The Medical Device Control Division held a meeting on 21 June to inform business operators that the new notification regarding the change of classification of contact lens care products from drugs to medical devices will soon be issued. Tentatively, after the notification comes into effect, the following actions will be required.
- Business operators holding drug registration licenses who would like to continue selling their contact lens care products must contact the Medical Device Control Division within a specified time to submit a request and obtain a temporary medical device registration license for each product that will be valid for two years. In parallel, the business operators must register their contact lens care products by submitting a Common Submission Dossier Template (“CSDT”) to obtain a medical device registration license that will be valid for five years.
- New contact lens care products must be registered as medical devices by submitting a CSDT for review and approval. The medical device registration license will be valid for five years.
The draft notification has not yet been released. This is the first public hearing and the information communicated to business operators above may be subject to change.