Intending to curb the spread of COVID-19, the MHRA extended the free PPE (Personal Protective Equipment) scheme, which was initially introduced in March 2020. The scheme intends to protect the health and social care providers, and community pharmacies, and public sector organizations from COVID-19, by providing easy access to PPE in the volume required.
Health Canada has clarified its stand on the research use only testing kits related to COVID-19. Health Canada regulates the import and sale of medical devices and IVDs (In-vitro Diagnostic Devices) in the Canadian market. In the event of the ongoing COVID-19 pandemic and to facilitate the supply of essential medical devices and IVDs, Health Canada has released various Interim Orders for the manufacturers, importers and distributors.
Since the onset of Coronavirus Disease 2019 (COVID-19), Health and Human Services (HHS) has declared a Public Health Emergency. The US FDA, since then, has been releasing various enforcement policies to ensure continued supply of certain essential medical devices, which play a vital role in prevention, diagnosis, management and treatment of COVID-19 and associated co-morbidities. A new enforcement policy has been released by the US FDA to facilitate the increased supply of coagulation systems used for assessing the viscoelastic properties of whole blood and the hemostasis in patients.
Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.
The US FDA continues to release and update the guidelines and enforcement policies for efficient management of the device Regulatory affairs in the USA, alongside handling the emergency health situation that surfaced due to the COVID-19 pandemic.
The Mexican Regulatory Authority, COFEPRIS (The Federal Commission for Protection against Sanitary Risk) has established a new electronic appointment system for medical device registrants for submitting applications or seeking in-person meetings with the Agency. This measure is a part of the digitization process and in compliance with the provisions of the Ministry of Health, to limit the number of visitors to the COFEPRIS facilities and reduce the risk of contagion by COVID-19.
Couple of months back we thoroughly discussed about FDA’s expedited Regulatory pathways during medical emergencies. In that specific explanation as we listed the FDA’s tools and programs for expedited approvals with respect to review and approval of therapies, including biologics, this time we would like to bring the same perspective in relation to medical devices.
Amidst the Covid-19 pandemic, the demand for surgical apparel (including gowns, gloves, togas and other apparel) has increased drastically. But on the other side, supply chains are going down with minimal production. Therefore, to increase the availability of these products in need, the United States Food and Drugs Administration (US FDA) has released a guidance document addressing urgent public health concerns. The guidance is intended to remain in effect only during the public health emergency of Covid-19.
With the continual rise of COVID-19 cases, the healthcare facilities are witnessing shortage of respirators. Assessing the critical shortage and enormous demand for respirators, the global Regulatory agencies are swiftly initiating significant efforts to develop practical methods for decontaminating used respirators effectively. Accordingly, Singapore’s Health Sciences Authority (HSA) has issued guidance on facilitating access to safe and effective medical devices, intended for decontaminating used respirators through provisional authorization pathway.
The use of face masks is increasing due to the rapid spread of COVID-19. To meet the growing demand, different types of face masks are manufactured and released into the market, claiming to serve the medical purpose. To be precise, the European Commission (EC) has clearly defined the medical face masks and proposed Regulatory options to place them in the EU market with short-term supply feasibility.
