Published: March 2023
The Saudi Food and Drug Authority (“SFDA”) issued a guidance document on 8 January 2023 to define and clarify the requirements for manufacturing medical devices at points of care (“POC”) in KSA (“Guideline”). In general, medical devices cannot be marketed or used in KSA unless they are registered and have a Medical Device Marketing Authorization (“MDMA”) from the SFDA. The SFDA issued this Guideline to exempt POC medical devices from the requirement to obtain an MDMA, and it replaces SFDA’s earlier document, Guidance on Patient-matched Medical Devices Using 3D Printers (MDS-G30).
What is POC Manufacturing?
Manufacturing of a POC medical device by healthcare facilities in the Kingdom, which may include:
- Putting together of a device from raw materials or component parts;
- The complete rebuilding of an existing device; or
- Device software development (including AI)
What are the types of activities are covered?
This Guidance applies to healthcare providers wishing to manufacture POC medical devices within their facilities for their own use and for non-industrial scale (with regard to the magnitude and methods of production), and applies to the following activities:
- Manufacturing of medical devices using 3D printer inside a healthcare facility;
- Manufacturing according to the Medical Device Production System (“MDPS”);
- In-House IVD; and
- All medical devices modified or developed within a healthcare facility.
Medical-grade raw materials must be used and MDMA must be obtained for the software used for printing the medical device, in accordance with the SFDA Requirements for Medical Devices Marketing Authorization (MDS-REQ 1).
Further, the healthcare facility must provide and document information to the SFDA about the 3D printers, including maintenance records. In relation to the MDPS, the healthcare facility must provide and document the MDPS file, which includes information about raw materials, software, equipment, final product, intended use and users.
The requirements below are applicable to all in-house IVDs including:
- In-house IVD test developed from first principles;
- IVD test developed or modified from a published source; and
- Modifications to commercially supplied IVDs.
The healthcare facility must develop/modify and conduct the IVD test for the own use inside the healthcare facility and provide and document information about the IVD test that is intended to be developed or modified.
Guidance is also provided on implantable medical devices.
What are the general requirements?
The healthcare facility must submit to the SFDA an Application Form for POC Medical Devices Manufacturing, which includes:
- Providing a justification for M=manufacturing at the POC rather than purchasing medical devices available in the market. Such a justification shall clearly include patients’ needs, lead-time, accessibly, cost, or flexibility on the medical device’s design;
- Declaring that it is manufacturing POC medical devices inside the healthcare facility for its own use and not transferring them to another facility; and
- Details concerning the manufacturing process including document confirming the devices is manufactured in accordance with the requirements of Medical Devices Quality Management System (ISO 13485).
Will the POC medical devices be subject to a post-market surveillance?
Yes, it is required that the healthcare facility:
- Implement a surveillance system to gather experience from the clinical use of the device;
- Track the medical device throughout its lifecycle;
- Conduct preventative and corrective actions to ensure the safety of patients and users of the medical device;
- Report all incidents, adverse events, and complaints to the MCMDR in accordance with the SFDA Requirements for post-market surveillance of - Medical Devices (MDS-REQ 11)
How Al Tamimi & Company can help?
For more information, please contact our Healthcare & Life Sciences sector group, which operates across the region, including in our three Saudi Arabia offices, advising a wide range of healthcare and life sciences clients on entering or operating in the Kingdom.
Key Contacts
Christina Sochacki
Senior Counsel
c.sochacki@tamimi.com