In addition to saving resources, the MDSAP program represents an increase in health safety for health products, as auditors inspect companies more often.
The Medical Device Single Audit Program (MDSAP) reached, in 2019, the milestone of 5,000 participating companies. In addition, 48.7% of the total international health product certifications issued by Anvisa this year were made using the program.
The MDSAP is a rationalization program for inspection capabilities in the health care field, where, instead of multiple health authorities inspecting the same plant, a single inspection is performed by a third party audit body. This body represents all these authorities participating in the program.
The program started in 2015, with the participation of a small number of companies, until it was consolidated as a world reference program in 2019.
With the increase in companies participating in the program, Anvisa can conduct fewer international inspections and focus resources only on the most risky situations, ensuring efficient use of public money. In addition to saving resources, MDSAP represents an increase in health safety for health products, as auditors inspect companies more often, reporting annually to the Agency and other authorities participating in the program.
Foundation
Anvisa is a founding member of MDSAP, having designed and built the program from the outset, along with the following institutions: Therapeutic Goods Administration (TGA), Australia; Health Canada from Canada; U.S. Food and Drug Administration (FDA), United States; Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) from Japan.
Statistics
Check out more numbers from the unique health product audit program below.
Certificates issued
38 certificates issued by MDSAP in 2017 (4.7% of the total).
107 certificates issued by MDSAP in 2018 (19.3% of the total).
321 certificates issued by MDSAP in 2019 (48.7% of the total).
International Health Product Inspections
238 international health product inspections (2017).
110 international health product inspections (2018).
84 international health product inspections (2019).
Source : http://portal.anvisa.gov.br/noticias/-/asset_publisher/FXrpx9qY7FbU/content/programa-de-auditoria-unica-atinge-5-mil-empresas/219201?p_p_auth=tQoNDDBZ&inheritRedirect=false&redirect=http%3A%2F%2Fportal.anvisa.gov.br%2Fnoticias%3Fp_p_auth%3DtQoNDDBZ%26p_p_id%3D101_INSTANCE_FXrpx9qY7FbU%26p_p_lifecycle%3D0%26p_p_state%3Dnormal%26p_p_mode%3Dview%26p_p_col_id%3D_118_INSTANCE_KzfwbqagUNdE__column-1%26p_p_col_count%3D1