The Global Medical Technology Alliance (GMTA) issued a new position paper to offer seven key elements in support of international regulatory convergence.
The four-page position paper comes as the push for international harmonization of medical device regulations continues to gain momentum, with more and more countries joining initiatives such as the International Medical Device Regulators Forum (IMDRF).
The GMTA urges for a harmonized least burdensome regulatory system for all medical technology companies, regardless of their country of origin, as well as transparency, predictability and efficiency around government-imposed regulatory controls.
“Movement toward international regulatory convergence should be further advanced by seeking a common regulatory approach” because countries’ “differing regulations create unnecessary market entry hurdles, and often present as non-tariff technical barriers that impede international trade, hinder market acces, delay patient access and increase costs,” GMTA said
. Its members include AdvaMed, Canada's Medical Technology Companies, MedTech Europe and the Medical Imaging & Technology Alliance, among more than a dozen other trade associations worldwide.
The seven elements outlined in the position paper aim to advance the mission of the Global Harmonization Task Force (GHTF), which was replaced by IMDRF, starting with the use of GHTF guidance documents as a foundation.
Other recommendations range from a commitment to set specific timelines to review premarket applications and allow the use of foreign clinical data to avoid requirements on re-registration or re-assessments and on initial product approval in a home country or country of manufacture.
The paper also supports the use of third-party reviewers among regulatory authorities “at least to evaluate low to medium risk medical technology.” The sixth element cites the Medical Device Single Audit Program (MDSAP)—a cornerstone of IMDRF—as a pilot study that was launched about five years ago to promote the idea of “one audit, one certificate, many countries.”
The US Food and Drug Administration issued
draft guidance last month that sets the stage for how the agency intends to leverage MDSAP for greater use of third-party reviewers. The agency also plans to use
the MDSAP framework to support blending 21 CFR Part 820 and ISO 13485.