The new article provides additional clarifications regarding the regulatory status of importers and distributors, as well as warehouses.
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The Saudi Food and Drug Administration (SFDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the requirements for licensing of medical devices establishments. The document provides an overview of the applicable regulatory requirements to be followed by the parties involved in operations with medical devices intended to be marketed and used in the country, as well as recommendations to be considered in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations.
The scope of the guidance covers, inter alia, the regulatory requirements to be applied with respect to importers, distributors, and optical establishments.
First of all, the authority mentions that the establishment is classified according to the electronic questionnaire in Ghad system, which includes type of establishment, activities practiced, number of employees, scope of coverage and type of medical device / requirement, and the general group of the medical device / requirement that will be traded.
The document further describes in detail the general and type-specific requirements to be fulfilled by the entities involved in order for them to be allowed to undertake operations with medical devices in the country.
According to the guidance, specific requirements include, inter alia, the following:
- To appoint a person responsible for interactions with the authority (should have the appropriate qualification in the relevant field);
- To demonstrate compliance with the applicable regulatory requirements by submitting the appropriate evidence;
- To provide information about the medical device manufacturer and the device itself, together with the details of an authorized representative in case of a manufacturer based abroad;
- To develop and implement written procedures prescribing the way the devices should be stored and transported, ensuring compliance with the requirements communicated by the manufacturer;
- To hold a valid warehouse license covering the storing activities;
- To implement an efficient tracking procedure ensuring the key data is being duly recorded (e.g., contact data of the manufacturer, information related to supply, distribution, and use of the medical device, quantities supplied, data of transportation and storage, contact information with users, and information of the medical device in use);
- To keep a declaration of conformity addressing compliance with the regulatory requirements set forth by the Medical Devices Law and Executive regulations associated thereto, issued by the medical device manufacturer.
Apart from the specific requirements to be fulfilled, the document also outlines the main obligations of the parties involved in the importation and distribution of medical devices in the country. According to the guidance, they include, inter alia, the following ones:
- Conducting operations exclusively with the devices that are fully compliant with the applicable regulatory requirements set forth by the Medical Devices Law and the appropriate Executive regulations.
- Making sure all the documents related to the medical device in question are in place, including:
- Confirmation of the medical device manufacturer being informed about the intent of the interested party to place its products on the market:
- Marketing Authorization Certificate,
- Declaration of conformity indicating the compatibility of the medical device with the requirements of the Medical Devices Law and its executive regulations, signed by the manufacturer,
- Unique Device Identification (UDI) of the medical device, which includes the machine-readable code according to the Unique Device Identification for Medical Devices requirements published on the SFDA’s website,
- Identifying information and other relevant documents,
- Contact details of the manufacturer, and the authorized representative if the manufacturer is outside the Kingdom.
- Ensuring compliance with any and all instructions and requirements communicated by the medical device manufacturer with respect to maintenance of the medical device in question and the appropriate post-marketing control requirements issued by the authority;
- Obtaining a maintenance service provider license – in case the entity also intends to provide maintenance services associated with other products
The guidance also describes the requirements applicable to warehouses, as well as the obligations thereof. According to the document, specific requirements of such parties include:
- Appointing full-time technical managers who are biomedical engineers, technicians or qualified in one of the related fields.
- Apply storage and transportation requirements for medical devices which published on the SFDA’s website.
As further explained by the SFDA, the obligations of the entities acting as warehouses include:
- Ensuring continuous compliance with all the requirements set forth by the medical device manufacturer, apart from the ones issued by the authority;
- When storage services are offered to third parties:
- Ensuring all the parties renting the premises have valid storage licenses,
- Having an agreement concluded to cover the main obligations of the parties involved, including the space allocation.
In summary, the present SFDA guidance provides an overview of the applicable regulatory requirements for importers, distributors, and warehouses as set forth under the existing legislation. The document outlines the main responsibilities of the parties and also highlights the key points to be considered in order to ensure compliance thereto based on the type of activities undertaken.
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