SINGAPORE Law and Practice Contributed by: Tony Yeo and Benjamin Gaw, Drew & Napier LLC
• Administrative changes involving changes to administrative documents and information sub- mitted at the point of registration of the medical device. Where the HSA determines that the Change Notifica- tion is approvable, the change to the registered device may be implemented. All other applications (ie, all Notification changes and all other Administrative changes to device particu- lars that are published on the public SMDR listing) may be implemented immediately upon receipt of the acknowledgement email from the HSA. Transfer procedure A transfer application can only be made to the HSA after the medical device is listed on the SMDR and there are no pending applications in the HSA’s system in relation to the device. The new registrant is responsible for making the trans- fer application, by emailing the application form and required supporting documents to the HSA. The new and existing registrants will then be notified of the out- come of the application for the change in registrant. 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations Unregistered therapeutic products may be imported and supplied for patients’ use via the Special Access Route (SAR) under certain circumstances, including the following: • a licensed hospital or medical clinic importing the drug for use by its own doctors or dentists on patients under their care; • a licensed retail pharmacy acting on behalf of, and in accordance with, a valid prescription issued by a registered doctor or dentist; or • a company acting on behalf of a licensed hospital or clinic. However, any such use of unregistered therapeutic products should only be considered for life-saving therapies, and is to be done through either a named- patient application or a buffer stock application.
Note that if the therapeutic product consists of con- trolled drugs or psychotropic substances, the respec- tive licences will also have to be obtained in order to import the product. Unregistered medical devices may be supplied via SAR under a number of exceptions, including the fol- lowing: • for non-clinical purposes; • for export or re-export; or • for patients’ use by qualified practitioners or licensed healthcare facilities, subject to approval. 3.6 Ongoing Obligations Imposed by Marketing Authorisations In general, health products may be registered subject to post-approval commitments. Therapeutic Products Ongoing obligations for registrants of therapeutic products include: • maintaining records of every receipt and supply of the therapeutic product; • maintaining records of defects and adverse effects, and reporting them to the HSA within certain time- frames; • notifying the HSA before any intended recall; • informing the HSA of any information that adverse- ly affects the validity of any data furnished to the HSA; • submitting benefit-risk evaluation reports periodi- cally to the HSA; • implementing risk-management plans; and • informing the HSA of any regulatory actions taken by other regulatory authorities, or actions taken by the company arising from significant safety issues of the therapeutic product. The Regulatory Guidance on Post-Marketing Vigilance Requirements for Therapeutic Products and Cell, Tis- sue and Gene Therapy Products, revised by the HSA in March 2021, sets out further guidance relating to the submission of relevant safety information during the post-marketing phase.
298 CHAMBERS.COM
Powered by FlippingBook