- Health Canada is evaluating Zentek's ZenGUARD™ Enhanced Air Filters' regulatory classification and has requested more information.
- Zentek (ZTEK, Financial) withdrew its initial PMRA submission to pursue an alternate commercialization strategy.
- Zentek plans to market ZenGUARD™ Filters as a Class I medical device under its Medical Device Establishment License.
Zentek Ltd. (ZTEK) has announced a regulatory update concerning its ZenGUARD™ Enhanced Air Filters in Canada. Health Canada, the department responsible for national public health, is currently assessing the classification of this product and has asked Zentek for additional information to aid in the regulatory process.
Originally, Zentek had submitted its ZenGUARD™ Enhanced Air Filters for evaluation by the Health Canada Pest Management Regulatory Agency (PMRA) under the Pest Control Products Act. However, on October 31, 2024, the company decided to withdraw from this submission process to explore a different pathway for commercialization. Following this, on November 27, 2024, Zentek announced its intention to market the air filters as a Class I medical device, leveraging its existing Medical Device Establishment License (MDEL), a strategy similar to that used for its surgical masks.
Zentek is an intellectual property technology development and commercialization company based in Guelph, Ontario. It focuses on enhancing partners' products to make them safer and more efficient, with initiatives like the ZenGUARD™ technology platform aimed at increasing filtration efficiency.
