International Medical Device Regulatory Monitor
May 2011 | Vol. 19 No. 5 | Full Issue in PDF Format
Rising regulatory and operational costs are pushing some devicemakers to look for cheaper locations to set up shop — both domestically and overseas — as these comparative costs are ruling the corporate site selection process more than ever before, a recent study says.
On the verge of its reformation, the Global Harmonization Task Force (GHTF) has issued a guide for devicemakers on how to use each of its guidances during the medical device life cycle.
European device manufacturers may soon have new standards to adopt as the European Committee for Standardization (CEN) works to improve the accuracy of several standards that recently came under scrutiny.
In the next step toward an EU-wide single patent system, the European Commission (EC) has presented two proposals to reduce patent costs.
The European Commission (EC) is seeking comments on whether to include medical devices in revised transparency rules for member state decisions on pricing and reimbursement.
The European Commission (EC) has classified several “borderline” medical devices, including eye drops, in its most recent revision to the Manual on Borderline and Classification in the Community.
Device company executives can take several steps to avoid the pitfalls of centralized medical technology procurement in Europe, according to a European research institute.
Eucomed is asking the European Commission (EC) to help small and midsize devicemakers overcome four significant barriers to reaching their full innovation potential.
The UK has published guidance for industry on the Bribery Act 2010, which will go into effect this July, making bribery in the commercial sector a criminal offense. Includes the full text of Procedures to Prevent Bribery For The UK’s Bribery Act.
Brazil’s National Agency for Sanitary Surveillance (ANVISA) will begin charging inspection fees for certificates of good manufacturing practice (GMP) and quality control every two years instead of annually.
Argentina’s National Medicines, Food and Medical Technology Administration (ANMAT) is launching a traceability program for healthcare products to help combat counterfeits.
A panel conducting a transparency review of Australia’s Therapeutic Goods Administration (TGA) has been granted a two-month extension after a request from the panel’s chair.
The Ontario government is working with medical device association MEDEC to better assess the value of medical devices before they are brought to market in an effort to improve early-stage adoption of new devices.
The reformation of the Global Harmonization Taskforce (GHTF) without industry participants may threaten industry and regulator input on an international design and manufacturing standard.
A final U.S. Food and Drug Administration (FDA) guidance on request for designation (RFD) of hard-to-classify combination products informs sponsors of what information should be included.
The U.S. Food and Drug Administration (FDA) has released a guidance and final rule classifying low-level laser systems for aesthetic use into Class II with special controls.
The U.S. Food and Drug Administration (FDA) is down-classifying ovarian adnexal mass assessment score test systems from Class III into Class II with special controls.
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