Commodity

Commodity Details

For Imports

Regulating Agencies

Legal Basis

• Administrative Order No. 2020-0017 – Administrative Order No. 2020-0017 || Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003
• DOH Department Circular No. 2011-0101 – DOH Department Circular No. 2011-0101 The Rules and Regulations Implementing RA No. 9711- The Food and Drug Administration Act of 2009
• Republic Act No. 10611 – Republic Act No. 10611 An Act To Strengthen The Food Safety Regulatory System In the Country To Protect Consumer Health And Facilitate Market Access Of Local Foods And Food Products And For Other Purposes
• Republic Act No. 7394 dated April 13, 1992 – Republic Act No. 7394 dated April 13, 1992 The Consumer Act of the Philippines
• Republic Act 9711 dated August 18, 2009 – Republic Act 9711 dated August 18, 2009 An Act Strengthening And Rationalizing The Regulatory Capacity Of The Bureau Of Food And Drugs (BFAD) By Establishing Adequate Testing Laboratories And Field Offices, Upgrading Its Equipment, Augmenting Its Human Resource Complement, Giving Authority To Retain Its Income, Renaming It The Food And Drug Administration (FDA), Amending Certain Sections Of RA No. 3720, As Amended, And Appropriating Funds Thereof

Permits, Clearances, Certifications

• License to Operate (LTO)
• Certificate of Product Registration (CPR)
• FDA Certification/Notification/Clearance (for those not requiring LTO and/or CPR)
• Certificate of Analysis (if applicable)

Requirements & Procedures

Documentary Requirements

Food and Drug Administration

1. 1. Valid LTO as Medical Device Importer
   1. Notarized Petition Form and Joint Affidavit of Undertaking
   2. Notarized Electronic Copy of Affidavit
   3. List of Medical Devices to be imported/distributed
   4. Photocopy of the Pharmacist's Board Registration Certificate, PRD-ID, valid PTR, Duties and Responsibilities, Certificate of Attendance of Owner/Pharmacists to a FDA Seminar on Licensing of Drug/Medical Device Establishments and Outlets
   5. Location plan and floor plan (office and storage room/warehouse) with dimensions
   6. Photocopy of the Business Name Registration
   7. if single proprietorship, registration from the DTI
   8. if corporation/partnership, registration from SEC and Articles of Incorporation
   9. ID pictures of Owner/Authorized Representative and Pharmacist (size 5 cm x 5 cm)
   10. Photocopy of notarized valid Contract of Lease for the space of the office and storage to be occupied or any proof of ownership if it is owned by the applicant
   11. Foreign Agency Agreement with each supplier/source duly authenticated by the Territorial Philippine Consulate
   12. Certificate of Registration of the Manufacturer and its conformity with GMP issued by a Government Health Authority or valid ISO Certification for Medical Device and duly authenticated by the Territorial Philippine Consulate

   *In addition to the hard copy of the abovementioned requirements, the client shall also submit an electronic copy (in PDF searchable format at least 300 dpi) on a DVD-R of the applicants

2. Valid CPR
   1. Notarized Application Form
   2. Notarized Electronic Copy (e-copy) Affidavit
   3. Valid License to Operate
   4. Government Certificate of Clearance and Free Sale/Registration approval of the product from the country of origin issued by the Health Authority and duly authenticated by the territorial Philippine Consulate for Imported Products
   5. Government Certificate attesting to the status of the manufacturer, competency and reliability of the personnel and facilities or valid ISO Certification for Imported Product. For Imported products, certificate must be duly authenticated by the territorial Philippine Consulate
   6. Certificate of Foreign Agency Agreement between the manufacturer and importer regarding the product involved duly authenticated by the territorial Philippine Consulate
   7. Specific Use and Directions/Instruction for Use
   8. List of all raw materials used as component of the product and its technical specifications. Must include quantity and detailed information on physical and chemical properties of each component
   9. Brief description of the methods used, the facilities and control in the manufacture, processing and packaging of the product. For sterile products, include sterilization standard parameters, sterilization validation with sterility tests. If the sterilization of the device was contracted out, submit copy of valid ISO Certificate of the contracted sterilizing company.
   10. Technical specifications and physical description of the Finished Product. Submit also the following: (a) Functionality/performance test data & results conducted on the finished product; (b) test data and results of the Biocompatibility test of the device being registered; (c) Risk analysis and control of the device, if applicable
   11. Stability studies of the product, at least 3 trials, duly signed by the person who conducted the studies to justify claimed expiration date. If no expiration, submit declaration from the manufacturer why the device has no expiration
   12. Labeling materials for all sizes/reference codes to be used for the product: Immediate label, secondary packaging, box label and package insert/brochure, whichever is applicable

