to be followed. According to the flowchart, the steps to be completed are the following:
- Ensure medical devices in the listing are no longer supplied;
- All devices listings are from the same product owner;
- Ensure there are no pending change notifications for the device listings;
- Perform a cancellation application in MEDICS.
Cancellation of Medical Device Listing
As explained by the HSA, once the cancellation takes effect, and the device in question is removed from the register, it should no longer be supplied in the country. The authority also mentions that the annual retention fee would not be repaid to the registrant. As it was mentioned before, some of the obligations of the registration holder remain in force even after the cancellation of a medical device listing (the ones related to reporting and record-keeping), unless they are transferred to the product owner due to the liquidation or reorganization of a registrant as a legal entity.
In summary, the present HSA guidance provides an overview of the regulatory requirements related to the cancellation of medical device listing. The document describes in detail the procedures to be followed by the registration holder when applying and also highlights the key points to be considered in this respect.
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