Asia Pacific
Thailand
Welcome to our guide on the medical device registration process in Thailand. If you’re considering bringing a medical device to the Thai market, it’s essential to understand the key steps involved. Begin by classifying your device based on its risk level and designating a local authorized representative if you’re an overseas manufacturer. Implement a robust quality management system, such as ISO 13485 certification, to ensure product safety and effectiveness.
Prepare comprehensive documentation that includes technical files, labeling, and Vietnamese language instructions for use. Submit your application to the Ministry of Health’s Medical Device Administration, and undergo a rigorous evaluation process, which may include site inspections. Once approved, your device will receive a registration license. Compliance with post-market surveillance, including periodic reporting and updates, is vital to maintaining your presence in the Vietnamese market. Keep abreast of evolving regulations and seek professional assistance to ensure a smooth and successful registration process in Vietnam.
Vietnam
Exploring the Vietnamese market for medical device registration? Discover the essential steps for a successful entry. Start by classifying your medical device based on risk levels, considering Vietnam’s unique regulatory framework. Appoint a local representative or distributor, a requirement for foreign manufacturers looking to navigate the Vietnamese market. Prioritize product testing and conformity assessments with accredited laboratories in Vietnam.
Navigating this process can be complex, but you don’t have to do it alone. Our team of experts specializes in guiding businesses through every step of the registration process. We’ll help you classify your device correctly, gather the required documents, and ensure your device complies with Saudi Arabian regulations. By working with us, you can have confidence in bringing your medical device to the Saudi Arabian market, where it can contribute to improving healthcare services in the country. We’re here to make the journey smoother and help you meet all the necessary requirements for successful registration.
South Korea
Embarking on the journey of medical device registration in South Korea involves a strategic consulting process. It begins with a thorough assessment of your device’s compatibility with South Korean regulations, followed by the crucial step of regulatory classification based on risk. You’ll need to appoint a local representative, establish a robust quality management system, and meticulously prepare documentation in compliance with South Korean standards.
Submission of your application to the Ministry of Food and Drug Safety (MFDS) initiates a rigorous evaluation, which may include testing and inspections. Upon successful review, you’ll obtain a registration certificate, granting access to the dynamic South Korean market. Maintaining post-market compliance and staying updated on evolving regulations are integral to long-term success. Our consulting process offers a structured approach, ensuring a smooth and compliant journey through South Korea’s medical device registration landscape.
Australia
At Titans Medical, we are your gateway to navigating the world of medical device registration in Australia. We understand the complexities involved in complying with Australian regulations and strive to simplify this process for you. The Therapeutic Goods Administration (TGA) is responsible for overseeing medical device registrations in Australia, ensuring their safety and effectiveness for both patients and healthcare professionals.
Our experienced team is dedicated to providing you with unwavering support throughout the registration process, ensuring your full compliance with TGA requirements and standards. From initial assessments to meticulous documentation preparation, Titans Medical offers comprehensive services to empower you to confidently introduce your cutting-edge medical devices to the Australian market. Count on Titans Medical as your partner in achieving a seamless and successful medical device registration in Australia
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