SFDA Guidance on Establishment Licensing: Manufacturers and Authorized Representatives

Table of Contents

The Saudi Food & Drug Authority (SFDA), the 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 additional clarifications regarding the regulatory requirements to be followed by the entities involved in operations with medical devices allowed for marketing and use 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 thereto, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations. 

The document describes, inter alia, operator-specific requirements to be followed depending on the role of an establishment in question, e.g., a medical device manufacturer, its authorized representative, importer or distributor, warehouse, etc. 

Medical Device Manufacturers 

First of all, the guidance provides additional clarifications regarding the regulatory requirements to be followed by medical device manufacturers based in the country. Apart from complying with the general requirements, they are obliged, inter alia, to:

• Provide proof of compliance to specific provisions of the General Requirements;
• Hire full-time technical managers who are biomedical engineers, technicians or qualified in one of the related fields;
• Hire full-time quality managers who are biomedical engineers, technicians or qualified in one of the related fields;
• Specify the manufacturer’s activity and the level of risk for medical devices that are going to be manufactured. 

According to the guidance, the obligations of medical device manufacturers also include the following ones:

• Ensuring compliance with the requirements in the sphere of medical device Unique Device Identification (UDI) published on the authority’s website;
• Committing to provide after-sale services with respect to the products they are responsible for (for instance, providing spare parts) that are necessary to ensure continued safety and proper performance of medical devices when used for their intended purpose;
• Obtaining a marketing authorization certificate to be issued by the authority before placing any medical device on the market;
• Undertaking full responsibility for the quality of medical devices being manufactured; 
• Performing any and all tests that are reasonably necessary to prove compliance with the respective regulatory requirements in terms of safety, performance, and quality;
• Conducting the abovementioned tests strictly in accordance with the relevant standards;
• Determining the class of a medical device in question under the existing risk-based classification rules for medical devices;
• Ensuring compliance with additional requirements for home use or implantable products. 

Authorized Representatives 

The scope of the guidance also covers the aspects related to obligations and responsibilities of authorized representatives acting on behalf of and in the interest of foreign medical device manufacturers interested in placing their products on the country’s market. 

Specific requirements they should comply with include, inter alia, the following ones: 

• To demonstrate compliance with specific provisions of the General Requirements;
• To be present in the country;
• To obtain a separate license for each entity that has been represented;
• To ensure there is no other authorized representative has been appointed for the same class or general group of medical devices;
• To duly document all the processes subject to record-keeping requirements;
• To have a valid agreement with the medical device manufacturer (in line with the requirements set forth by the national legislation).

As further explained by the SFDA, the aforementioned agreement to be concluded between the foreign medical device manufacturer and its authorized representative should contain the following information and elements: 

• Details about the activities an authorized representative is entitled to undertake;
• Indication of a type of group of products to be placed on the market;
• Undertaking of an authorized representative to comply with any and all requirements in the sphere of post-marketing surveillance;
• Indication of the term of the agreement. 

With respect to the latter, the authority states that the manufacturer should be entitled to terminate the agreement by providing written notice. In such a case, a new authorized representative should be duly appointed, and all the rights and obligations should be transferred from the previous authorized representative to the new one, while the authority should be notified accordingly. At the same time, an authorized representative is also entitled to terminate the agreement by providing written notice to the manufacturer. 

According to the guidance, the obligations of an authorized representative of a foreign medical device manufacturer include:

• Ensuring the continued accuracy and validity of the information related to the medical device in question, as well as notifying the authority about any changes thereto;
• Acting on behalf of and in the interest of the manufacturer in all interactions with the authority;
• Cooperating with the authority in post-marketing surveillance activities;
• Promptly notifying the authority about any incidents associated with medical devices placed on the market, providing explanations and additional details of the actions taken in this respect;
• Informing the authority about the results of corrective actions undertaken, as well as providing a valid justification for such actions;
• Submitting proof of completion of corrective actions taken to ensure the safety of medical devices placed on the market; 
• Duly identifying the risks associated with medical devices allowed for marketing and used in the country.

It is also important to mention that according to the guidance, the responsibility of authorized representative towards medical devices covered in the agreement shall not elapse upon their request to terminate the agreement, unless the manufacturer appoints another authorized representative to replace them, or if medical devices are not available on the market and among the users. 

In summary, the present SFDA guidance provides additional recommendations regarding certain specific regulatory requirements to be followed by the parties involved in operations with medical devices marketed in the country. The document describes in detail the obligations and responsibilities of domestic medical device manufacturers and authorized representatives of foreign ones. 

Sources:

https://sfda.gov.sa/sites/default/files/2023-03/RequirementsLicensingMDEstablishments_0.pdf 

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