Effective February 1, 2013, medical device and pharmaceutical manufacturers must now submit an electronic copy of the necessary forms in addition to a hard copy when applying for a License to Operate (LTO) and Certificate for Product Registration (CPR).
The requirements for the electronic copy are as follows:
- Scanned copy in PDF searchable format at least 300dpi
- On a DVD-R of the application
- Submitted with a notarized affidavit stating the attached electronic company application/product dossier is the exact duplicate of the hard copy
- The copy should be properly labeled (LTO/CPR Application)