Impact for Medical Device and Drug Manufacturers

The National Health Surveillance Agency (ANVISA) approved, at a meeting of the Committee for Strategic Management, Risks and Institutional Innovation (CGE), the list of priority Foreign Regulatory Authorities. This decision aims to consolidate regulatory trust (“reliance”), accelerating registration and inspection processes of medicines and medical devices in Brazil.

What Does This Mean for the Medical Device Industry?

Regulatory confidence allows ANVISA to use decisions by foreign authorities to support its own assessments, reducing analysis time and facilitating the entry of innovative products into the market. QR Group, specialized in health product regulation, is prepared to help manufacturers benefit from this initiative, ensuring a faster and more efficient process with ANVISA.

List of Selected Regulatory Authorities

Selected authorities play a key role in the registration and inspection of medical devices and medicines. Check out some of the main recognized institutions:

• Therapeutic Goods Administration (TGA) – Australia (Medical Device Registry)
• Egyptian Drug Authority (EDA) – Egito (Medical Device Registry)
• Thailand’s Food and Drug Administration (TFDA) – Thailand (Medical Device Registry)
• Medicines and Healthcare Products Regulatory Agency (MHRA) – United Kingdom (Medical Device Registration)
• Federal Commission for the Protection against Sanitary Risks (COFEPRIS) – Mexico (Medical Device Inspeção)

Benefits of Regulatory Trust

The adoption of this model provides several advantages:

• Accelerates market access: Reduction in the approval time of products already recognized by international authorities.
• Reduces bureaucracy: Uses information from records and inspections already carried out.
• Increases regulatory predictability: Manufacturers have greater security in certification processes.
• Strengthens ANVISA’s position: Contributes to the agency’s recognition as a global reference.

How Does QR Group Help Manufacturers with Regulation?

With expertise in medical device regulation, QR Group offers complete support for companies that want to take advantage of the benefits of regulatory trust. Our services include:

• Regulatory feasibility analysis: Identifies opportunities to reduce timelines and costs.
• Process management at ANVISA: Agility in petitioning and registration.
• Specialized technical consulting: Advice on good manufacturing practices and regulatory compliance.

Contact Us

If your company manufactures medical devices and wants to optimize its regulatory process with ANVISA, count on QR Group. Our specialized team ensures security, agility and compliance for your business.

Contact us today and speed up your registration in Brazil!

Source: ANVISA