Recently, there is a new regulation that allows the Thai FDA to hasten the review of device registration dossiers. It has agreed to let device companies reference registration dossiers for new registrations of the same product with different brand names. In short, the Thai FDA is trying to reduce duplication efforts and expedite product approvals. In addition, the new regulation also enables device licenses (Classes 2,3, and 4) to be transferred from one entity to another entity if there is a change in the importer or manufacturer, as long as the manufacturing location of the device is the same. Transfers of registration dossiers or device licenses will require that all documents be submitted in CSDT format. Other requirements may be put in place in the near future too.
Device registration in Hong Kong is still done on a voluntary basis. Voluntary registration is valid for 5 years and is important since Hong Kong hospitals strongly prefer to buy devices that have been registered on the voluntary list. Recently, the Hong Kong Department of Health has issued a new timeframe for device renewals. Before, renewal applications needed to be submitted 12 weeks before the expiration of the device registration on the voluntary list. Now, renewal applications should be submitted up to 1 year in advance of expiration or at a minimum of 12 weeks before expiration. Renewal applications that do not meet these deadlines will not be processed. If the registration is not renewed on time, new registrations of the device will be needed.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.