PRE-ASSESSMENT EVALUATION FORM

(CMDN) – CLASS A

DOCUMENTARY REQUIREMENTS YES NO REMARKS

Notarized Agreement
a. The product being applied must be
indicated.

Name of product: Doppler (Mizuho) 

Name of Applicant: Fixus
Enterprises

b. For imported medical devices, with

notarized declaration from the  Kindly submit notarized
legal manufacturer or product declaration from the legal
owner attesting that the manufacturer attesting that
the
authorization/agreement is true and
authorization/agreement is
correct true and correct.
For Imported Medical Devices - Government issued certificate attesting to the status of the
Manufacturer with regard to the competence and reliability of the personnel and facilities, a Quality
Systems Certificate of approval, or a compliance certificate for ISO 13485.
a. Must be valid. 

b. Copy of the certificate shall be 

accompanied by a notarized
declaration from the legal
manufacturer or product owner
attesting that the certificate is true
and correct.
c. The product being applied must be 
indicated in the scope
For imported medical devices, Certificate of Product Notification, Certificate of Product
Registration, or any equivalent document attesting to the safety and effectiveness of the device
issued by the manufacturer (Self-Declaration), regulatory agency or accredited notified body in the
country of origin.
a. Must be valid.  Please take note that
free sale certificate is
not accepted as
substitute for
Certificate of product
registration equivalent
b. The Copy of the certificate shall be 
accompanied by a notarized
declaration from the legal
manufacturer or product owner
attesting that the certificate is true
and correct
Clear colored picture of the actual commercial product sample of the device for all sides without its
packaging. However, CDRRHR can require a representative sample or commercial presentation for
verification purposes
a. Is this available? 

Device Description consisting of the following:

 a. Intended use – this should include 
the specific use of the product
being applied. If the product is part
of the system, the specific use of
the product as part of the system
should be indicated and not the
intended use of the system.
b. Instruction for use – this is the 
detailed instruction for use for the
users of the medical device. The
instruction should be clear enough
to guide its users
c. List of raw materials – this should  Submit as separate file
include all the raw materials as
component of the medical device
itself.
d. Technical specification of the  Submit as separate file
finished product – This should
include the technical specification
of the finished products (physical,
chemical, mechanical, electrical,
etc.). This maybe in the form of
Certificate of Analysis or Test
certificate
Certificate of Conformity (issued by government agency dealing with metrology) on the aspect of
manufacture relating to metrology for devices with measuring functions, if applicable i.e. Weighing
Scale, etc.
a. Is this available? NA NA Submit “certificate of non-
coverage” stating that the
product has no measuring
function and therefore not
covered by the
requirements.
Declaration of Conformity with product standards (self-declaration by the manufacturer).
a. These are the standards used 
during the design, development,
manufacture, testing of the medical
devices
b. The standards to be considered are 
Philippine National Standards
(PNS), international standards
(ISO, IEC) and other equivalent
national standards (of these
international standards)
Clear and complete colored pictures of label from all sides of the packaging (loose label or
artworks of all layers of packaging)
a. Immediate label, secondary 
packaging, box label and package
insert/brochure, whichever is
applicable.
b. For any additional product claims on 
the label, submit studies or tests
supporting the claims
c. For imported products, if the brand 
name is the product’s local brand,
declaration from the manufacturer
 allowing use of the brand name and
IPO approval of the said brand name
Declaration of Shelf life
a. Is this applicable? N/A

NOTE:
 For local manufactured products, IPO approval of the said brand name.
 If a CE marking is reflected on the label, submit valid certificate supporting the placement of the CE
mark.
 Pictures and text of the label should be clear and will not be pixelated when the view is increase in
size.
 Lot No., Batch No., Serial No., whichever is applicable should be reflected
 Expiration date, reference codes/sizes/variants/model whichever is applicable should be reflected.
 Storage condition, sterilization method should be reflected if applicable.
 Importer and distributor’s name and address should be reflected in the label of the product together
with the Registration No.