Introduction. India’s regulatory landscape for medical devices has seen a significant shift. Effective 1st April 2020, the Government of India brought all medical devices under the scope of “drugs” as defined in the Drugs and Cosmetics Act, 1940, making them subject to quality regulation and price control under the Drugs (Prices Control) Order, 2013 (DPCO […]
Price Control and Market Access in India for Medical Devices Read More »
Introduction Thailand’s medtech sector is fast emerging as a hub for innovation and regional market access. With the country aligning its medical device regulatory system to the ASEAN Medical Device Directive (AMDD), manufacturers targeting Thailand must now adhere to stricter, harmonized requirements, starting with accurate device classification. However, classification is not merely an administrative checkbox.
Thailand’s Medical Device Classification Explained: Class 1 to Class 4 under AMDD Read More »
Introduction If you’re planning to introduce your medical device to the Thai market, you’re tapping into one of Southeast Asia’s most promising healthcare economies. With Thailand’s growing demand for advanced medical technologies, especially in diagnostics, surgical equipment, and digital health, the opportunities are significant. However, successfully accessing this market begins with a critical step: Thai
Navigating Thai FDA Registration: A Step-by-Step Guide for Medical Device Manufacturers Read More »
Introduction: Gaining ANVISA certification is a significant milestone for any medical device manufacturer aiming to access the Brazilian market. However, the journey doesn’t end with product registration. Maintaining ANVISA certification requires continuous compliance with post-market requirements set forth by Brazilian regulatory authorities. These obligations not only help safeguard patient safety but also ensure that your
How to Maintain ANVISA Certification: Post-Market Requirements in Brazil Read More »
Introduction Brazil is one of Latin America’s largest and most complex medical device markets, governed by the National Health Surveillance Agency (ANVISA). Manufacturers aiming to enter this market must navigate a stringent regulatory framework to obtain and maintain market authorization. Despite clear guidance from ANVISA, companies frequently make avoidable mistakes that delay product approval or
Top 5 Medical Device Compliance Mistakes to Avoid in Brazil Read More »
Introduction As Brazil continues to solidify its position as a significant player in the global medical device market, understanding its regulatory landscape becomes paramount for manufacturers aiming to enter or expand within this dynamic environment. A fundamental aspect of this landscape is the classification of medical devices, governed by the Brazilian Health Regulatory Agency (ANVISA).
Understanding Medical Device Classification in Brazil Read More »
