Regulatory Services

Medical device registration is a crucial step in ensuring the safety, quality, and efficacy of healthcare products before they reach the market. This process involves thorough evaluation and approval by regulatory authorities to confirm compliance with established standards and regulations. Manufacturers must submit comprehensive documentation, including product details, clinical evidence, and manufacturing processes. Successful registration indicates that a medical device meets the required standards for distribution and use. This regulatory measure not only safeguards public health but also promotes confidence among healthcare professionals and consumers in the reliability and effectiveness of the registered medical devices.

Many nations mandate that international manufacturers appoint a local authorized representative (LAR) within the country if they opt against establishing a foreign subsidiary. This representative, also referred to as the in-country representative, local agent, or marketing authorization holder, assumes the regulatory liaison role for the medical device or in vitro diagnostic (IVD). The LAR serves as the foreign manufacturer's representative in all interactions with local medical device authorities, handling tasks such as product registrations, import licenses, distribution licenses, change notifications, and post-market surveillance, including managing adverse events and product recalls.