The Saudi Food and Drug Authority (SFDA) of Saudi Arabia has published guidance for local medical device manufacturers intended to provide additional clarifications and recommendations. The scope of the guidance covers aspects such as preparation for applying for marketing authorization, the application process itself, and activities to be carried out by the local manufacturer when the marketing authorization has been received. The SFDA has already issued similar guidance documents for overseas manufacturers and authorized representatives.
Preparing for Medical Device Marketing Authorization
The SFDA emphasizes that under the applicable legalization, the medical device manufacturers based in the Kingdom of Saudi Arabia, as well as other parties involved in operations with medical devices (including authorized representatives, importers, and distributors) are obliged to register with the authority. At the same time, in the case of a local medical device manufacturer, the whole scope of activities usually performed by the importer and/or distributor could be carried out by the manufacturer itself.
Before commencing its activity related to medical devices, the interested party shall:
- Submit information for registration purposes.
- Provide the required medical device listing information to the Medical Devices National Registry (MDNR).
According to the guidance, the medical device manufacturer shall be solely responsible for maintaining the information provided to the SFDA up-to-date. In this regard, the manufacturer shall duly inform the regulating authority about any significant changes no later than 10 calendar days from the date such changes took place.
Upon registration, each entity involved in operations with medical devices would be assigned with its National Registry Number.
The process of establishment registration does not depend on the class of medical devices manufactured by the establishment under the risk-based classification. In order to apply for registration, an interested establishment shall submit the appropriate electronic application form. In particular, an establishment applying for registration shall provide the regulating authority with the following information:
- The indication of the role the applicant establishment intends to take (e.g. local manufacturer, importer, etc.), and also the detailed description of the activity the establishment intends to perform in Saudi Arabia.
- The name and contact details of the applicant establishment and it’s representative responsible for the registration, including the physical address, phone number, and email address.
- An indication of whether the information provided is entirely new or constitutes an update to the information already entered into the registry. In the latter case, the applicant establishment shall also indicate its National Registry Number in order for the SFDA to be able to associate the newly submitted information with an existing entry in the register.
- The date of submission.
Thus, any and all local medical device manufacturers should be duly registered with the SFDA and assigned with the Establishment National Registry Numbers. The appropriate application could be submitted online via the Medical Device National Registry (MDNR), the country’s official registry. The information provided in the electronic application form should be complete and accurate. The local manufacturer may use the same form and procedure to update the information within the timelines described hereabove. In certain cases, the regulating authority may also ask the local medical device manufacturer to explicitly confirm that all the information entered in the register is relevant and up-to-date.
It is also important to mention that in case if the local medical device manufacturer carries out the distribution activities itself, it shall comply with all applicable requirements for the distributors addressed in the appropriate SFDA guidance. Moreover, under the Medical Devices Interim Regulation, the local manufacturer shall register with the regulating authority only in case it intends to distribute its products in Saudi Arabia.
Applying for Medical Device Marketing Authorization
According to the Medical Devices Interim Regulation, any and all medical devices placed on the market should comply with the applicable requirements and have the appropriate authorization in place. This rule applies for all medical devices and accessories thereto, as well as contact lenses and laser surgical equipment for cosmetic purposes intended to be marketed in Saudi Arabia. The appropriate authorities should be issued by the SFDA as a regulating authority in a written form.
The guidance refers to Article 6 of the Medical Devices Interim Regulation stating that to obtain marketing authorization, medical devices shall comply with the relevant regulatory requirements applicable in one or more of the jurisdictions of Australia, Canada, Japan, the USA, and the EU/EFTA, and additionally with provisions specific to the KSA concerning labeling and conditions of supply and/or use.
There is also a special rule addressing the changes to medical devices. According to the present SFDA guidance, if an establishment makes certain modifications to the medical device, and such modifications could cause an impact on the safety and performance of a medical device, an additional assessment, and approval of the regulating authority would be required before placing modified medical devices on the market. Moreover, an establishment performing such modifications on its own behalf would be considered the medical device manufacturer and consequently obliged to comply with all applicable requirements.
According to the SFDA guidance for local manufacturers, the aforementioned medical device marketing authorization is not required for medical devices intended to be used by the same entity for its own internal purposes (in-house medical devices). This category covers medical devices manufactured by the healthcare institutions themselves and used solely by their personnel, providing that such in-house medical devices are not being transferred to any external third parties.
Another important aspect relates to the accessories to medical devices. In spite of the fact the accessories are not medical devices themselves, the local manufacturers producing them are obliged to apply for authorization in order to be allowed to market them in Saudi Arabia.
Thus, the local medical device manufacturer shall:
- Register with the national register – MDNR,
- Sustain compliance with the applicable requirements set forth in the GHTF Founding Member jurisdictions,
- Achieve and sustain compliance with the local requirements (labeling, storage/installation, advertising).
Activities After Receiving the Medical Device Marketing Authorization
The present SFDA guidance for local manufacturers additionally describes the actions the medical device manufacturer shall take after receiving the medical device marketing authorization. In particular, the local manufacturer shall apply for listing its product with the SFDA. For this purpose, the manufacturer shall submit the appropriate medical device listing information to the MDNR and sustain its validity – in accordance with current regulations, the local manufacturer shall update the listing information related to the medical device no later than 10 calendar days from the date the changes to the device took place.
Upon completion of listing, the SFDA will issue the appropriate listing number to the medical device – the Medical Device National Listing Number. This number should be used in all further communications regarding the device to identify it.
The listing information to be provided by the local manufacturer includes:
- The indication of the number of medical devices to be supplied, their serial or lot numbers, as well as the shipment date and destination,
- The indication of whether the information provided is entirely new or amends existing entries,
- The date of submission.
Summarizing the information provided here above, the SFDA guidance for local manufacturers addresses the most critical aspects to be considered by the local entities involved in manufacturing medical devices intended to be marketed in Saudi Arabia. In particular, the document describes the obligations of the local medical device manufacturers on all steps of the procedure to be performed before placing medical devices on the market.
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