Titans Medical

Bringing a medical device into the Indian market is more than just ticking boxes—it’s about navigating a dense regulatory landscape, starting with the Free Sale Certificate (FSC). Whether you’re a foreign manufacturer seeking CDSCO registration or an Indian importer managing timelines and documentation, understanding Indian FSC requirements is critical for a smooth registration process. This […]

In recent years, China has taken bold steps to make healthcare more affordable and equitable. One of the most impactful moves in this direction is the inclusion of medical devices under insurance reimbursement schemes, driven by mandates from the country’s central health authorities. By aligning device coverage with public health priorities, China is not only

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

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.

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

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