Coronavirus: NAFDAC Grants Emergency Use Approval of Medical Devices

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The National Agency for Food and Drug Administration and Control (NAFDAC) has issued conditional approval for the use of medical devices required to impact positively on public health outcomes, in the current battle against the ÇOVID-19 pandemic.

It listed the medical devices covered by the emergency use approval as follows: COVID-19 antibody, antigen test kits, and personal protective equipments,PPEs.

 

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The agency gave guidelines for the conditional use of the devices, noting that the antibody test kits (IgG/IgM) can be used in COVID-19 confirmed individuals, who can then be tested at the designated centres using the antibody kits, to confirm that they have antibodies and as such may not be infected again. The antigen tests kits on the other hand, can detect the COVID-19 antigen in patients with or without symptoms. The results are only qualitative (positive or negative).

Speaking through a press statement made available to Pharmanewsonline, the NAFDAC DG, Prof. Moji Adeyeye, disclosed that the current condition of COVID-19 in the country, compelled the agency to take some drastic steps in regulating the use of medical devices for easy diagnosis of the virus.
She said: “NAFDAC, in pursuant to the powers conferred on it by section 5 of the NAFDAC Act, to regulate and control the manufacture, importation, exportation distribution sale, use and advertisement of medical devices, has taken some regulatory steps in the fight against COVID-19.

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“The current COVID-19 pandemic has necessitated that NAFDAC put measures in place to ensure access to health commodities that have the potential to impact positively on public health outcomes. These include, but are not limited to, diagnostics necessary to support public health infrastructure and guide the response necessary to combat and address the pandemic.

“There has been a global effort by innovative diagnostic companies to develop test kits to aid in detection of the virus in patients to guide the management of the disease. The Agency has recently received many requests for Emergency Use Authorization for some of such diagnostic test kits to support the national response and ensure expanded testing capabilities”.

In addition to this conditional approval, she however cautioned that full approval of any diagnostic/test kit by NAFDAC for COVID-19 will be subject to in-country validation to assess the sensitivity or rate of failure (i.e., indication of false positives), and specificity.

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Failure to comply could lead to revocation of any approval granted for importation of the products and forfeiture of same to the agency for destruction, she averred.

Adeyeye also disclosed that NAFDAC has put in place regulatory measures to ensure quality, safety and efficacy criteria are assessed.
These measures are supported by documentation which include the following:

Prior registration and approval by reference regulatory authorities such as those of Japan, USA, Germany, Canada, European Medicine Agency, etc.

Registration by the regulatory authority in the country of manufacture; and declaration of conformity and validation/performance evaluation /clinical evaluation report.

The statement reads in part:

“NAFDAC will continue to stay abreast of current best global practices in this area and monitor updates to the WHO collated list of medical devices being used by different countries.

“NAFDAC has reduced the “registration to approval” time from 120 working days to 10 working days due to the COVID-19 pandemic. Thus far, the agency has processed seventeen (17) applications using the expedited review process but has only granted Emergency approval to seven (7) companies using the criteria listed above.

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“The availability of Personal Protective Equipment (PPE) for healthcare providers is a critical component of the effort to stem the COVID-19 pandemic. These PPEs include gloves, protective goggles, face shields, protective gowns and masks in the form of particulate respirators and surgical masks. These must meet certain technical requirements and specifications in order to achieve the objective and offer some measure of protection to health care providers and limit their exposure to infection .

“Please note, no vaccine has been approved for any clinical trial. That may not happen before one year to eighteen months, after clinical trials must have been conducted in different countries. This will be followed by rigorous in-country assessment in line with laid down protocols to further ensure safety and efficacy”.

 

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