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Checklist Requirements IVD

FDA medical device registration checklist for the registration requirements of an in vitro diagnostic device

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: QWP-CDRRHR/LRD-03 Annex 01
Rev. No. 05 Date Effective: 18 October 2017

CHECKLIST OF REQUIREMENTS FOR THE REGISTRATION OF AN
IN VITRO DIAGNOSTIC DEVICE
REQUIREMENTS
1. Table of Contents (with page number)
2. Notarized Application Form from Distributor
(Importer/Exporter/Wholesaler)/Local Manufacturer/Trader
3. Certificate of Brand Name Clearance (for branded products, if applicable)
4. Valid License to Operate (LTO) of an IVD Distributor (Importer/ Exporter/
Wholesaler)/ Local Manufacturer/Trader
5. Valid Government Certificate of Clearance and Free Sale/Registration
approval of the Product from the country of origin issued by the Health
Authority and duly authenticated by the territorial Philippine Consulate for
Imported Product
6. Valid Government Certificate attesting to the status of the manufacturer,
competency and reliability of the personnel and facilities or valid ISO
Certification for Imported Product. For imported products, certificate must be
and duly authenticated by the territorial Philippine Consulate
7. Copy of latest Certificate of Product Registration
8. Certificate of Foreign Agency Agreement between the manufacturer and
trader/distributor/importer regarding the product involved duly authenticated
by the territorial Philippine Consulate
9. Intended use and Directions for Use
10. List of all raw materials used as components of the reagents/test kit
11. Technical specifications and physical description of the Finished Product
12. Process-control/Test Procedure and expected performance specification
13. Brief description of the methods used in the facility and the controls in the
manufacture, processing, packaging of the IVD and the process flowchart
showing an overview of production
14. Risk analysis with control measures
15. A. For INITIAL: Stability test data and results describing the shelf life, in-use
stability, and the shipping stability studies to justify claimed shelf life. The
testing should be performed on at least three (3) different product lots
manufactured under conditions that are essentially equivalent to routine
production conditions.
B. For RENEWAL: Stability test data and results describing the shelf life.
The testing should be performed on at least three (3) different product lots
manufactured under REAL TIME CONDITION.
16. A. For INITIAL: Labeling materials to be used for the product: Immediate
label, secondary packaging, box label and package insert/brochure.
B. For renewal, submit clear and readable commercial product label specimen
of all labeling materials (outer, immediate, package insert)
17. For pregnancy test kit, 15 samples of the same lot with at least nine (9)
months expiration date. For other IVD applications, samples will be submitted
directly to the respective NRLs. No. of samples required will depend on the
requirement of each NRL.
18. Evidence of registration fee/payment (charge slip/official receipt)
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TYPE OF
APPLICATION
INITIAL RENEWAL
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N/A

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Application should be filed six (6) months prior to the expiration of the validity of the CPR.
Submit an electronic/scanned copy (in PDF searchable format of at least 150dpi).
The soft copy should be arranged according to the checklist of requirements. The file name should consist of the
name of the requirement. The electronic copy should be contained either in one single continuous file per
requirement or single continuous file for all requirements.
Bring hard copy of the assessment slip.
 
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