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.”
Tag Archive for: medical device sales
The novel characteristics of AI software and Software as Medical Devices (SaMDs) are stressing bureaucratic regulatory, customs and taxation systems around the world. Thailand is no exception.
The NMPA has been highly active in 2020 updating many of their regulations, standards and processes. If you’re considering entering the Chinese market, please contact us to identify how some of the new changes could affect your time and costs. Asia Actual Can Help Navigate the Evolving Regulatory Process in China
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.
As part of the NMPA’s ongoing regulatory evolution, the Chinese competent authority, formerly known as the CFDA, has released a draft list of new product types to be considered exempt from clinical trials as part of the registration process moving forward.
Medical device manufacturers are advised to prepare e-Catalogue applications early and be vigilant for the enrollment announcement. Implementing an optimal pricing strategy will be critical to successful public hospital sales. The e-Catalogue system also increases the importance of independent license holding in Indonesia because there is little room for regional dealer margin under the price scheme.
Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.
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.
Uncertainty. If there is one word that best describes the global outlook during the 2020 pandemic this might be one that everyone can agree on.
Vietnam has been quietly transforming their economy of 100 million people into a regional powerhouse. Through a combination of significant private investment, the US-China trade war, and their highly successful handling of the Coronavirus, Vietnam’s economy is expected to rebound quickly, especially with regards to manufacturing.