Recently, the FDA published three (03) guidance documents that focus on generic drug application submissions, labeling, and review. Among the three (03) guidance documents, two (02) are final drafts, and one (01) is a revised draft, which supports FDA’s Drug Competition Action Plan (DCAP) that was first announced in 2017. The guidance documents are a part of the FDA’s continued effort to bring greater efficiency and transparency to the generic drug review process, which helps spur competition and improves consumer access to medicines at affordable prices. Let’s dive into the details.

With technological advancements, the adoption of wireless medical devices for patients and healthcare management is growing at a fast pace. It is anticipated that four (04) out of ten (10) medical devices installation will be wireless or portable by 2031, and the wireless portable medical device market is expected to reach USD 33 billion. The wireless medical devices utilize radiofrequency communication such as wi-fi, Bluetooth, cellular or mobile phones. Interoperability is the key feature of these technologies, and all the related concerns are applicable.

With the dynamic landscape and the new reality due to the pandemic, the chemical industry has undergone a huge shift in demand. In the chemical market, the end of life for certain materials can start something new. Implementing a series of targeted, strategic initiatives across major functional areas can help manufacturers cater to short term demands. However, focusing on the short term does not necessarily mean neglecting long-term opportunities. Manufacturers must generate sustained growth by investing in innovation, emerging applications, and adopting new business models.

The Health Ministry of Thailand strives to maintain the optimum quality of life and takes all the necessary measures to assure the health and safety of its people. Recently, the TFDA has amended the medical device regulations to meet the highest safety standards and quality of devices entering the Thailand market. The device labeling is a critical communication channel that educates the end-user and patient about safety, efficacy, and instructions for using a given device.

Communication effectiveness across the marketing platforms is evaluated primarily based on how well the content engages the audience or, in the case of brands, the consumer. In healthcare, the information available on these platforms is diverse. There are many variations to multiple content types therefore, such boundless volume of content and technical terms may overwhelm the audience with information.

Labeling has paramount importance in the medical device industry for ensuring high standards of quality and safety. The labels help educate the end-users or patients about how to use the device, who should use it, how to operate the device safely and what risks it could pose. Therefore, medical device manufacturers must gain a clear understanding and comply with the updated Health Authorities labeling regulations.

It is well known that the mandatory deadline for European Medical Device Regulation (EU MDR) was postponed to May 26, 2021, due to abrupt onset of COVID-19. In simple terms, the EU MDR aims to provide device clinical safety and effectiveness by establishing a robust, transparent and sustainable Regulatory framework that is recognized internationally and improves fair market access for manufacturers. 

Determining and setting up a quality system is a challenging task for medical devices manufacturers. A robust quality system covers the aspects like the medical device design, manufacturing, supplier management, product labeling, storage & distribution, clinical data, risk management and complaint handling. The US FDA maintains a Quality System Regulation (QSR), which ensures that all the medical devices sold in the USA are safe, quality-oriented and effective for their intended use.

With the EU MDR (European Union Medical Device Regulation) deadline inching closer on May 26^th, 2021, it is necessary for the device industry to be aware of the EU MDR 2017/745 regulation for Economic Operators (EOs). As per the regulation, a Manufacturer, an Importer, a Distributor, and an Authorized Representative (AR) are considered as Economic Operators (EOs). With an aim to enhance safety and efficacy of the medical devices entering the EU market, the EU MDR regulation has laid down stringent requirements for EOs.  

As the EU MDR transition deadline is inching closer, manufacturers must execute the labeling requirements with utmost priority and caution and must ensure high standards of quality, and safety for compliance. Prior to execution, understanding the new labeling requirements and accurate implementation is of paramount importance. Any labeling errors can impede the progress, cause product recalls and lead to costly delays.

Therefore, the key is to carefully prepare the medical devices labels aligning with the EU MDR labeling requirements, such as: