Companies with valid license to operate (LTO) as medical device distributor-importer/wholesaler can file for application for product registration. Only complete documents will be accepted during the application.
The application will be reviewed and evaluated if in accordance with the requirements. All complying applications will be issued a certificate of product registration. All non-complying applications will be issued a notice of deficiency. Each company is given a non-extendable ninety (90) days compliance period. All those who will not be able to comply will be disapproved but will be given a period of sixty (60) days to file for re-application and comply with all the deficiencies. In case after this period the application did not satisfactory comply all the requirements, the application will be disapproved and the company needs to file for initial application.
The BHDT is the recommending office for approval of the CPR. All CPRs are forwarded to FDA (BFAD) for approval.