COVID-19 outbreak triggers Medical devices regulatory interventions in SFDA

3/14/2020
 

​Due to the outbreak of COVID-19, The Saudi Food and Drug Authority (SFDA) has taken steps to ease importing restrictions, accelerate registration processes and provide all support for local factories and distributing companies to ensure regulations do not block the development or supply of devices that could save lives. 

In order to ensure an adequate supply of medical devices and products needed are available in the kingdom, the following new regulatory interventions were applied:

Importing Personal Protective Equipment (PPE)

  • SFDA expedited the evaluation process and issuing the medical devices marketing authorization (MDMA) for the medical Personal Protective Equipment (PPE) such as medical masks, medical gloves, and single-use protective clothing to be within two working days after ensuring their safety.
  • The distributing companies can be provided with temporary importing license until completing their registration through MDMA
  • N95 industrial masks can be used by health care providers in emergency cases, when the medical masks are not available.

Local unauthorized factories for Personal Protective Equipment (PPE)

  • Organizing an audit visit by SFDA representative team to ensure safety and quality of raw materials and overall manufacturing processes. If the safety and quality of the manufacturing processes were accepted, a temporary permission will be provided during the urgent crisis period.
  • The manufacturers shall register later with SFDA and fulfill all manufacturing requirements including ISO 13485 from accredited organizations.

Emergency Importing permission for IVD kits

  • The SFDA is issuing an emergency approval and importing permission for IVD kits (for research use) specifically used for the diagnosis of Corona virus (COVID-2019).