New Procedure for Variations in Medical Device CPR

Republic Act No. 3720 (Food, Drugs and Devices and Cosmetics Act) provides the foundational regulatory system for authorizing, registering, and monitoring health products.
Republic Act No. 9711 (Food and Drug Administration Act of 2009) amended Republic Act No. 3720 and empowered the FDA to regulate health products.
Section 5(e) of Republic Act No. 9711 mandates the FDA to issue certificates of compliance with technical requirements as the basis for authorization and spot-checks for compliance with regulations affecting manufacturers, importers, exporters, distributors, wholesalers, drug outlets, and other health product establishments and facilities.
The FDA issues CPRs for health products prior to importation and distribution.
When amendments, changes, or variations occur to an issued CPR, companies must file a variation application.
The circular is guided in filing by FDA Circular No. 2016-010, subject to the new procedures in Section III.

The FDA recognizes the need to improve effectiveness and efficiency due to the increased volume of variation applications.
The circular sets a streamlined procedure for variation applications involving medical device CPRs.

The circular covers all medical device industry that has a variation, amendment, or changes in the CPRs issued by CDRRHR.
The covered CPR changes are those affecting medical devices processed under the Center for Device Regulation, Radiation Health, and Research (CDRRHR).

An applicant may file only one (1) variation application in a single transaction, regardless of the number of issued CPRs to be amended (Section III.1).
The circular allows a single variation application to cover any CPR amendments falling under these permitted change types:
- A change of legal manufacturer, exporter and manufacturer when the name and address of the legal manufacturer, exporter, and manufacturer are the same for all CPRs to be amended (Section III.1(a)).
- A change of importer and distributor (Section III.1(b)).
- A change of location and/or address of importer and distributor (Section III.1(c)).
- A change of address of manufacturer (Section III.1(d)).
- A change and/or addition of sterilization site (Section III.1(e)).
- A change of label design (Section III.1(f)).
- A change of Instruction for Use (IFU) (Section III.1(g)).
- All other changes that are the same or uniform with the issued CPRs (Section III.1(h)).

Fees and charges are computed based on the number of CPRs to be amended (Section III.2).
The applicant must submit a list of all CPRs to be amended using a specified format (Section III.3).
The CPR list must be submitted in both PDF and Word format (Section III.3).
The list must include the following items (Section III.3):
- Product Description (exactly the same as stated in the CPR)
- Product Registration Number

The applicant must be informed of the approved changes through a letter (Section III.4).
All approved changes must be reflected in the CPR during the renewal of the product registration (Section III.5).
The procedures apply to all variation applications received from 22 July 2016 onwards (Section III.4).

A company may request re-issuance of the CPR to reflect all the changes in the CPR.
Re-issuance is conditioned on payment of the re-issuance fee (Section III.6).

Prior issuances that are inconsistent with the circular are rescinded/repealed and/or modified accordingly (Section IV).
If any provision or its application is held invalid, the remainder of the circular remains unaffected (Section V).
The circular takes effect fifteen (15) days upon approval (Section VI).