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China Widens Entry to Medical Device Market to Investment, Innovation While Tightening Regulations on Existing Market Products

As the medical device industry in China continues accelerated growth, investors seek to capitalize on a roughly $65 billion market that is growing at an annual rate of 21 percent. Under recent changes to the regulatory...more

Africa Update - October 2014 #2

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub-Saharan Africa - General Africa News - Excerpt from Leading the...more

Realizing the Potential of Telemedicine in China, Part 1: Protecting Your IP

This post is the second in Foley’s blogs on China telemedicine and the first in the blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the...more

Lame Duck Preview

With the November elections looming, the House and Senate completed their work last week before departing Washington to campaign, leaving any remaining legislative work for the post-election lame duck session. The brief work...more

Privacy Tuesday – September 2014

Happy autumnal equinox Home Depot Breach – By the Numbers: - 56 million cards at risk (compare to Target = 40 million) - $62 million in estimated costs (compare to Target =$146 million and...more

China Issues New Telemedicine Opinions for China and Foreign-Based Providers

Telemedicine providers and vendors doing business in China, whether based in China, the United States, or elsewhere, received new guidance on the use of telemedicine in China....more

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

China’s NHFPC issues Opinions on Promotion and Administration of Telemedicine Services

In recent years, China’s central government has made substantial investments to support the development of telemedicine. According to statistics from the National Health and Family Planning Commission (NHFPC), there were...more

Health Alert (Australia) - August 18, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Queensland - 25 July 2014 (published 8 August 2014) - Cotterell v Redcliffe Assembly [2014] QCAT 357 - The...more

MoFo BioMeter - Vol. 3, Issue 3, August 2014 - Q2 Biometer Shows Strong Value In Drug Discovery Platforms

The average BioMeter value in the second quarter of 2014 jumped significantly to $143.4 million, an increase from the $15.9 million value in the first quarter. This included two blockbuster deals, the $1 billion up front paid...more

Health Alert (Australia) - July 28, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales (NSW) - 22 July 2014 - Lane v Northern NSW Local Health District (No 3) [2014] NSWCA 233 - This...more

Health Alert (Australia) - July 14, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Commonwealth - 4 July 2014 - Angelos v Minister for Health [2014] FCA 706 - This was an application made to the...more

China’s National Auditing Office Notes Compliance Concerns with Sponsorship of Academic Conferences in the Healthcare Sector

In China, it is common industry practice for pharmaceutical companies to sponsor academic conferences. As long as such events are aimed at enhancing the practice of medicine and patient welfare, the practice has been allowed....more

Snapshot of Sunshine Rules in EU Countries for The Pharmaceutical Industry

Since the enactment of the Physician Payments Sunshine Act (US Sunshine Act) by the United States, a number of EU Member States have adopted similar rules or strengthened pre-existing regulation in order to improve the...more

Singapore: Opportunities for Medical Innovation

In addition to mobile health opportunities in the United States, tremendous potential for growth exists throughout the world, including in Southeast Asia. Singapore in particular is working to become a leader in healthcare...more

Health Alert (Australia) - June 23, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: Queensland. Department of Health: - 18 June 2014 - Public patients get private sector boost. Thousands of public patients...more

China Amends Key Medical Device Regulations

The State Council of China passed amendments to the Regulations on Supervision and Administration of Medical Devices which came into effect on June 1, 2014. The amendments present significant regulatory changes that will...more

Health Alert (Australia) - June 10, 2014

In This Issue: Judgments, Legislation and Reports. Excerpt from Reports: Queensland. Department of Health - 3 June 2014 - Strong plan delivers improving health services. The Health budget for...more

New Clinical Trial Rules in the EU: A First Overview

Last week, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use was published in the Official Journal of the European Union. The Regulation establishes a single, EU-wide harmonised set of rules...more

Significant Revisions to China’s Regulations on the Supervision and Administration of Medical Devices (State Council Order No....

China’s State Council released its new Administrative Regulation on the Supervision and Administration of Medical Devices March 7, 2014, which will be effective June 1, 2014 (the “New Regulation”). The State Council...more

Health Alert (Australia): Week of May 30, 2014

In This Issue: Judgments; Legislation; and, Reports. Excerpt from JUDGMENTS: New South Wales (NSW) - 21 May 2014 - Neville v Lam (No 3) [2014] NSWSC 607 - The practitioner is a gynaecologist...more

FDA Targets Medical Device Companies

FDA Developing New Risk and Benefit Perception Scale - Since 2008, the U.S. Food and Drug Administration has increased its presence and tightened its control over medical device companies, and this trend is expected to...more

Health Alert (Australia) - May 19, 2014

In This Issue: Judgments, Legislation, and Reports. - Excerpt from Judgments: Commonwealth - 13 May 2014 - Sklavos v Australasian College of Dermatologists [2014] FCA 476 - This was a Federal...more

IARC Advisory Group Recommends Multi-Walled Carbon Nanotubes as High Priority

An International Agency for Research on Cancer (IARC) Advisory Group met on April 7-9, 2014, to recommend priorities for IARC Monographs during 2015-2019. The Advisory Group assessed the responses to a call for nominations...more

Health Alert (Australia) - May 12, 2014

In This Issue: Judgments; Legislation; and Reports. JUDGMENTS - New South Wales (NSW)- 6 May 2014 - Health Care Complaints Commission v Khalsa (No 2) [2014] NSWCATOD 47 - This was an application...more

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