Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”
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Importing medical devices into Thailand is more difficult than in other countries in the region. It is important to work with an importer with staff experienced with medical device imports to avoid customs clearance delays and added costs.
Considering the complexity of the importing test samples and the risk of test laboratories losing accreditation, it is important for manufacturers seeking medical or diagnostic device registration in Russia work with an experienced, local partner who can make an informed selection of test laboratories and take fast corrective action should the selected lab be affected.
US medical device manufacturers typically launch new products in Asia only after establishing success in the US and Europe. However, decisions made in the product development process have significant impact on regulatory costs, time to market and ultimately sales results in Asia. Address these four points to ensure fastest time-to-revenue in Asian markets.
The Thai FDA increased the regulatory status of alcohol-based sterilization devices from General to Class 2 Notified.
Asia Actual is excited to announce the dedication of our new office space in the Philippines. The investment reflects the company’s commitment to the Philippines market and expectations for growth.
Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate