Medical Devices

Manufacturing Site Change Supplement Decode the USFDA’s Final Guidance

June 25, 2019 Compliance, Audit and Validation, Medical Devices, Publishing & Submissions

In December 2018, the United States Food and Drug Administration (US FDA) published the final guidance on Manufacturing Site Change Supplements: Content and Submission. Replacing the 2015 draft guidance, the final guidance clarifies the responsibilities of medical device manufacturers who are willing to change their manufacturing site for an approved device.

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CDSCO Classifies 12 Newly Notified Medical Devices

May 30, 2019 Medical Devices, Regulatory Affairs

On May 15, 2019, Central Drugs Standard Control Organization (CDSCO) of India has published a notification regarding the classification of new devices, which are notified for regulation. As per the notification, the newly regulated medical and in vitro diagnostic (IVD) devices will be classified as per the provisions of Medical Device Rules – 2017.

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3-Part Strategy of Health Canada’s Medical Device Action Plan

February 20, 2019 Medical Devices

Health Canada (HC) has one of the most stringent regulations for medical devices. To further increase the safety and effectiveness of devices, and optimize the health outcomes for end-users, the Canadian health authority (HA) is aiming to strengthen the current Regulatory framework. The three-part strategy announced recently as an action plan is the part of the same.

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Artificial Intelligence in Life Sciences
Decode USFDA’s Pilot Programs

February 14, 2019 Medical Devices, Pharmaceutical, Regulatory Affairs

Artificial Intelligence (AI) is paving the way for innovative medicinal products and advanced medical devices. It is gradually headed towards decreasing repetitions in clinical trials, increasing the accuracy in drug designing processes and disease identification, personalization of patient diagnosis etc.

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TGA’s Draft Guidance for Medical Device Cyber Security - Regulatory Insights for Industry & Highlights

January 28, 2019 Medical Devices, Regulatory Affairs

Although digitization and Internet of Things (IoT) have together enhanced the performance of medical devices, they have also made devices prone to cyber vulnerabilities. The malware and spyware invading the devices are growing. The hackers are mining for loopholes in devices and related software that allow them to corrupt the devices to compromise user data by malfunctioning the devices.

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Regulatory Medical Writing - How Can You Be Meticulous?

January 22, 2019 Regulatory Affairs, Regulatory Medical Writing

While researching for an innovative drug/device/cosmetic/food supplement, a huge amount of clinical data is expected to be generated. The conclusions of such data must be clearly reported with an appropriate level of detail to the health authorities (HAs). The information to be reported or documented might be research data, trial descriptions, findings, warnings etc.

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2019 and Farther – A Regulatory Heads-up

January 7, 2019 Medical Devices, Nutraceuticals/Food Supplements, Pharmaceutical, Regulatory Affairs

With each year, Life Sciences industry is transforming in unpredictable ways, of course it is to better the end-user’s safety. The industry is progressing with technological advancements and the health authorities are equally striving to upgrade the existing Regulatory frameworks to align with market requirements.

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Throwback 2018 – The Regulatory Summary in a Nutshell

December 27, 2018 Artwork Pack Management, Compliance, Audit and Validation, Consumer Healthcare, Cosmetics Regulatory Services, Medical Devices, Nutraceuticals/Food Supplements, Pharmaceutical, Registration Strategy, Regulatory Intelligence, Regulatory Labeling, Regulatory Software & Services, Regulatory Affairs, Market Access, Regulatory Consulting, Publishing & Submissions, Regulatory Medical Writing, Health Authority Updates

The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.

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FDA’s 510(k) Clearance Pathway – Is an Update on The Cards?

December 20, 2018 Medical Devices, Regulatory Affairs, Publishing & Submissions

Every year, FDA regulates more than 190,000 medical devices pertaining to different classes. In order to provide better healthcare, the agency is striving continuously to update the pathways through which these devices are being submitted. In a recent press release, FDA announced that the agency is looking at the potential aspects to update the 510(k)-clearance pathway for medical devices.

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Clinical Evaluation Report: Get the Basics Right

November 26, 2018 Medical Devices, Regulatory Affairs

A Clinical Evaluation Report (CER) is a safety and performance assessment report of any medical device based on the clinical data related to it. The clinical data is either collected through clinical investigation or by availing previously collected data of a substantially equivalent device.

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