July 13, 2018

All concerned Industry/Stakeholders were invited to attend the FDA Executive Presentation on New Fee Structure and Modernization scheduled last June 28-29 which was held at the Philippine International Convention Center, Pasay City. Based on the informal talks between Qualtech and PFDA, the said seminar covered some topics concerning the Implementation of the Upcoming New Regulation entitled: Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements (AO 2018-0002). Participants of the said event also discussed regarding the change in fees for the registration application, licensing of establishments, renewal, post approval application, among others. The summary of the said Presentation shall be posted in the succeeding issues.