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ANVISA ANMATII

Washington, D.C., 30 December 2019 (PAHO)- National Regulatory Authorities (NRAs) of Argentina (ANMAT) and Brazil (ANVISA) made the first exchanges of medical devices audit reports using the Regulatory Information Secure Exchange (RISE) module. 

RISE is a module within the Regulatory Exchange Platform – secure (REPs) that allows participating NRAs to benefit from a protected space to exchange nonpublic regulatory information. Such exchange promotes reliance practices in the Region, improves processes efficiency, and expands regulatory convergence.

Launched in March 2018, the broader platform of REPs is the result of a series of initiatives to improve the efficiency of health technology regulation through international and inter-institutional collaboration. REPs meets the safety standards defined by the participating NRAs, and currently has two modules:

  • MDSAP, to support the Medical Device Single Audit Program activities, where NRAs from Brazil, Canada, United States, Australia and Japan participate; and
  • RISE, which participation is open to the authorities that adhere to REPs through a memorandum of understanding between the NRA and PAHO, and where participation allows sharing of different kinds of non-public regulatory information across product types.

The NRAs in the Americas with an interest in exchanging medical device audit reports find support in the project approved by the Regional Working Group for the Regulation of Medical Devices and whose objective is to “exchange audit reports on Good Manufacturing Practices (GMP) of medical devices in order to grant the GMP Certificate required for product registration.” Audit reports are GMP documents that indicate findings during inspections for licensing or renewal of activities, or at any time when process variations or specific investigations of suspected product quality problems are reported.

RISE is the result of the joint effort between PAHO and NRAs; it is expected that its use can be extended throughout the Region and at the Global level.