The article provides additional details regarding the various establishment licenses required to be allowed to undertake the activities in the sphere of medical devices in Singapore. In particular, the document describes the requirements for a dealer’s license and also highlights specific aspects associated with operations with Class A medical devices.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to establishing licenses the parties involved should obtain before manufacturing, importing, or distributing medical devices in the country. The document provides an overview of the applicable regulatory requirements, as well as recommendations to be considered by medical device manufacturers, importers, distributors, and other parties intended to conduct operations with medical devices. At the same time, provisions of the guidance are non-binding and are not intended to introduce new rules or impose new requirements. Hence, in case of any discrepancies with the respective provisions of the underlying regulations, the latter should prevail. Moreover, the authority also reserves the right to make changes to the guidance, should it be reasonably necessary to reflect the respective amendments to the applicable legislation.
Dealer’s License: Key Points
The guidance describes, inter alia, the main requirements related to the dealer’s license and the way it could be obtained. According to the document, to apply for the license, an interested party should submit the respective application via the online MEDICS e-service. The application should contain detailed information about the applicant entity, including contact details the authority may further use in its communications with the applicant, so the latter should ensure that the details provided are accurate and up-to-date.
Apart from contact details, the applicant should provide information on the Quality Management System (QMS) which should be established and maintained throughout the supply chain to ensure that the quality of medical devices is not adversely affected during their distribution and to ensure that appropriate records are kept. Medical device manufacturers can ensure this by following the respective requirements outlined in the standard ISO 13485 so that the final products meet the applicable requirements in terms of safety, quality, and effectiveness.
It is also important to mention that importers and wholesalers of medical devices of risk categories other than Class A medical devices are required to be certified to GDPMDS as a prerequisite for license application. The said certification should be performed by a third-party certification body accredited by the respective authority. However, in case of import for re-export or non-clinical use, such a certification is not required. To be able to benefit from the aforementioned exception, an applicant shall provide the appropriate “Declaration for exemption from GDPMDS”.
In case the applicant entity is going to conduct operations only with Class A medical devices, it would be sufficient to provide a declaration of conformity, while the certification will not be required. The said rule applies to all types of establishment licenses.
As was mentioned before, an applicant shall provide sufficient information about the company which will be the license holder. To identify the entity, its Unique Entity Number (UEN) should be used. The authority additionally emphasizes that the address provided when applying for an establishment license should match the address indicated in the general company’s register maintained by the Accounting and Corporate Regulatory Authority.
Furthermore, it will be necessary to indicate a contact person who should be reached out to by the authority in case there is no way to contact the company. This person will also receive all important updates from the HSA. As in the case of company details, the information about contact persons and/or their contact details should be at all the time accurate and up-to-date.
Class A Products: Specific Rules
The document also describes the approach to be applied concerning Class A medical devices. Since such products are associated with the lowest risk under the existing risk-based classification system, the regulatory requirements to be applied in such a case are less strict than in the case of high-risk products. The entities intended to conduct operations with Class A medical devices should provide the authority with a list of products they will be dealing with, and also keep it up-to-date. Such a list will be publicly available on the authority’s official website. The submission could be perfumed using the MEDICS e-service Amendment for Dealer’s license/Submission of update of Class A Medical Device Exemption List. In case the company is not going to conduct operations with such devices, the appropriate declaration should be submitted as well.
The guidance also outlines the scope of documents to be submitted by an interested entity applying for an establishment license. Depending on the class of medical devices in question, the submission should include either a Declaration of conformity or certification by an independent third-party assessment agency or a Declaration of exemption from mandatory certification; while the declaration letter of non-dealing in Class A medical devices should be also submitted where applicable. As explained before, a Declaration of conformity should be submitted by entities intended to conduct operations with Class A medical devices only. The authority additionally emphasizes that the scope of the ISO 13485 certificate must include the distribution of the categories of medical devices and the activities performed at the facility, where applicable.
To facilitate and streamline the review process, the form should be completed in full and accompanied by the respective supporting documents. The authority reserves the right to reject the application, should the information provided therein be found false or incomplete.
In summary, the present HSA guidance describes in detail the regulatory requirements to be applied concerning a dealer’s license. The document also provides additional recommendations to be considered by the parties intended to deal with Class A medical devices.
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