What is the process for licensing of medical device establishment?

Companies who are selling registrable medical devices should apply for LTO. The requirements for the application of LTO can be downloaded from the DOH website. http://gwhs-stg01.i.gov.ph/~dohgov/licensing

Only complete documents will be accepted during the application and will be scheduled for inspection.

If the company complies with the requirements and passed the inspection, a license to operate will be issued. The company is given sixty days to comply with all the deficiencies. Non-compliance will result to temporary stoppage of the selling of medical devices.