1. Introduction
•Under the Health Products Act (Act) and Health Products (Medical Devices) Regulations 2010 (Regulations), all Class B, C and D medical devices are required to be registered with HSA prior to placing them on the Singapore market. •In an emergency or in a case where all conventional therapies have failed, qualified practitioners (i.e. doctors and dentists) may need access to unregistered medical devices to meet special clinical needs (refer to Table 1) arising in the course of their practice. •Special access routes may be used to enable qualified practitioners to access unregistered medical devices for use on their patients. Obligations R5 ► Table 1: Definition of Special Clinical Needs Novel or established medical device or upgraded version of established medical device ❑Absence of registered alternatives or lack of a specific feature in registered medical device; or ❑User’s (doctor or dentist) familiarity or expertise in terms of device technology, design and/or operation that is likely to support or enhance the safety outcomes of the procedure or treatment for the patient; and ❑Patient’s health will be clinically compromised without the requested medical device. Medical devices on compassionate use basis ❑Absence of alternative treatment option; or ❑Available alternative treatments failed or deemed ineffective or unsuitable for the patient according to the doctor’s or the dentist’s clinical judgement; and ❑Patient’s health will be clinically compromised without the requested treatment Alleviation of out-of-stock situation ❑The unregistered medical device is needed to minimise disruption to the continued supply of a similar registered medical device Obligations IMPORTANT ❑The safety, quality and performance of the device is not assessed by HSA during application review. ❑As such, the responsibility for prescribing an unregistered medical device rests with the qualified practitioner. ❑The qualified practitioner should also ensure the patient is appropriately informed prior to treatment and consents to the treatment*. The following special access routes may be used to facilitate the import and supply of unregistered medical devices for clinical use: •For licensed qualified practitioners to seek approval for the import and supply of unregistered medical devices for use on his patient. GN-26 •For healthcare facilities licensed under the Healthcare Services Act (HCSA) to seek approval for the import and supply of unregistered medical devices for use on their patients. GN-27 Obligations R3 ► *the doctor has discretion on the format used for this process 1.Endorsement of SAR application by Chairman of Medical Board (CMB) of the Public Healthcare Institution (PHI) or equivalent ❑If the GN-26 or GN-27 application contains unregistered Class C and/ or Class D medical devices, endorsement by CMB of the PHI or equivalent is required. As part of HSA’s efforts to strengthen our regulatory oversight on import of higher risk unregistered medical devices for local clinical use, additional safeguard measures* are required to ensure these devices are used to meet genuine clinical services needs. GN-26 and GN-27 applications with Class C and D medical devices for Public Healthcare Institutions Obligations *Please note that the additional safeguard measures will not apply to requests from private healthcare facilities for unregistered class C and D medical devices at the moment. HSA and MOH will track and review requests for these higher risk medical devices from the private healthcare facilities and introduce additional safeguard measures as required at a later date. GN-26 and GN-27 applications with Class C and D medical devices for Public Healthcare Institutions Obligations For the following specific categories of Class D medical devices: a.New technologies and state-of-the-art medical devices for clinical use on patients, including novel indications for existing medical devices or technologies.They can expose healthcare professionals and patients to significant risks as these unregistered medical devices have not been reviewed by HSA for their safety and effectiveness. b.Unregistered implants (e.g., pacemakers, breast implants) as implants can fail post surgery, and give rise to long term complications, e.g., repeat or revision surgeries, or other clinical interventions that are likely to expose patients to further risks/complications. ❑Applicable only to PHIs that apply for unregistered Class D medical devices. ❑Requesting qualified practitioner/Head of Department (HOD) of the PHI shall complete the Clinical Justification Review Form for unregistered Class D medical devices available on the HSA website. ❑Completed form shall be uploaded and submitted together with the rest of the supporting documents via R5 ► SHARE ◄ 2.Review of clinical justification by Ministry Of Health (MOH) for Class D medical devices GN-26 and GN-27 applications Yes Prepare all required supporting documents and importer to apply for SAR via R5 ► SHARE Request includes unregistered Class D medical devices that fall under the specific categories of Class D devices as per slide 8? Request from Public Healthcare Institution (PHI) for unregistered Class C and/or D medical device? No For SAR applications containing the specific categories of class D medical devices, the SAR application and Clinical Justification Review Form will be assessed by HSA and MOH respectively. *MOH will contact applicant directly for any clarifications related to the Clinical Justification Review Form. Flowchart: Request for unregistered medical devices for local clinical use Requesting qualified practitioner/Head of Department (HOD) of PHI to complete the Clinical Justification Review Form for unregistered Class D medical devices HSA to inform applicant of outcome via R5 ► SHARE Obligations Yes Endorsement from CMB of PHI or equivalent is required. Complete Section E of Request form for unregistered medical device for use on patients by QP and licensed healthcare facility. No •For the import of unregistered medical devices for the purposes of export or re-export Note: -Companieswith existing importer and wholesalerlicencesshall not require GN-28authorisationfor importfor re-export. -Dealersshall be required to maintain documentary evidence of import and supply (e.g. traceability records) as part of their mandatory device distribution records. -Medicaldevices manufactured in Singapore and that are solely for export shall not require GN-28authorisationfrom HSA for their export by the licensed manufacturer •For the import of unregistered medical devices for non-clinical purposes Note: Non-clinical purposes includes any form of use other than use or administration on humans e.g. training equipment (i.e. Not for use on humans); use on animals; or use of in-vitro diagnostic medical devices for research-use only. Special access routes may also be used to facilitate the import and supply of unregistered medical devices for export, re-export or non-clinical purposes, as described below. GN-29 •For the import of registered medical devices on a consignment basis, by dealers not authorised by the Registrant Note: The importation of a medical device which is already registered on the Singapore Medical Device Register (SMDR) shall be performed by a licensed importer authorised by the Registrant only. A dealer who has not been authorised by the Registrant to import a registered medical device may seek authorisation from HSA through this route. Obligations GN-30 GN-28