   *In addition to the hard copy of the abovementioned requirements, the client shall also submit an electronic copy (in PDF searchable format at least 300 dpi) on a DVD-R of the application.

Procedures

Food and Drug Administration

1. Application form id downloaded from www.fda.gov.ph
   • The integrated application form in XLS or XLSX format is used for both License and Registration applications, as well as amendments and other certifications. Promos and advertisements are also now covered in the application from. Remember that a valid LTO is required for a CPR.
2. Application form is filled-up correctly.
   • The application form has six parts:
     1. General Information
     2. Establishment Information
     3. Product Information
     4. Supporting Information
     5. Sources and Clients
     6. Applicant Information
   • If the part is appropriately filled up, a green 'PROCEED' will be indicated. Required fields will appear sequentially. If the form is appropriately filled up, the composed body text (in the green box) will appear.
3. Send an email to pair at pair@fda.gov.ph
   • In the XLS application form, the worksheet 'Email' composes the subject and bosy of the email that should be sent to pair@fda.gov.ph. Copy and paste the appropriate fields onto the email. Include CCs as needed. The XLS or XLSX file should not be attached but it will be required during submission. Any attachment will lead to rejection of schedule request. Up to ten applications in a single email are acceptable.
4. Within two working days, a Document Tracking Log (DTL) is sent with a schedule for submission.
   • The FDA will determine the schedule of applications according to the priority of the Centers. A quota will be set for the total number of applications that can be scheduled in a day. Multiple applications sent in a single email may be scheduled over separate days. Requests for specific schedules will not be accommodated. Receiving will be scheduled within 10 working days of receipt of application email.
5. Fees are paid either at Land Bank branches or at the main FDA cashier.
   • Once a DTL is received, payment can be made immediately through any branch of the Land Bank of the Philippines. The main FDA cashier will only accommodate those scheduled to be received for the day. A copy of the DTL provided by FDA and a copy of the application form are required to process payment. Indicate in the application form the tracking number provided. Check that the tracking number indicated in the DTL is indicated in the proof of payment.
6. Check if all requirements are in order.
   • Be sure that you have a checklist of requirements and that you have all the necessary documents. Don't forget to have the petition or declaration form notarized. A softcopy of all requirements should be stored in a USB device to facilitate transfer. Include an XLS or XLSX copy of the accomplished application form. Please keep your USB devices free of malicious software. A copy of the OnColl Payment Slip is also required at the point of submission.
7. Application is filed on schedule.
   • Only applications scheduled for the day will be accommodated. Hard copies will no longer be required at submission. Don't forget to get back the USB devices used to transfer documents. Remember the RSN number of each application. Use the RSN to follow-up through pair@fda.gov.ph. Should you fail to complete submission on the set date, queue for another schedule through pair@fda.gov.ph using RSN.

NTMs

1. FDA – License to Operate
2. FDA – Certificate of Product Registration
3. FDA – Labelling Requirement

Import Status

Regulated

For Exports

Regulating Agencies

Status

The export of this commodity is currently regulated. Please contact the regulating agency above for export requirements and procedures.

NTMs

1. FDA – License to Operate
2. FDA – Certificate of Product Registration
3. FDA – Export Certification

Tariff Schedules

Visit the Philippine Tariff Commission (TC) through its Philippine Tariff Finder (PTF).

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