Titans Medical

Ensuring patient safety doesn’t end with regulatory approval—it continues throughout the entire lifecycle of your device. For medical device manufacturers, two pillars of compliance and safety stand out: biocompatibility testing and post-market surveillance (PMS). This blog will guide you through the essentials of both, based on official global regulatory guidance from FDA, WHO, and MHRA, […]

Introduction In India, dental devices—from implants to orthodontic brackets—must meet strict regulatory standards before entering the market. A Device Master File (DMF) is one of the most critical documents in the Central Drugs Standard Control Organization (CDSCO) registration process. The DMF serves as a comprehensive dossier that demonstrates the safety, quality, and performance of a

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.