International Medical Device Regulatory Monitor

Two draft proposals intended to help European devicemakers and notified bodies prepare for the transition from three medical device directives (MDD) to two major regulations are beginning to circulate prior to the European Commission’s (EC) expected release of the draft regulations on Sept. 26, an expert tells IMDRM. Includes the full text of EC Draft Regulation on the Designation and Supervision of Notified Bodies.

Known for its relatively relaxed regulations on companion diagnostics (CDx), guidance from the European Medicines Agency is not expected until there is more experience with these drug-device products, an expert says.

Devicemakers seeking ISO 13485 certification can expect longer initial audits of their quality management systems (QMS), thanks to a new mandatory document by the International Accreditation Forum (IAF).

The EU last month published its much-anticipated regulation on medical devices and active implantable devices that use tissues of animal origin, but any impact on devicemakers is expected to be minimal, experts say.

Medical devicemakers should report all adverse events in premarket clinical trials and any device deficiencies that might lead to a serious adverse event (SAE), according to the Global Harmonization Task Force’s (GHTF) final guidance on reportable events.

A newly released draft guideline on clinical trial death and injury compensation in India has clinical researchers concerned about how the basis for claims will be decided and payments formulated.

Brazil’s Anvisa should be operating again at full capacity by mid-September, following government strikes that crippled the agency this summer and left devicemakers unable to obtain registration licenses or get their products in and out of the country.

Manufacturers of Class III and Class IV in vitro diagnostic (IVD) devices will submit similar clinical and scientific information for summary technical document (STED)-based and non-STED-based license applications and amendments in Canada, according to two draft guidance documents.

Medical devicemakers in Canada will now have to pay a fee to renew their establishment licenses annually by April 1, or face cancellation and enforcement actions, according to an updated Health Canada guidance.

In an effort at greater transparency, the European Medicines Agency (EMA) has begun publishing public assessment reports (PAR) for ancillary drug substances incorporated in medical devices.

Device approvals may take longer in the U.S. than in the EU — but the fact that U.S. insurers are quicker to pay for new technologies means patients benefit from new devices at roughly the same speed in both places, a new study suggests.

A public-private partnership looking to speed introduction and coverage of new medical technologies in Canada is expanding, as three devices involved in the initial phase of the program are being readied for premarket evaluation to build evidence for approval and adoption.

The U.S. Food and Drug Administration (FDA) has compiled a checklist for agency staff and industry to use in determining whether a 510(k) submission is adequate and ready for review, as part of the agency’s move from a 30-day to a 15-day time-to-acceptance decision.

U.S. Food and Drug Administration (FDA) fiscal 2013 medical device user fee rates, laid out in a July 31 Federal Register notice, match amounts set during Medical Device User Fee Act negotiations between the agency and industry representatives.