EFDA’s Interim Quick Assessment (IQA) system for Medical devices which are listed as ‘high priority devices’ due to COVID-19

EFDA's quick assessment and approval system for COVID-19 related medical devices

EFDA’s Interim Quick Assessment (IQA) system for Medical devices which are listed as ‘high priority devices’ due to COVID-19

The issue of CoronaVirus Disease (COVID-19) has now become beyond everything else. This is due to the disease’s feature of easy spreading, no enough diagnosis, no known treatment, no enough Personal Preventive Equipment (PPE) across the world. This makes the situation even worse in the countries (eg. Ethiopia) where social distancing and staying at home is not practicable.

If a person can’t stay at home or practice social distancing, it is always advisable to use Personal Protective Equipment especially when he/she has COVID-19 symptoms (dry cough, fever, fatigue and difficulty breathing) or confirmed to be infected by the virus. The availability of these equipment is very low in all countries as the COVID-19 case is an international emergency issue where every human being needs to protect him/herself.

In Ethiopia also, as the country is short of having such important commodity for all its citizens (just like other countries), all Government Authorities and Agencies including Ethiopian Food and Drug Authority (EFDA) are playing their parts harder than ever to help the community get the health products which help protect them from this disease.

Accordingly, EFDA has planned to implement an Interim Quick Assessment (IQA) system for medical devices whose intended uses are to prevent, diagnose or give supportive treatment to COVID-19 positive patients. This assessment system will help ensure quicker and more flexible approval of the importation and sale of products that are necessary for Ethiopia’s response to COVID-19, which are listed below to make them readily accessible in the country:

  1. Medical face masks
  2. Alcohol-based hand Sanitizers
  3. Patient ventilators
  4. Pulse oximeters
  5. Oxygen concentrators
  6. Oxygen cylinders

This Interim system may also help ensure Ethiopian access to other marketed COVID-19-related medical devices used to treat, mitigate or prevent COVID-19, as necessary.

With this Interim system, EFDA could also look to approvals granted by foreign regulatory authorities in deciding whether to approve an application for the importation or sale of COVID-19-related medical devices. Existing devices, where the approved, intended use was not originally COVID-19-related, could also be expanded under this system.

This Interim system is currently the fastest mechanism available to the Government of Ethiopia to help make medical devices available to address larger scale public health emergencies. It provides EFDA with the flexibility to consider the urgent circumstances relating to the need for the medical device, authorizations granted by foreign regulatory authorities, or possible new uses for medical devices that are approved in Ethiopia.

As with all medical devices, EFDA will assess and monitor the safety and effectiveness of the devices accessed under this Interim system once they are on the market, and will take immediate action to protect the health and safety of Ethiopians if necessary.

For the purpose of this Interim Evaluation and Approval for sale and marketing, the Authority has developed device specific requirements for all listed COVID-19 related medical devices.

Accordingly, medical face masks and Sanitizers exempted from regular registration applications and their current approval system depends on the product’s specific simple requirements set by the EFDA and the evaluation and approval period is very quick.

The local companies who are willing to manufacture one of these products are also welcome. EFDA will help them provide a standard document within which the company needs to manufacture and provides fast assessment and approval to authorize the products for marketing in the country.

For other devices (Ventilators, Oxygen Concentrators, Pulse Oximeters,..etc.), the registration application is made as usual and the assessment duration for these devices will be greatly minimized to two to four weeks (from the time of request to approval).

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