MEDICAL DEVICE

REGISTRATION
Dr. Jose Jacinto D. Cordero
Regulatry Affairs Specialist
GOVERNING LAW

FDA CIRCULAR 2020-001 FDA CIRCULAR 2020-001A

INITIAL FINAL IMPLEMENTATON

IMPLEMENTATION OF OF ADMINISTRATIVE
ADMINISTRATIVE ORDER ORDER 2018-002
2018-0002

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RISK CLASSIFICATION

ADMINISTRATIVE ORDER 2018-2002

GUIDELINES GOVERNING ISSUANCE OF AN
AUTHORIZATION FOR A MEDICAL DEVICE BASED ON
THE ASEAN HARMONIZED TECHNICAL
REQUIREMENTS

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MEDICAL DEVICE CLASSIFICATION

LOW LOW-MODERATE
e-portal e-submission

MODERATE – HIGH HIGH

e-submission e-submission

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MEDICAL DEVICE REGISTRATION
REQUIREMENTS
(CLASS A)

PART I
LEGAL REQUIREMENTS
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I. NOTARIZED AGREEMENT

▰ Product being applied must be indicated.

▰ Name of Applicant
▰ Should be accompanied by notarized
declaration from the supplier/principal that
the agreement is true/authentic and correct.

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II. QMS CERTIFICATE OR ISO 13485

▰ Must be valid.
▰ Product being applied must be indicated in the
scope.
▰ Should be accompanied by notarized
declaration from the supplier/principal that the
certificate is true/authentic and correct.

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III. PRODUCT REGISTRATION EQUIVALENT

▰ Must be valid.
▰ Certificate of Medical Device Notification.
▰ Certificate of Product Registration.
▰ Should be accompanied by notarized
declaration from the supplier/principal that
the certificate is true/authentic and correct.

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“ FREE SALE CERTIFICATE
(FSC) is not accepted as
product registration equivalent.

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IV. PRODUCT PHOTO

▰ Clear, colored picture of the commercial

product sample from all sides without the
packaging.

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MEDICAL DEVICE REGISTRATION
REQUIREMENTS
(CLASS A)

PART II
TECHNICAL REQUIREMENTS
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I. INTENDED USE

▰ Must indicate the specific use of product

being appplied.
▰ If 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

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II. INSTRUCTION FOR USE

▰ Detailed instruction for use for the users of

the medical device.
▰ The instruction should be clear enough to
guide the users.

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III. LIST OF RAW MATERIALS

▰ This should include all the raw materials as

component of the medical device itself.

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IV. TECHNICAL SPECIFICATIN OF 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.

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V. 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.
▰ If not applicable, a notarized declaration should be
submitted that the product being applied for has no
measuring function
▰ Must be accompanied by a notarized declaration that
the certification/ self declaration is true and correct.

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VI. DECLARATION OF CONFORMITY
(MANUFACTURERS SELF DECLRATION)

▰ These are the standards used during the design,

development, manufacture, testing of the medical
devices.
▰ The standards to be considered are Philippine
National Standards (PNS), international standards
(ISO, IEC) and other equivalent national standards
(of these international standards
▰ Must be accompanied by a notarized declaration that
the certification/ self declaration is true and correct.

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VII. ARTWORK AND LABELING MATERIALS

▰ Clear colored pictures of labels from all sides.

▰ Immediate label, secondary packaging, box label and
package insert/brochure, whichever is applicable.
▰ For any additional product claims on the label,
submit studies or tests supporting the claims.
▰ 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.
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VII. SHELF-LIFE

▰ For product with shelf-life, submit stability studies to

support the claim.
▰ For product without shelf-life, submit a notarized
declaration/ certification that the product has no
shelf-life and therefor not covered by the
requirement. This must be accompanied by notarized
declaration that the declaration/ certification is true
and correct.
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“ ADDITIONAL NOTES

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▰ 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
▰ 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.

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 THANKS!Any questions?
You can reach me at
09175928646
josejacintodesdircordero@gmail
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