International Medical Device Regulatory Monitor

Devicemakers view several developing countries as having the most difficult regulatory systems but the greatest opportunity for growth, according to industry survey results.

After 19 years of working hand-in-hand on the Global Harmonization Task Force (GHTF), regulators have informed industry they plan to dissolve the committee and create a new policy making group without industry input.

Rolling blackouts and transportation disruptions are among the problems facing devicemakers in Japan as they deal with the aftermath of a massive 9.0 earthquake and the ensuing tsunami.

Sweden’s recent objections to an international standard for medical device regulatory requirements could lead to a more coherent approach for the EU.

Industry supports risk-based classification of in vitro diagnostics (IVDs) as part of the Medical Devices Directives (MDD) recast, responses from a European Commission (EC) public consultation show.

Some manufacturers, and in vitro diagnostics (IVDs) in certain classes, will need a Conformity Assessment Certificate to supply devices to Australia’s market, regardless of whether they have certificates or licenses from overseas bodies, according to the Therapeutic Goods Administration’s (TGA) Conformity Assessment overview.

As the U.S. Food and Drug Administration (FDA) prepares to release its proposed rule for a unique device identifier (UDI) database, devicemakers are off the hook for UDI label scrutiny during premarket review.

When an advanced therapy medicinal product (ATMP) incorporates a medical device, the resulting “combined ATMP” must undergo regulatory review by the European Medicines Agency (EMA), according to the agency’s procedural advice on evaluating these products and the consultation of notified bodies (NB).

Despite the Court of Justice of the EU’s (CJEU) negative opinion on the proposed European and Community Patent Court, devicemakers can still look forward to continued work toward the initiation of an EU-wide unitary patent system.

Recent regulatory shakeups in Brazil, focusing on patents and standards, mean major changes for the country’s medical device approval processes.

Device manufacturers have won a victory in U.S. Congress now that the Senate has passed patent-reform legislation that includes several provisions favorable to the industry.

Devicemakers and consumers can more easily find warnings and approval information for Australian medical devices now that the country’s Therapeutic Goods Administration (TGA) has improved the search functions of the Australian Register of Therapeutic Goods (ARTG).

Devicemakers of 13 types of products may need to adjust to new standards in U.S. Food and Drug Administration (FDA) premarket reviews.

Citing a dramatic spike in thefts of medical devices and prescription drugs, a group of U.S. Democratic senators March 8 introduced federal legislation to crack down on medical product heists at every point in the supply chain.