January 15, 2018
On December 15, 2017 Philippine Food and Drug Administration (FDA) announced some changes in the Application of Variation of Certificate of Product Registration for Medical Devices.
Due to increased volume of variation applications, FDA recognizes the need to improve the procedure in this application.
FDA Circular 2017- 014 shall cover all medical device industry which has variation, amendment, or changes in the CPR issued by the Center for Device Regulation, Radiation Health and Research (CDRRHR). Further, the notice of approved changes shall be applied to all variation applications received from 22 July 2016 onwards.
The filing of application shall be guided by FDA Circular No. 2016-010. However, the new procedures in the application for variation of medical device product registration shall be as follows:
- The applicant can file for only one (1) variation application in single transaction, regardless of the number of issued Certificate Product Registration (CPR). The nature of changes that shall be considered are as follows:
§ Change of legal manufacturer, exporter and manufacturer provided that the name and address of legal manufacturer, exporter and manufacturer are the same for all CPR's to be amended.
§ Change of importer and distributor
§ Change of location and/or address of importer and distributor
§ Change of address of manufacturer
§ Change and/or addition of sterilization site
§ Change of label design
§ Change of instruction for us
All other changes which are the same or uniform with the issued CPR's
- Fees and charges shall be computed based on the number of CPR's to be amended. The list of all CPR's to be amended shall also be submitted using the format prescribed in Section III of FDA Circular 2017-014.
- The applicant shall be informed of the approved changes in the form of letter, and this shall be applied to all variation applications received from 22 July 2016 onwards.
- Further, all approved changes shall be reflected in the CPR during the renewal of the product registration.
- The company may request re-issuance of the CPR to reflect all the changes in the CPR upon payment of the reissuance fee.
This process will require Authorized Representatives, Importers, as well as manufacturers to keep letter of notice of the approved changes for future reference. Moreover, this would simplify the process, especially if the manufacturer needs to apply more than one medical devices with same type of variation.
This Circular shall take effect 15 days after approval.
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