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Assessment Sheet Initial MD

FDA medical device registration sheet form for assessment per requirements for the registration of medical devices

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: QWP-CDRRHR/LRD-02 Annex 08
Rev. No. 01 Date Effective: 18 October 2017

ASSESSMENT SHEET AS PER CHECKLIST OF REQUIREMENTS FOR THE
REGISTRATION OF MEDICAL DEVICES
Name of product _______________________________________________________________________
Company Name & Address _______________________________________________________________
Evaluator _____________________________________________________________________________
Date Evaluated _________________________________________________________________________
REQUIREMENTS
YES
NO
REMARKS

1. Table of Contents (with page number)
2. Notarized Application form from Distributor (Importer/Exporter/
Wholesaler)/Local Manufacturer/Trader
3. Valid License to Operate (LTO) of Distributor (Importer/Exporter/
Wholesaler)/Local Manufacturer/Trader
4. 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
5. 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 duly authenticated by the territorial
Philippine Consulate.
6. Valid Certificate of foreign agency agreement between the
manufacturer and trader/distributor/importer regarding the product
involved duly authenticated by the territorial Philippine Consulate.
7. Specific Use and Directions/Instruction for Use
8. List of all raw materials used as component of the product and its
technical specifications. Must include quantity and detailed
information on physical and chemical properties of each component.
9. Brief description of the methods used the facilities and control in the
manufacture, processing and packaging of the product. For sterile
products, include sterilization standard parameters, sterilization
procedures, validation protocol and results of latest sterilization
validation with sterility tests. If the sterilization of the device was
contracted out, submit copy of valid ISO of the contracted sterilizing
company.
10. Technical specifications and physical description of the Finished
Product. Submit also the following: (a) Functionality/performance
test data & results conducted on the finished product; (b)Test data and
results of the Biocompatibility test of the device being registered; (c)
Risk analysis and control of the device, if applicable
11. Stability study of the product duly signed by the person who
conducted the studies to justify claimed expiration date. For
accelerated study, submit computation to justify the storage condition
used. If no expiration, submit justification from the manufacturer why
the device has no expiration.
12. Labeling materials for all sizes/reference codes to be used for the
product: Immediate label, secondary packaging, box label and package
insert/brochure, whichever is applicable
13. Representative sample (as needed) and clear colored photo of the
actual commercial product sample without its packaging
14. Evidence of registration fee/payment (charge slip/official receipt)
 
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