The new article describes in detail the requirements associated with the special pathways to be used to make unregistered medical devices available for healthcare professionals and patients.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to special access routes (SAR) — pathways to be used in case there is no registered medical device that meets specific needs. The document provides an overview of the applicable regulatory requirements and also highlights the key points to be considered by all the parties involved. At the same time, provisions of the guidance are non-binding, neither is intended to introduce new rules or impose new obligations.
Application Requirements: Key Points
The scope of the guidance covers, inter alia, the requirements related to the SAR, including the list of documents to be submitted by an interested party. According to the guidance, depending on the specific pathway, the application shall contain such documents as:
- Instructions for Use, Product Insert, or Operations Manual by the product owner;
- Primary medical device label;
- A copy of the qualified practitioner’s registration;
- A copy of the PHMC/ HCSA License of the requesting healthcare facility, with the License Number legible;
- A copy of the quality management system certificate (e.g. Good Distribution Practice for Medical Devices (GDPMDS)) if a valid Importer license with GDPMDS is unavailable;
- Request form for an unregistered medical device for use on patients by QP and licensed healthcare facility (the authority additionally emphasizes that clinical justification shall reflect special clinical need);
- Clinical Justification Review Form;
- Label with a statement “for supply for the non-clinical purpose only”;
- SMDR listing number of the original registered medical device;
- Documentary evidence to show that the medical device is registered in the exporting country e.g. free sale certificate;
- A certified true copy of ISO 13485 certificate for each of the manufacturing sites;
- Copy of invoice from exporting company indicating the lot number/serial number of each of the medical devices to be imported;
- Attestation from product owner that the medical device is identical to a registered medical device in Singapore, including the manufacturing site, packaging, and labeling;
- Undertaking by the importer to take responsibility for the quality, safety, and performance of the medical device to be imported.
pplication Process in Detail
The document further describes in detail the application process to be followed for an interested party to obtain permission to import and use a medical device that is not duly registered in Singapore. First of all, the HSA mentions that all interactions with the authority concerning Special Access Routes should be carried out via the Medical Device Information and Communication System (MEDICS), a special system for online submission.
According to the guidance, the whole process is comprised of the following steps:
- An interested entity shall apply for CRIS Company Account which is necessary to submit electronic applications and interact with the authority;
- Once the above account is created, an interested party shall apply for SAR to be accompanied by all the supporting documents required. The authority additionally emphasizes that only the importer is eligible for applying for SAR.
- The authority will review the application submitted within 14 business days. However, in the case of applications related to class D medical devices, the review timeline could be extended due to the specific nature of such devices and the high risk associated thereto.
The document also outlines eligibility criteria both the applicant and the product in question should meet for the SAR application to be admissible. As in the case of other requirements, the particular eligibility criteria to be applied will depend on the specific pathway to be followed.
According to the guidance, eligibility criteria for the product include the following ones:
- The medical device in question should be approved by at least one trusted national regulating authority in the sphere of healthcare authority. The ones recognized by the HSA are the Australian Therapeutic Goods Administration (TGA), Health Canada (HC), Japan Ministry of Health, Labor and Welfare (MHLW), US Food and Drug Administration (US FDA), and European Union Notified Bodies (EU NB).
- In certain cases, the medical device should be registered in the Singapore Medical Device Register (SMDR), a country’s register of healthcare products allowed for marketing and use.
The list of pre-requisite requirements an importer should meet includes, inter alia, the following ones:
- Certified quality management (e.g., to the requirement of Good Distribution Practice for Medical Devices, GDPMDS);
- A valid importer and wholesaler license with Good Distribution Practice for Medical Devices (GDPMDS) or ISO 13485.
As further explained by the HSA, the application fee will be charged in full once the application is submitted via the aforementioned electronic submission system. The authority additionally emphasizes that the said fee is non-refundable. Moreover, once the application has been approved, it cannot be amended. Hence, should an interested party decide to make any changes, a new application is to be submitted.
Apart from the abovementioned requirements, the document also highlights the key points to be considered concerning medical devices intended to be made available under the SAR, namely:
- An applicant shall be responsible for ensuring that the device subject to review is fully compliant with any applicable regulatory requirements;
- When the SAR application is reviewed, the authority does not access the safety and performance of the device in question;
- An authorization granted under SAR will remain valid for 12 months from the date it has been granted. Within this period, it can be used to import multiple consignments (however, an authorization under the GN-30 pathway allows only one consignment to be imported). Once the said authorization has expired, no import or supply is allowed.
- The authorization holder is the only entity allowed to supply the device covered by the SAR application.
In summary, the present guidance provides an overview of the regulatory requirements to be applied concerning Special Authorisation Routes to be used to make unregistered medical devices available in Singapore. The document outlines the key points to be taken into consideration by the applicants and also describes in detail the application process.
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