In India, a medical device test license, issued by the Central Drugs Standard Control Organization (CDSCO), is a temporary license that allows a manufacturer to conduct tests on their medical device before they can obtain a permanent license for it. The test license allows the manufacturer to conduct clinical trials and other tests on the device and gather data on its safety and efficacy. The CDSCO requires the manufacturer to obtain this license to ensure that the device is safe and effective for patients’ use.
Electronic Labeling (e-labeling) is a medical device labeling alternative to traditional paper labeling. It entails the use of electronic media such as CD-ROMs, DVDs, or websites to provide consumers/users with label information. There are numerous benefits of e-labeling in the medical device industry. The most significant advantages are the following:
The Unique Device Identification (UDI) system is an international standard that assigns a unique code to each medical device to improve patient safety and streamline product tracking and recall. In China, the National Medical Products Administration (NMPA) has implemented UDI guidelines and regulations for medical devices to enhance safety and quality control.
Custom-made medical devices in Australia are regulated by the Therapeutic Goods Administration (TGA). The TGA has changed the way of regulating custom-made medical devices in Australia, and the changes affect anyone who is manufacturing, importing, or supplying custom-made medical devices, including healthcare providers.
According to the Therapeutic Goods (Medical Devices) Regulations, 2002, a custom-made medical device is defined in the following terms:
Label maintenance and updating is the process of ensuring that the data on the label stays up-to-date and accurate throughout the life cycle of the device. This could entail updating information to meet new laws or standards, amending the existing labels to reflect changes in the product or its intended use, or fixing typographical errors.
ANVISA comes up with a new resolution, RDC 751, effective from March 01, 2023. The Resolution defines the risk classification rules for medical devices, labeling requirements and Instructions For Use (IFU), and the procedures for notification, registration, amendment, revalidation, and cancellation of notification or registration of medical devices. It revokes RDC no. 185/2001, RDC no.15/2014, and RDC no. 40/2015. Here is the gist of the latest Brazilian regulation.
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.