International Medical Device Regulatory Monitor

SEATTLE — A planned overhaul of China’s medical device regulations could ease the cumbersome registration process foreign companies now confront, an expert says.

Medical device companies looking to introduce high-risk devices in Singapore will have the option of expedited registration evaluation routes, according to a draft guideline from the Health Sciences Authority (HSA).

Medical devicemakers can now register products in Mexico in about six months using foreign equivalency pathways or third-party reviewers, an expert says.

EU health and consumers commissioner John Dalli resigned Oct. 16 amidst an investigation by OLAF, the EU’s antifraud office, into allegations a Maltese entrepreneur attempted to leverage his contacts with Dalli for financial gain and influence on legislative proposals related to tobacco products.

On Sept. 26, the European Commission released proposed legislation revising the EU’s medical device and in vitro diagnostic device directives and setting the stage for the revisions to be implemented uniformly across member states as regulations. The proposed regulations include a number of provisions aimed at strengthening premarket and postmarket controls of medtech products authorized in EU markets. In the coming months, IMDRM will focus on some of the more significant reforms to prepare devicemakers for the changes to come.

European notified bodies (NB) must conduct unannounced inspections of medical devicemakers at least once every three years for Class I, IIa and IIb devices and once every two years for Class III and active implantable medical devices (AIMD), according to the new code of conduct released by the European Association of Notified Bodies Oct. 10.

Organizations that audit device establishments must ensure that their findings document conformity, nonconformity or potential nonconformity with established best practices based on objective evidence, according to a draft standard released by the International Medical Device Regulators Forum (IMDRF).

SEATTLE — A new two-way electronic communication standard may ease new product discussions between device companies and regulators and eventually establish common premarket requirements for device applications, an expert says.

SEATTLE — The U.S. Food and Drug Administration’s (FDA) Office of International Programs (OIP) is exploring development of a single, global recall system that would encompass all domestic and international recalls.

SEATTLE — The U.S. Food and Drug Administration is considering the creation of a new Division of International Compliance Operations within the Center for Devices and Radiological Health’s (CDRH) Office of Compliance (OC) as part of the center’s efficiency drive and the agency’s increased international focus, CDRH officials say.

Abdominal aorta aneurysm (AAA) screening and prognostic tests for breast cancer recurrence may offer benefits to specific populations, but a lack of data on both may be keeping the European network for Health Technology Assessment (EUnetHTA) from making a clear recommendation on their use.

France’s National Health Authority (HAS) will conduct a cost-utility analysis followed by a cost-effectiveness analysis to evaluate medical devices that are expected to impact health-related quality of life, according to a new guide on economic evaluation of health interventions.

The EU’s centralized medical devices database, Eudamed, contains incomplete information on devices and stakeholders, lacks transparency and is burdensome for competent authorities to use, a review by the European Commission concludes. Includes the full text of European Commission’s Review of EudaMed.

The Asian Harmonization Working Party (AHWP) has unveiled a framework for the next eight years to expand its membership, increase training and capacity building and build on harmonization efforts with other Asian countries.

The U.S. Food and Drug Administration (FDA) has released updated guidance describing how it intends to comply with submission review timelines set during user fee negotiations earlier this year.