Latest news

The importance of quality in healthcare does not need emphasis during a pandemic. But what is needed to ensure that medical devices and equipment are of high quality and safe - especially with supply chains that cross borders? This was the topic of a presentation by GPQI-India at a panel discussion on 6 October.

Standardisation plays an important role in ensuring the safety and reliability of medical devices and equipment. The corona pandemic underlines how important quality aspects in this field are. It also shows the relevance of international harmonisation.

Laboratory testing

The recently published 2020-2024 Sectorial Program of the Mexican Health Ministry presents the identified need for restructuring COFEPRIS, the decentralized agency responsible for protecting the public health, in order to optimise its processes to strengthen transparency.

In light of the COVID-19 pandemic and the current lockdown, India's Central Drugs Standard Control Organization has announced to issue import licences for medical devices and in-vitro diagnostic kits, even if the required notarised documents cannot be presented at the moment.

The Indian Ministry of Health and Family Welfare has announced that all medical devices in India will be notified as drugs and regulated under the Drugs and Cosmetics Act of 1940 effective 1 April 2020.

On 24 September 2019, German Federal Ministry for Economic Affairs and Energy (BMWi) and the National Medical Products Administration of China (NMPA) held a joint workshop on current regulatory topics for medical devices in Suzhou, China. As part of the Sino-German cooperation on Quality Infrastructure, the event provided a platform for dialogue and direct exchange between German authorities and industry representatives with Chinese regulators.

To top