Qualtech introduced medical device regulations and the role of authorized representative in ASEAN in the seminar held by Tokyo University's association, which supports medical device innovation.
More The OMETA/Qualtech Webinar 2022 was held on September 29, featuring updates on regulations in Asia.
More As Qualtech offers Authorized Representative (License Holder) Services in 11 countries in Asia and Oceania, the following article outlines some of the benefits for foreign manufacturers associated with assigning a neutral 3rd party as their license holder. In addition, the product registration license conditions for the different ASEAN countries, as well as Taiwan, Japan, Hong Kong, Australia, and China are summarized, including license validity, license transfer possibilities etc.
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On September 17th, Qualtech hosted its Webinar on the subject of Japan Medical Device Registration to an international audience of MD manufacturers. During the event, the Qualtech team thoroughly explained the Japan registration process and elaborated on aspects such as registration timelines, product classifications, and consultation sessions with PMDA.
More On June 30th, Qualtech and ISS AG jointly hosted an online event informing far more than 100 different medical device manufacturers from all around the globe about China’s New Regulations. Qualtech’s team thereby detailed the important updates that the new RSAMD will bring, including the new obligations for product registrants under the nationwide adopted MAH system.
More On July 2nd, Qualtech had been invited to present and inform Japanese OMETA Members (Overseas Medical Equipment Technical Assistants) on the medical device regulation updates in Thailand, the Philippines, and Vietnam during the OMETA Online Seminar.
More On April 16th, Qualtech organized a webinar and guided participants through the Latest updates for medical device regulations in the Philippines, Thailand, and Malaysia. Our experts covered all the major topics and suggested details to pay attention to.
More Due to Qualtech’s vast experience in the ASEAN regulatory field, Qualtech’s specialists have been cordially invited to speak on the medical device registration processes in Vietnam, Indonesia, and the Philippines at the ASEAN Healthcare Market Conference.
More On February 25th, Qualtech organized a webinar and guided participants through the China medical device regulations. Our expert covered such topics as registration preparation, registration reviewing process, post-market process.
More The German-based “Society for Promotion of East West Knowledge Transfer” had invited the experts of Qualtech to share their knowledge on the Taiwan registration processes for medical devices and pharmaceutical products to a number of high-ranking and selected attendees. Within a 90-minute session held on November 10th, Qualtech guided participants through the different Taiwan certification procedures and further elaborated on the clinical requirements in place for pharmaceuticals.
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