Revised Policies on the Application for Automatic Renewal of Certificate of Product Registration for Medical Devices
FDA Memorandum Circular No. 012-13 outlines the revised policies for the automatic renewal of Certificates of Product Registration (CPR) for medical devices, excluding in-vitro diagnostics. Applications must be submitted to the Center for Device Regulation, Radiation Health, and Research (CDRRHR) at least 90 days before the CPR's expiration, with specific documentation required. Approved renewals will be valid for five years, and applications should be processed within 30 days. Late applications filed within 120 days post-expiration may incur fees, while those submitted after this period will require initial registration. This circular supersedes a previous memorandum and became effective on April 15, 2013.
Quick Answers
- What is Revised Policies on the Application for Automatic Renewal of Certificate of Product Registration for Medical Devices about?
- FDA Memorandum Circular No. 012-13 outlines the revised policies for the automatic renewal of Certificates of Product Registration (CPR) for medical devices, excluding in-vitro diagnostics. Applications must be submitted to the Center for Device Regulation, Radiation Health, and Research (CDRRHR) at least 90 days before the CPR's expiration, with specific documentation required. Approved renewals will be valid for five years, and applications should be processed within 30 days. Late applications filed within 120 days post-expiration may incur fees, while those submitted after this period will require initial registration. This circular supersedes a previous memorandum and became effective on April 15, 2013.
- What type of law is FDA Memorandum Circular No. 012-13?
- Revised Policies on the Application for Automatic Renewal of Certificate of Product Registration for Medical Devices (FDA Memorandum Circular No. 012-13) is a Philippine Other Rules and Procedures enacted by the Congress of the Philippines.
- When was Revised Policies on the Application for Automatic Renewal of Certificate of Product Registration for Medical Devices enacted?
- Revised Policies on the Application for Automatic Renewal of Certificate of Product Registration for Medical Devices (FDA Memorandum Circular No. 012-13) was enacted on Apr 8, 2013.
- What is the citation for Revised Policies on the Application for Automatic Renewal of Certificate of Product Registration for Medical Devices?
- Revised Policies on the Application for Automatic Renewal of Certificate of Product Registration for Medical Devices, FDA Memorandum Circular No. 012-13, Apr 8, 2013 (Philippines)
Law Information
- Reference Number
- FDA Memorandum Circular No. 012-13
- Date Enacted
- Category
- Other Rules and Procedures
- Subcategory
- Food and Drug Administration
- Jurisdiction
- Philippines
- Enacting Body
- Congress of the Philippines
Full Law Text
April 8, 2013
FDA MEMORANDUM CIRCULAR NO. 012-13
| SUBJECT | : | Revised Policies on the Application for Automatic Renewal of Certificate of Product Registration (CPR) for Medical Devices Excluding In-Vitro Diagnostic Products |
With the complete transfer of the regulatory functions for medical device products from the Food and Drug Administration, Alabang to Center for Device Regulation, Radiation Health, and Research (CDRRHR) by virtue of the Republic Act No. 9711 known as the FDA Act of 2009, the following revised policies on the application for automatic renewal of Certificate of Product Registration shall be implemented:
1. All Certificates of Product Registration (CPR) shall be covered by this memorandum except for in-vitro diagnostic products.
2. Applications for the automatic renewal of CPR shall be filed at the Center for Device Regulation, Radiation Health, and Research (CDRRHR) at least ninety (90) days before the expiration of the CPR.
3. The requirements for the application for automatic renewal of the CPR shall be as follows:
a. Duly accomplished notarized application form (Doc. No. 011-004-R-02B)
b. Duly accomplished assessment form (Doc. No. 011-004-R-03C)
c. Copy of valid LTO
d. Original copy of CPR EScHDA
e. Copy of authenticated foreign agency agreement
f. Copy of ISO/GMP Certification
g. Unattached commercial product label and specimen labeling of all labeling materials per pack size (immediate label, secondary, carton, package insert, etc., whichever is applicable). If unattached labels are not available, a picture of the label (all angles/sides) of all layers of packaging showing clearly all the labeling requirements can be submitted.
h. Clear picture of commercial product sample (Bring the actual sample for verification).
4. The filing of applications shall follow FDA Memorandum Circular No. 2013-001 as amended by FDA Memorandum Circular No. 2013-001-A (e-copy).
5. The schedule of filing of applications shall follow FDA Memorandum No. 2012-008.
6. All approved applications for renewal of CPRs shall be reissued and shall have a validity of five (5) years.
7. All applications for automatic renewal shall be processed within thirty (30) days upon filing. An application that complies with all the requirements shall merit an approval and the CPR shall be reissued and shall have a validity of five (5) years. An application that did not comply with all the requirements shall be given a notice of deficiency.
8. An application filed within one hundred twenty (120) days after the expiration date of the CPR shall still qualify for the renewal of the CPR following the above mentioned requirements. However, corresponding fees and surcharges shall be imposed as per Administrative Order No. 50 s. 2001 and FDA Memorandum Circular No. 2011-004. IaEASH
9. An application filed after the one hundred twenty (120) days grace period shall be considered an application for initial registration and the applicant shall not be allowed to market the product unless the new CPR is approved.
This memorandum circular supersedes BHDT Bureau Memorandum No. 2011-001 dated June 10, 2011.
This memorandum shall take effect on April 15, 2013.
(SGD.) KENNETH Y. HARTIGAN-GO, MDDirector General
Cite This Law
Revised Policies on the Application for Automatic Renewal of Certificate of Product Registration for Medical Devices, FDA Memorandum Circular No. 012-13, Apr 8, 2013 (Philippines)
Revised Policies on the Application for Automatic Renewal of Certificate of Product Registration for Medical Devices, FDA Memorandum Circular No. 012-13 (Phil. 2013)
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- Guidelines for the Issuance of a Conditional Certificate of Product Registration for Veterinary Products with Initial Registration with the BFADBFAD Bureau Circular No. 15-06 • Oct 18, 2006 • Other Rules and Procedures
- Policies and Guidelines Governing the Registration and Licensing of Establishments Dealing with Medical DevicesDOH Administrative Order No. 2007-0003 • Jan 8, 2007 • Other Rules and Procedures
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