Regulatory Framework

At Safetek Regulatory Services, we offer expertise in the regulatory frameworks of Brazil, Japan, USA, Australia, and Canada. Partner with us for effective navigation and support in certification, MDSAP consultancy, and safety testing.

Brazil Regulatory Framework

Navigating the regulatory landscape in Brazil requires a thorough understanding of the country's specific requirements. Our team specializes in certification support for ANVISA, the Brazilian Health Regulatory Agency. We guide manufacturers through the registration and approval processes, ensuring compliance with Brazilian regulations, including RDC 16 and RDC 185.

Japan Regulatory Framework

Japan's regulatory framework for medical devices is governed by the Pharmaceutical and Medical Device Act (PMD Act) and the Ministry of Health, Labour and Welfare (MHLW). Our expertise in Japan's regulatory requirements enables us to assist manufacturers in obtaining PMD Act certifications, navigating the Shonin approval process, and complying with the unique requirements of the Japanese market.x

USA Regulatory Framework

The United States has a robust regulatory framework governed by the Food and Drug Administration (FDA). Our team provides comprehensive support in complying with FDA regulations, including premarket notifications (510(k)), premarket approvals (PMA), and quality system regulations (QSR). We assist manufacturers in achieving FDA clearance or approval, ensuring compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Australia Regulatory Framework

Australia's regulatory framework for medical devices is overseen by the Therapeutic Goods Administration (TGA). Our expertise covers the Australian regulatory requirements, including conformity assessments, ARTG registrations, and compliance with the Australian Regulatory Guidelines for Medical Devices (ARGMD). We guide manufacturers in obtaining the necessary certifications and approvals to access the Australian market.

Canada Regulatory Framework

Health Canada regulates medical devices in Canada, and compliance with the Canadian Medical Devices Regulations is essential for market access. Our team offers guidance and support in obtaining Health Canada licenses, preparing and submitting medical device license applications (MDL), and ensuring compliance with the Canadian regulatory requirements.

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