2. GOVERNING LAW
FDA CIRCULAR 2020-001
INITIAL IMPLEMENTATION OF
ADMINISTRATIVE ORDER 2018-
0002
FDA CIRCULAR 2020-001A
FINAL IMPLEMENTATON OF
ADMINISTRATIVE ORDER
2018-002
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3. RISK CLASSIFICATION
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ADMINISTRATIVE ORDER 2018-2002
GUIDELINES GOVERNING ISSUANCE OF AN AUTHORIZATION
FOR A MEDICAL DEVICE BASED ON THE ASEAN HARMONIZED
TECHNICAL REQUIREMENTS
6. 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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7. 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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8. 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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12. 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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13. 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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14. III. LIST OF RAW MATERIALS
▰ This should include all the raw materials as
component of the medical device itself.
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15. 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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16. 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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17. 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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18. 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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19. 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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21. 21
▰ 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.
