International Medical Device Regulatory Monitor

As widely anticipated in the wake of the PIP breast implant and metal-on-metal hip scandals, the European Commission is proposing that high-risk medical devices undergo more rigorous premarket scrutiny, but not on the level required by the U.S. Food and Drug Administration (FDA). Includes the full text of Q&A on Proposed EU Medical Device, IVD Regulations.

A newly proposed EU regulation on in vitro diagnostic medical devices seeks to align IVD classification with the Global Harmonization Task Force’s risk-based model — a move that could place new requirements on the majority of current Class A IVDs by bumping them up to Class B.

China’s proposed update to good clinical practice requirements for medical devices includes tougher provisions on ethics committees and human subject protections.

New South Korean requirements for medical devices introduced this year make the country’s already strict regulation of foreign devicemakers even more rigorous, an expert says.

India’s medtech industry is expected to grow by more than 15 percent annually as the country’s middle class and insurance coverage begin to ramp up, according to a PricewaterhouseCoopers (PWC) survey of Indian medical device companies.

While most Southeast Asian nations have laws spelling out the kinds of gifts and payments device and drugmakers can and cannot make to local healthcare providers, many struggle to enforce them when companies cross the line, experts say.

The Saudi Food and Drug Authority has rejected millions of dollars in medical device imports over the past three years, in an effort to prevent substandard products entering the country, an SFDA official says.

In response to the rapid rise in counterfeits, the International Organization for Standardization (ISO) has issued a new industrywide standard to help ensure the life-cycle integrity of products.

Health Canada plans to shift health product monitoring to a total product lifecycle approach in the coming years, the agency said in a Sept. 12 document detailing a new framework for health product vigilance.

Manufacturers of transdermal patches should minimize the amount of residual drug substance in the patch as much as possible to avoid patient and environmental safety risks, according to a new European Medicines Agency (EMA) draft guideline.

Despite launching in 2010, the U.S. Food and Drug Administration’s (FDA) Medical Device Epidemiology Network (MDEpiNet) is still trying to determine which existing patient registries and surveillance systems to emulate to enhance device postmarket surveillance, stakeholders said at a Sept. 11 FDA public workshop.

The U.S. Food and Drug Administration (FDA) plans to issue clarifying guidance to address confusion among devicemakers about what exactly constitutes an enhancement and what qualifies as a recall, an FDA official says.