The article provides an overview of the regulatory requirements related to special application pathways introduced in Singapore.
The Health Sciences Authority (HSA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to Special Access Routes (SAR). The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers to ensure compliance thereto. At the same time, provisions of the guidance are non-binding. The authority also reserves the right to make changes to the present guidance, should it be necessary to reflect the corresponding changes to the underlying legislation. The present document constitutes the third revision of the guidance issued by the HSA.
Under the general rule, any medical devices classified as Class B, C, and D medical devices are subject to mandatory registration before making them available in the country. The respective requirements are set forth by the Health Products Act (Act) and Health Products (Medical Devices) Regulations 2010 (Regulations). However, the authority acknowledges that in certain cases, healthcare professionals may need access to the products that are not registered yet, should it be reasonably necessary to address a specific situation while the registered products do not meet the special clinical needs. As explained by the HSA, special access routes may be used to enable qualified practitioners to access unregistered medical devices for use on their patients.
The guidance further describes in detail the way special clinical needs should be defined, as this is the most important concept related to SAR. The table provided by the HSA outlines the following key points:
- Medical devices on a compassionate use basis. There should be no alternative treatment option, or the options available should be inefficient or unsuitable, while the respective treatment should be vitally important to the patient.
- Alleviation of stock-out situation. In certain cases, unregistered products could be used if there are interruptions in the supply of registered products intended for the same purpose.
- Established medical devices with a history of use. To be eligible for SAR, the product should have a history of successful use while having no safety-related issues associated thereto.
- Novel or established medical devices or upgraded versions of established medical devices (new models/new features). There should be no registered device that meets the needs of a particular patient, while such use should be vitally important.
As further explained by the HSA, the following special access routes could be applied:
- For licensed qualified practitioners to seek approval for the import and supply of unregistered medical devices for use on their patients;
- For healthcare facilities licensed under the Private Hospitals and Medical Clinics Act (PHMCA) / Healthcare Services Act (HCSA) to seek approval for the import and supply of unregistered medical devices for use on their patients.
The authority additionally emphasizes that under the SAR framework, the safety, quality, and performance of the medical device in question would not be assessed. Hence, the applicant requesting the approval will be solely responsible for the use of the product and any issues associated thereto. Furthermore, it is also stated that the patient should be duly informed about the treatment option to be used and provide his explicit consent.
Special Rules for Class C and D Medical Devices
The authority also mentions that in the case of Class C and D products special rules should be followed to ensure they are used to meet genuine clinical service needs. These measures include, inter alia, the following ones:
- Endorsement of SAR application by Chairman of Medical Board (CMB) of the Public Healthcare Institution (PHI) or equivalent. The said rule is also mentioned in the respective applications.
- Review of clinical justification by the Ministry of Health (MOH) for Class D medical devices. The scope of the said rule applies to the products based on novel technologies (or new indications for use), as well as unregistered implants. To proceed with this pathway, an authorized person within the healthcare institution should submit the appropriate application form which can be downloaded from the authority’s website.
On a side note, the authority mentions that the safeguard measures described hereinabove shall not be applied concerning requests from private healthcare facilities. The authority states that such applications could be subject to additional requirements.
Request for Local Clinical Use: Details
The document also provides a flowchart describing the way the request for unregistered medical devices for local clinical use should be submitted.
In case the request comes not from a public healthcare institution, the procedure will be relatively simple – all the documents required should be collected into an application and submitted via MEDICS. The authority will review the application and communicate its decision regarding whether the SAR should be granted.
In case there is a public healthcare institution involved, the process will include a few more steps to be completed. First of all, as was mentioned before, an endorsement from the CMB of PHI will be required (the document also provides a reference to the respective form to be used). If the product in question is an unregistered Class D medical device, it will be also necessary to provide a Clinical Justification Review Form to be filled in by the qualified practitioner of the institution applying for the permission.
According to the guidance, the regulatory framework described therein could also be applied for medical devices intended to be exported, re-exported, or used for non-clinical purposes. In particular, the form GN-28 should be used in the case of import of unregistered medical devices for export or re-export, while the form GN-29 should be used in the case of import of unregistered medical devices for non-clinical purposes.
In summary, the present HSA guidance provides an overview of the regulatory pathway to be used to obtain permission to import and use medical devices that are not duly registered in the country. The document describes the approach to be applied by the parties interested in obtaining such permission and outlines the particular steps to be taken.
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