SAN JOSE, Calif. – Regulators in Australia, Brazil, Canada and the United States signed an agreement to develop a unified medical device audit program, according to a report on Qmed, a sister publication of EE Times. Information from the unified audit program would be used by all four government regulatory groups, it said.
The so-called Medical Device Single Audit Program (MDSAP) aims to ease the process of getting approvals in participating countries. Once a device that meets the regulatory requirements in one of the member countries will be qualified for approval in all the member countries, said the article, citing as its source the Emergo Group (Austin), a global regulatory consulting firm.
Agencies involved in the work include the United States Food and Drug Administration, the Brazilian ANVISA, Health Canada and the Australian Therapeutic Goods Administration, Qmed said. The agreement aims to open the door to sharing work among the agencies, it said.
The move parallels efforts at the U.S. Patent and Trademark Office on its so-called Patent Prosecution Highway. That program speeds the process of granting a patent once a patent has been granted in a participating country.
Long and costly regulatory approvals remain a top challenge for medical electronics companies. In recent years, medtech companies have increasingly shifted to rolling out new products first in Asia and Europe given shorter regulatory pathways there.
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