EMERGO SUMMARY OF KEY POINTS:

• New ANVISA regulations incorporate risk factors into decisions about on-site inspections of Brazilian medical device companies seeking sanitary licenses.
• The new requirements apply only to distributors, Brazil Registration Holders (BRH) and manufacturers based in the country.
• The new regulations are currently in effect.

Brazilian medical device market regulator ANVISA has implemented new risk-based requirements for domestic companies to obtain sanitary licenses.

The new regulation, RDC 153/2017 (link in Portuguese), affects Brazilian manufacturers, distributors, Brazilian Registration Holders (BRH) and other firms involved in the country’s medical device sector. The regulation defines classifications of degrees of risk associated with different business activities of sanitary license holders; higher-risk activities will more likely warrant inspections by local Brazilian health authorities.

Although RDC 153/2017 does not directly impact foreign manufacturers selling in Brazil, companies should be aware of these new requirements impacting their Brazilian distribution, warehousing, BRH and related partners.

Risk-based site inspection requirements

Previously, all Brazilian companies seeking sanitary licenses had to first request on-site inspections from local health authorities, undergo those inspections and obtain inspection reports before applying for the federal license.

Through RDC 153/2017, decisions to conduct inspections of applicant sites are made using a risk-based approach; using a criterion called classification of economic activity (CNAE), local health regulators classify the risk level of a license applicant’s economic activity; high-risk applicants warrant inspections, while low-risk applicants do not.

ANVISA defines three CNAE risk levels:

• High risk: economic activities that require sanitary inspections or prior documentary analysis by health authorities; sanitary inspections or documentary analyses occur before licenses are issued for these applicants.
• Low risk: economic activities that may commence without sanitary inspections or documentary analysis; inspections occur after licenses are issues for these applicants.
• Information­-dependent: activities for which health authorities require information during the licensing process in order to determine whether to classify them as high- or low-risk.

A related Normative Instruction from ANVISA, IN 16/2017 (link in Portuguese), specifies CNAEs and their three-tier risk classification system.

Faster licensing for some Brazilian medical device companies

“With this regulation, local health authorities can optimize sanitary inspection activities based on risk factors,” explains Luiz Levy, Director of RA/QA at Emergo’s Brasilia office. “Authorities can prioritize their inspection efforts for high-risk establishments, which will reduce the queue for inspections that have historically been a problem in larger states for companies trying to launch or change operations.

“Additionally, this new regulation allows the sanitary license process to be performed electronically, which will assist the local authorities to deliver faster licensing decisions,” Levy adds.

Additional Brazilian market services and resources:

• ANVISA registration and approval support for medical device companies
• Brazil Registration Holder (BRH) in-country representation for foreign manufacturers
• Whitepaper: ANVISA medical device registration