Requirements for Certificate of Registration for Medical Devices

1) A valid LTO or License to Operate which can be obtained from the FDA

2) A clear, scanned, and colored copy of loose labels of all packaging sizes for
the products (or equivalent, as defined by FDA), as well as pictures of the
product from all angles and in different packaging sizes. This allows easy
recognition of a product as the same one being registered.

 For food supplements, include blister packs, Alu-Alu packs, and secondary
packaging (i.e. paper box or cardboard box).
3) Other requirements for traders, wholesalers, and distributors of locally
manufactured food products / for importers and distributors

4) Documents to support product claims, such as:

 Technical/nutrition health studies or reports

 Market research studies
 Certificate of analysis, quantitative analysis, and computations
 Scientific reports or studies published in peer-reviewed scientific journals
 Supporting certificates to allow the use of “Sangkap Pinoy”, Halal, Organic,
Kosher, and other claims in compliance with current labeling requirements
5) Certificate of Analysis stating essential details to determine product
compliance to food standards and regulations for the following:

 Medium to high-risk products with standards of identity such as food for

infants and young children, foods intended for special medical purposes,
bottled water, etc) the certificate of analysis must be uploaded. The list of
low, medium, and high risks can be found here on the FDA website.
 Fortified food products covered by R.A. 8176 (iodized salt) and R.A. 8976
(cooking oil, flour, and refined sugar)
6) For food supplements, additional requirements include:

 A stability study of the actual food supplement

 Safety data, such as toxicity tests, must be attached to address safety
concerns regarding the product.
7) Actual representative product sample of food supplement (for initial application
only, and is not needed during CPR renewal).