(Reuters) — India plans to set up a regulator to oversee the country’s $4 billion medical device industry, according to a draft policy released this month, the country’s first effort to regulate an industry that covers everything from thermometers to prostheses. The policy document, welcomed by many in the industry despite concerns over a lack […]
Regulatory Affairs
Training for Costa Rican digital medical device registration pathway announced
By Stewart Eisenhart, Emergo Group
Costa Rican medical device regulators are preparing a system to facilitate online registration of medical devices in a move to drive up foreign manufacturers’ interest in the Central American market.
Device tax: Indiana Governor petitions Obama for repeal | MassDevice.com On Call
MASSDEVICE ON CALL — Indiana Governor Mike Pence (R) issued a formal letter to the White House yesterday, asking President Barack Obama to repeal the 2.3% medical device tax created in the Affordable Care Act.
Pence asked for President Obama’s support in "working with the Congress to repeal the medical device tax entirely," saying that the levy threatens 20,000 direct jobs and 55,000 total that rely on the medtech industry in Indiana alone.
FDA defends spying on medtech reviewers as lawmakers cry foul
Hiring and career development for RA/QA professionals
By John Baker
Through our experience, we have found the biggest challenge in recruiting and placing senior level Regulatory Affairs and Quality Assurance Executives, is finding the right balance of technical knowledge, communication skills and leadership qualities.
Colombian regulators simplify translation, grouping rules for medical device registration
By Stewart Eisenhart, Emergo Group
Colombian medical device regulator INVIMA has eased some translation and grouping criteria for market registrants.
IRS hit with another probe over medical records | MassDevice.com On Call
MASSDEVICE ON CALL — The IRS is under fire again, this time for allegations that it improperly seized millions of medical records in California.
The U.S. House Energy & Commerce Committee opened a probe of the alleged malfeasance by the federal tax bureau after a lawsuit filed in March charged the IRS with seizing 10 million records without a warrant or subpoena.
When conduct becomes a crime
By: John Roth
In my last post, I explained how FDA’s Office of Criminal Investigation (OCI) works when a small portion of the industry fails to adequately respond to regulatory action. For Abbott Laboratories and Amgen, the price for regulatory malfeasance was high: $1.4 billion – yes, billion – paid in criminal and civil penalties to the United States.
COFEPRIS strengthens ties to Mexican industry group, plans restructuring
By Stewart Eisenhart, Emergo Group
Mexican medical device market regulator COFEPRIS recently met with CANACINTRA, a major industry trade association, to discuss issues related to the country’s medical device sector. Emergo Mexico staff were in attendance.
Among medical device-related issues that came up at the meeting:
When regulators are ignored
By: John Roth
FDA’s collaboration with Chinese partners gets stronger each year
By: Mary Lou Valdez
“What’s in a name?” Shakespeare famously asked. “A rose,” his Juliet reasoned, “by any other name would smell as sweet.” And often, we know, that’s true. But other times, a change in name can signify some larger, more substantive shift.
The latter was the case in mid-April when we sat down in Washington to meet with one of China’s key regulatory agencies, the China Food and Drug Administration (CFDA).