Faced with long waits for Brazilian good manufacturing practice certificates, some devicemakers are turning to the courts to speed up product registrations — and seeing their time to market cut in half, an expert says. Read More

Manufacturers should use a two-step approach to grade nonconforming products — a matrix for determining the initial number, followed by escalations to set a final grade, according to a proposed guidance released last month by the Asian Harmonization Working Party. Read More

CDRH’s Office of Compliance is sharpening its focus on international inspections and audits and on labeling, adding two new divisions to meet increasing enforcement demands. Read More

Kiwi devicemakers are crying foul over proposed fee structures for the Australia New Zealand Therapeutic Products Agency, saying they will stifle innovation among smaller medtech companies and limit access to new technologies. Read More

The U.S. Food and Drug Administration has created a new Division of International Compliance Operations to oversee inspections of foreign devicemakers and the international audit program. Read More

The International Medical Device Regulators Forum adopted four final guidance documents and two new work items relating to the Medical Device Single Audit Program during a meeting in Brussels last month. Read More

Devicemakers that operate in Brazil should be checking to see that none of their business holdings has been charged with corrupt practices — either in Brazil or elsewhere in the world, experts warned during a recent American Bar Association meeting devoted to the country’s new antibribery law. Read More

In the latest effort to clean up India’s troubled clinical trial industry, the government is requiring that clinical investigators video record the informed consent process with each study subject. Read More

Advisors to Ministry of Health and Family Welfare are calling for reforms to address weaknesses in India’s clinical investigation and medical products approval processes. Read More

In vitro diagnostics products meant for research or investigational use used commercially without appropriate approvals may be considered adulterated and misbranded, an FDA final guidance says. Read More