Pre-Assessment Form of Requirements For Certificate of Medical Device Registration (CMDR) - Class B Legal Requirements 1. Notarized Application Form

Republic of the Philippines
Department of Health
Food and Drug Administration
Filinvest Corporate City
Alabang, City of Muntinlupa
-
QWP-CDRRHR/LRD-14 Annex 07
Revision No. 01 Date Effective: 15 March 2021
PRE-ASSESSMENT FORM OF REQUIREMENTS FOR CERTIFICATE OF MEDICAL DEVICE

REGISTRATION (CMDR) – CLASS B
LEGAL REQUIREMENTS
Documentary Requirements Yes No Remarks
1. Notarized Application Form
Company Name:
Product Name :
Manufacturer :
 Completely filled-up
 Product Name consistent across all the application
documents.
 NAF is unedited, non-tampered, and is the latest
document posted.
 Brand name and medical device name are correct.
 Device risk-classification is correct.
 For medical device having multiple codes –
inclusion of an annex accompanying the NAF
containing all the codes in the application.
 Verify LTO number and date of notary.
2. Copy of Notarized Agreement/ Letter of Authorization
 Valid
 The product being applied must be indicated.
 For imported medical devices, with notarized
declaration from the legal manufacturer or product
owner attesting that the authorization agreement is
true and correct
 For imported medical devices but the agreements
are signed in the Philippines, it must be notarized
locally, with passport ID page and record of arrival
and departure of the principal to and from the
Philippines of the signatory/ies, and must be signed
by both parties.
 For open-dated agreements/authorizations, if the
certificate is beyond 5-year period, re-issued
agreement/ authorization must be submitted or a
notarized attesting by the Principal that the
agreement/authorization is still in effect.
 For locally manufactured medical devices with
exclusive distributors, the agreement should be duly
notarized.
 For locally manufactured medical devices with toll
manufacturer. Agreement between the trader and
the manufacturer should be duly notarized.
 Red ribbon/ apostille: Acceptable if issued/dated on
or before September 2020.
 Attestation of notary instead of notarized
declaration from the manufacturer.
3. For imported Medical Devices – a copy of
government issued certificate attesting to the status of
the manufacturer with regard to the competence and
reliability of the personnel and facilities, a Quality
System Certficate of approval, or a compliance
certificate for ISO 13485.
 Valid
 Accompanied by a notarized declaration from the
legal manufacturer or product owner attesting that
the certificate is true and correct.
 For products that are manufactured in multiple sites
or toll manufacturer, identify or highlight product
source.
 The product being applied must be indicated in the
scope.
 For locally manufactured products, valid LTO of the
manufacturer.
 Attestation of notary instead of notarized declaration
from the manufacturer.
4. For medical devices, 1 copy of the Certificate of
Product Registration, CE Certificate or any
equivalent documents attesting to the safety and
effectiveness of the device issued by regulatory
agency or accredited notified body in the country
of origin.
 Must be valid
 Accompanied by a notarized declaration from the

legal manufacturer or product owner attesting that
the certificate is true and correct.
 Attestation of notary instead of notarized declaration
from the manufacturer.
 US FDA 510k and PMA (Post Marketing Approval)
 Singapore HAS: Online registry
5. Clear colored picture of the actual commercial

product sample of the device for all sided without its
packaging
 Pictures should not be pixelated when the view
increased in size/ zoomed in.
TECHNICAL REQUIREMENTS
Documentary Requirements Yes No Remarks
1. Executive Summary: Executive summary shall
include the following information:
 An overview, e.g., introductory descriptive
information on the medical device, the intended
uses and indications for use of the medical device,
any novel features and a synopsis of the content
of CSDT;
 Commercial marketing history
 Intended uses and indications in labelling
 List of regulatory approvals or marketing
clearance obtained
 Status of any pending request for marketing
clearance
 Safety/performance related information.
2. Relevant essential principles and method/s
used to demonstrate conformity, if applicable
(see annex K)
3. Device description with the following
information:
 Intended use
 Indication of use
 Instruction for use
 Contraindications
 Warnings
 Precautions
 Potential adverse effects
 Alternative therapy (practices and procedures)
 A. Materials: A description oof the materials of
the device and their physical properties to the
extent necessary to demonstrate conformity with
the chemical, biological and physical
characterization of the materials of the device.
A.1 Functional characteristics and technical
performance specifications of the device
including, as relevant: accuracy, sensitivity,
specificity or measuring and diagnostic medical
devices, reliability, and other factors.
A.2 If, applicable, other specifications including
chemical, physical, electrical, mechanical,
biological, software, sterility, stability, storage
and transport, and packaging.
4. Summary of Design Verification and
Validation Documents:
The validation documents shall consist of the

following:
 Declaration/certificate of conformity to the
product standards issued by the manufacturer.
 Summary or reports of the tests and evaluation
based on the other standards, manufacturer
methods and tests, or alternative ways of
demonstrating compliance, such as a listing of and
conclusions drawn from published reports that
concern the safety and performance aspects of the
medical device with reference to the essential
principles.
 Data summary or tests reports and evaluation
covering the following appropriate test reports,
whichever is applicable
a. Engineering test
b. Laboratory test
c. Biocompatibility test
d. Animal test
e. Simulated test
 Clinical evidence
 Software validation studies (if applicable)
 Biological evaluation (if applicable)
 Bibliography of all published reports dealing with
the use, safety, and effectiveness of the device.
5. Clear and complete colored pictures of label
from all sides of the packaging (loose label or
artworks of all layers of packaging)
6. 2 representative samples per SKU
7. Risk assessment consisting of risk analysis,
evaluation and reduction measures.
8. Physical Manufacturing Information
 Manufacturing process, including quality
assurance measures. This should include the
manufacturing methods and procedures,
manufacturing environment or conditions,
facilities and controls. The information ma be
presented in the form of a process flow chart
showing an overview of production, controls
assembly, final product testing, and packaging of
finished medical device.
 A brief summary of sterilization method

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Republic of the Philippines

PRE-ASSESSMENT FORM OF REQUIREMENTS FOR CERTIFICATE OF MEDICAL DEVICE

 Accompanied by a notarized declaration from the

 Singapore HAS: Online registry

5. Clear colored picture of the actual commercial

The validation documents shall consist of the

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