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After a delayed start, Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the 'Medical Devices Regulations') have applied for some time now, [...]

In Short The Situation: While generative artificial intelligence ('GenAI') has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug [...]

The Turkish Pharmaceuticals and Medical Devices Authority ('TİTCK') recently published the Announcement on Operations Under the Regulation on Testing, Control and Calibration of Medical Devices and the Regulation on Market [...]

The 12th Development Plan 2024-2028 ('Development Plan') and the 2025 Presidential Annual Program ('Program') set the development goals and strategic policies for various sectors in Türkiye. In line with the [...]

The European Commission has opened the floor for a discussion on whether the EU medical devices legislation is effective, efficient, relevant, coherent and valuable. The Commission aims to assess the [...]

Headlines that Matter for Companies and Executives in RegulatedIndustries Seventh Circuit Considers When Legal Marketing Transforms Into Illegal Kickbacks On December 4, the US Court of Appeals for the Seventh [...]

Related Advisories/Arnold & Porter Events: Webinar, FDA's New LDT Rule: What You Need to Know, April 30, 2024. Advisory, FDA Intends To Regulate Many Clinical Labs as Medical Device Manufacturers: [...]

Introduction Welcome to the September 2024 edition of our Life Sciences and Healthcare Newsletter, where we delve into the latest developments shaping the industry. This month, we explore a range [...]

On November 28, 2024, China's National Medical Products Administration (NMPA, 国家药品监督管理局), China's equivalent of the U.S. Food and Drug Administration, issued the Draft Administrative Measures for Management of Medical Representatives [...]

The European Commission ('Commission') has published a Questions & Answers ('Q&A') document on the new obligation to notify interruptions or discontinuations of the supply of medical devices under the Medical [...]

Health Canada is currently soliciting feedback on their proposal to amend the Medical Devices Regulations (Regulations), with the intention of modernizing the import and sale of medical devices. The consultation [...]

Mumbai: POLY MEDICURE LTD. - 531768 - Announcement under Regulation 30 (LODR)-Earnings Call Transcript The complete document can be viewed at this link: [...]

'An open foe may prove a curse, but a pretended friend is worse.' When the poet John Gay wrote these words in 1727, the idea of an administrative agency like [...]

In most instances, it is clear if a product will be considered a 'device' under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Sometimes, though, the question of classification [...]

FDA extends the use of predetermined change control plans beyond AI/ML devices The Food and Drug Administration recently issued new draft guidance, Predetermined Change Control Plans for Medical Devices, that [...]

Preemption is one of our favorite topics, not only because it is a powerful defense, but also because the intricacies of preemption and its many flavors make it inherently interesting-at [...]

In Short You must have a New Zealand-based sponsor to sell medical devices. All medical devices must comply with safety and record-keeping requirements. The Consumer Guarantees Act ensures devices meet [...]

On September 12, 2024, the Pharmaceutical and Medical Device System Subcommittee (the 'Subcommittee') of the Japanese Ministry of Health, Labor and Welfare ('MHLW') convened and established a discussion timeline for [...]

Byline: Joe Gorchow (WFOR) -- Click here for updates on this story MIAMI (WFOR) -- The aftermath of recent hurricanes, particularly Hurricane Helene, has extended far beyond the Southeast, with [...]

Rabat: Competition Council of Morocco has issued the following news release: In accordance with Article 13 of Law No. 104-12 relating to freedom of prices and competition and Article 10 [...]

SAN FRANCISCO: A class action lawsuit has been filed against DexCom, Inc., alleging that the medical device company made misleading statements about its financial performance and growth prospects. Hagens Berman [...]

Washington: The United States Nuclear Regulatory Commission has issued the following document: UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 September 13, 2024 ATTN: Radiation Safety Officer Siemens Medical Solutions [...]

When you represent medical device manufacturers in product liability litigation, you will deal with allegations that a device broke or failed because of what it was made from, and you [...]

Mumbai: Dear Sir/Madam, Pursuant to Regulation 30 and 47 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 (The 'SEBI Listing Regulations'), We enclose herewith copies of the newspaper advertisements [...]

Introduction As we progress through 2024, the Turkish healthcare sector continues to evolve rapidly, with numerous legislative changes affecting various aspects of the industry. At Lexin Legal, we understand the [...]

Mumbai: POLY MEDICURE LTD. - 531768 - Announcement under Regulation 30 (LODR)-Meeting Updates The complete document can be viewed at this link: [...]

Key Takeaways The U.S. Food and Drug Administration (FDA) recently published a Discussion Paper which outlines a potential framework for future guidance and regulations regarding the clinical evaluation of medical [...]

In today's digital age where misinformation can spread rapidly and widely via internet-based channels, the U.S. Food and Drug Administration (FDA) has taken a significant step toward ensuring that accurate [...]

On this episode of Non-binding Guidance, hear from Kellie Combs, chair of Ropes & Gray's life sciences regulatory and compliance practice group, and Josh Oyster, a nationally recognized partner in [...]

Lack of Medical Device Regulation certification means some legacy devices could be pulled from the EU market Thousands of medical device manufacturers have not achieved certification of their products under [...]

Mumbai: Pursuant to Regulation 47 read with Regulation 30 of the SEBI(Listing Obligations and Disclosure Requirements) Regulations, 2015, please find enclosed herewith the copies of the newspaper publication of postal [...]

With the rapid advancement in medtech, medical devices have been made increasingly based on additive manufacturing techniques. According to GlobalData, a leading data and analytics company, 3D printing in medical [...]

On June 26, 2024, the U.S. Food and Drug Administration ('FDA') released its much-anticipated draft guidance for industry entitled 'Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations [...]

The California Supreme Court has recognized a new path for plaintiffs to prove causation in failure-to-warn cases against manufacturers of prescription drugs and medical devices. Under the learned intermediary doctrine, [...]

On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration's final rule concerning the [...]

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter [...]

On May 6, 2024, the Food and Drug Administration (FDA) issued its long-anticipated final rule regulating laboratory developed tests (LDTs). For approximately two decades, the FDA has been signaling its [...]

Mumbai: Pursuant to the Regulation 40(9) of SEBI(Listing Obligations and Disclosure Requirements) Regulations, 2015, Please find attached the certificate issued by the Practicing Company Secretary for the financial year ended [...]

Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts and sales [...]

Mumbai: POLY MEDICURE LTD.has informed BSE that the meeting of the Board of Directors of the Company is scheduled on 08/03/2024 ,inter alia, to consider and approve We wish to [...]

The National Agency for Food and Drug Administration and Control (NAFDAC) is the key body in Nigeria regulating the registration of drugs, medical devices, food supplements, and cosmetic products. For [...]

Mumbai: Dear Sir/Madam, Pursuant to the provisions of Regulation 30 and 46(2)(oa) of the securities and Exchange Board of India (Listing Obligation and Disclosure Requirements) Regulations, 2015, as amended, the [...]

On January 3, 2024, the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) (the 'Amended Regulations') came into force. They were accompanied by new [...]

Background The Drugs, Medical Devices and Cosmetics Bill, 2023 (the 'Drugs Bill') seeks to replace the Drugs and Cosmetics Act, 1940 (the 'Drugs Act') as the law governing the manufacture, [...]

Rabat: Competition Council of Morocco has issued the following news release: In accordance with article 13 of law 104-12 relating to freedom of prices and competition and article 10 of [...]