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PFDA Registration Requirementfor Class A

This document outlines the legal requirements for applying for notification or registration of medical devices in the Philippines. It lists 6 requirements including a notarized application form, payment, documents from the manufacturer like a letter of authorization and quality certificate, and pictures of the device. It also provides the technical requirements for class A medical device notification, which include a device description, certificates of conformity if applicable, declaration of conformity to standards, pictures of product labels, and a declaration of shelf life.

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Rosenda Monette
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59 views

PFDA Registration Requirementfor Class A

This document outlines the legal requirements for applying for notification or registration of medical devices in the Philippines. It lists 6 requirements including a notarized application form, payment, documents from the manufacturer like a letter of authorization and quality certificate, and pictures of the device. It also provides the technical requirements for class A medical device notification, which include a device description, certificates of conformity if applicable, declaration of conformity to standards, pictures of product labels, and a declaration of shelf life.

Uploaded by

Rosenda Monette
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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AINNEX A

Legal Requirements foru Application for the Notification of Medical Devices under
Class A and Registration of Medical Devices under Classes 8, C and D

1. Notarized Application Form (Amex G or H)


2. P ayment
3. Copy of Letter of Authorization. For imported medical devices, the copy of
the Letter of Authorization shall be accompanied by an original copy of a
notarized declaration from the legal manufacturer or product owner attesting
that the authorization is tnre and correct.
4. A government -issued certificate attesting to the status of the Manufacturer
with regard to the competence and reliability of the persomel and facilities,
a Quality Systems Certificate Of approval, or a compliance certificate for ISO
13485. For inported medical devices, the copy of the cedficate shall be
accompanied by an original copy of a notarized declaration from the legal
manufacturer or product owner attesting that the certificate is true and
correct.
5. For imported medical devices, the Gatifi.cate_+]fJhoduct-Notification,
Certificate of Product Registration, or any equivalent document attesting to
the safety and effectiveness of the device issued by the regulatory agency or
accredited notified body in the country of origin. The copy of the certificate
shall be accompanied by an oririnal copy of a notarized declaration from the
legal manufacturer or product owner attesting that the certificate is true and `;
correct.
6. Colored picture of the device from all sides. However, the CDRRIIR can
require a representative sample or commercial presentation for verification
purposes.

ANNEX 8

Technical Requirements for Application for the Notification of Medical Devices


under Class A

1. Device description consisting of the following:


a. Intendeduse
b. Instruction for use
c. List ofall raw materials
d. Technical specification of the finished product
e. List of reference codes, sizes, colors, models and variance, whichever
is applicable.
2. Certificate of Conformity (issued by goverrment agency dealing with
metrology) on the aspect of manufacture relating to metrology for devices
with measuring functions, if applicable
3. Declaration of Conformity (self declaration by the manufacturer) \prth
product standards, if applicable
4. Clear and complete colored pictures oflal]el from all sides of the packaging
(loose label or artworks of all layers of packaging)
5. Declaration of shelf life

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