QuestionsQuestions (FDA CIRCULAR NO. 2017-014)
Section 5(e) mandates the FDA to issue certificates of compliance with technical requirements as a basis for appropriate authorization and for spot-checking compliance with regulations regarding the operation of establishments and facilities involved in health products.
The CPR is issued prior to importation and distribution of the medical device, serving as the product’s authorization/registration basis before market release.
It covers the medical device industry having variations/amendments/changes in the CPR issued by the Center for Device Regulation, Radiation Health, and Research (CDRRHR).
The applicant can file only one (1) variation application in a single transaction regardless of the number of CPRs to be amended.
The change is allowed provided that the name and address of the legal manufacturer, exporter, and manufacturer are the same for all CPRs to be amended.
Examples include: change of importer and distributor; change of location/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 Use (IFU); and other changes that are the same or uniform with the issued CPRs.
Fees and charges are computed based on the number of CPRs to be amended.
The applicant must submit the list of all CPRs to be amended in both PDF and Word format using the specified format.
It must include: Product Description (exactly as stated in the CPR) and Product Registration Number.
The applicant is informed of approved changes through a letter.
It applies to all variation applications received from 22 July 2016 onwards.
All approved changes shall be reflected in the CPR during the renewal of the product registration.
The company may request the re-issuance of the CPR to reflect all changes upon payment of the re-issuance fee.
It takes effect fifteen (15) days upon approval.
It rescinds/repeals and/or modifies previous issuances that are inconsistent with the circular’s provisions.
It ensures that if any provision is held invalid, the remainder of the circular’s provisions remain effective.
Yes, under the one-transaction rule, as long as only one variation application is filed and the nature of the changes are eligible (uniform/covered types) as contemplated by the circular; fees are still based on the number of CPRs amended.