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India’s medtech industry could reach $50 billion by 2025 if comprehensive regulatory and reimbursement infrastructures are put in place, a new market research report says. Read More
Devicemakers are urging the Therapeutic Goods Administration to amend its low-value turnover exemption scheme for entries in the Australian Register of Therapeutic Goods to allow more small businesses to take advantage of it. Read More
Makers of low and moderate risk devices can now use the U.S. Food and Drug Administration’s de novo pathway to gain approval without first filing for 510(k) clearance — a route the agency hopes devicemakers will take. Read More
The Therapeutic Goods Administration plans to obtain its own evidence on the quality of certificates and reports issued by select EU notified bodies, after a medical journal report cast doubt on the thoroughness of the reviews they were performing. Read More
The Brazilian government is proposing major reforms to its public-private Product Development Partnership program, doubling the allowable length of PDP agreements from five to 10 years and establishing a committee to approve the projects. Read More
Devicemakers could see their wait time to begin clinical trials cut by more than a third under a proposed regulation calling for protocols to be reviewed in their entirety, rather than in stages, as is the current practice. Read More
Sponsors of Class II and Class III medical devices in China may bypass the need for clinical trials if they can show that the product is equivalent to a product listed in the country, new guidance says. Read More
European trade groups and industry experts were cautiously optimistic regarding news that medtech oversight will move from the health directorate to industry, with some saying it will boost innovation and access to new therapies and others worried it could derail progress on regulatory reforms in the EU. Read More
The International Medical Device Regulators Forum’s single-audit pilot program is running on schedule, an FDA official working closely with the program tells IMDRM. Read More
The European Commission will soon launch an internal test of the International Medical Device Regulators Forum’s table of contents for medical devices and IVDs — documents designed to ease marketing authorizations process when companies file in multiple countries. Read More