Question & AnswerQ&A (FDA CIRCULAR NO. 2017-014)
The main law is Republic Act No. 3720, as amended by Republic Act No. 9711, also known as the Food and Drug Administration Act of 2009.
The FDA is mandated to issue certificates of compliance with technical requirements which serve as basis for authorization and spot-check compliance of manufacturers, importers, exporters, distributors, wholesalers, drug outlets, and other facilities of health products.
A Certificate of Product Registration is a certification issued by the FDA to health products prior to their importation and distribution to ensure compliance with relevant technical and regulatory standards.
A variation application is required whenever there are amendments, changes, or variations in the issued Certificate of Product Registration for a medical device.
Changes include change of legal manufacturer, exporter and manufacturer (if the name and address are the same for all CPRs), change of importer and distributor, change of location/address of importer/distributor, change of manufacturer address, change or addition of sterilization site, change of label design, change of Instruction for Use (IFU), and all other uniform changes with the issued CPRs.
Only one (1) variation application per single transaction is allowed regardless of the number of CPRs held by the applicant.
Fees and charges are computed based on the number of CPRs to be amended.
The applicant must submit a list of all CPRs to be amended using the prescribed format in both PDF and Word format, including product description exactly as stated in the CPR and the product registration number.
The applicant will be informed through a letter stating the approved changes.
The approved changes will be reflected in the CPR during the renewal of the product registration.
Yes, the company may request for the re-issuance of the CPR reflecting all changes upon payment of the re-issuance fee.
The separability clause provides that if any provision is held invalid, the rest of the provisions shall remain unaffected.
It took effect fifteen (15) days after approval on June 8, 2018.
The Licensing and Registration Division of the Center for Device Regulation, Radiation Health, and Research (CDRRHR) handles these applications.