Medical Devices

8 New Additions to CDSCO’s List of Regulated Medical Devices

March 13, 2019 Medical Devices, Regulatory Affairs

Do you know? Out of 5000 types of medical devices marketed in India, only 23 types are currently regulated by the Central Drugs Standards Control Organization (CDSCO).

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Spinal Implantable Medical Devices Decode TGA’s Proposal for Reclassification

March 11, 2019 Medical Devices

Australia’s Therapeutic Goods Administration (TGA) published a consultation paper on 11th February 2019 to receive effective feedback from the industry regarding the proposal of reclassifying spinal implantable medical devices to a higher level of classification.

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510(k) Clearances and A Pathway On Safety and Performance

March 7, 2019 Medical Devices

Did you know? The US Food and Drug Administration (FDA) has set yet another high record by approving 106 novel devices in 2018, making it the most successful year for medical devices. With this accomplishment, FDA has surpassed its 40-year old record set in 2017 of approving 99 novel devices, showing a continuous growth for the past 8 years.

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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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IVD Clinical Trials in China – Is an Update on The Way?

January 31, 2019 Medical Devices, Regulatory Intelligence, Regulatory Affairs

National Medical Products Administration (NMPA), formerly known as China Food and Drug Administration (CFDA), is all set to impose stricter regulations on auditing and reinforcement of clinical trials. To ensure best practices for in vitro diagnostic device (IVD), the agency released “Draft IVD Clinical Trial Guideline for Feedback” on November 22, 2018.

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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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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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