Medical Device Registration in Philippines

Medical Device Registration in Philippines

May 2021: Class A list

Jan 2021: All remaining class B C D medical devices update

As of Jan 2021, all medical devices (not IVD) now require Registrations (CMDR) or Notification (CMDN) in the Philippines. Previously, only Class A and certain listed Class B, C, and D devices require registration or notification.

The COE would remain valid until November 3, 2021, or for 2 years from issuance date, whichever comes first.

Notifications can be completed in about a month.

Notifications would only be valid for 2 years. Manufacturers would then need to submit a new CMDR application 3 months before expiry of Notifications.

It is highly recommended to start your Notification or Registration process to maintain market access.

FDA-Circular-No.2021-002

Click here to go to Philippines FDA website.

For the latest applicable Medical Device in Philippines regulations, please get it from below.

A0-2018-002

Circular No.2020-001

Contact us here for more information on Medical Device registration in Philippines.

Requirements for Medical Device Registration in Philippines

Letter of Authorization (the copy of the Letter of Authorization shall be accompanied by an original copy of notarized declaration from the legal manufacturer or product owner attesting that the authorization is true and correct.)

A government issued certificate attesting to the status of the Manufacturer with regard to the competence and reliability of the personnel and facilities, a Quality Systems Certificate of approval, or a compliance certificate for ISO 13485 (the copy of the certificate shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting that the certificate is true and correct.)

Certificate of Product Registration or any equivalent document attesting to the safety and effectiveness of the device issued by the regulatory agency or accredited notified body in the country origin. (The copy of the certificate shall be accompanied by an original copy of a notarized declaration from the legal manufacturer or product owner attesting the certificates is true and correct.)

Executive Summary
The executive summary shall include the following information:
a. an overview, e.g., introductory descriptive information on the medical device, the intended uses and indications for use of the medical device, any novel features and a synopsis of the content of the Common Submission Dossier Template (CSDT);
b. the commercial marketing history;
c. the intended uses and indications in labeling;
d. the list of regulatory approvals or marketing clearances obtained;
e. the status of any pending request for market clearance;
f. the important safety/performance related information.

Relevant essential principles and method/s used to demonstrate conformity

Device Description with the following information:
a. Intended use
b. Indications of use
c. Instruction for use
d. Contraindications
e. Warnings
f. Precautions
g. Potential adverse effects
h. Alternative therapy (practices and procedures)
i. Materials. A description of the materials of the device and their physical properties to the extent necessary to demonstrate conformity with the relevant Essential Principles. The information shall include complete chemical, biological and physical characterization of the materials of the device.
j. Other Relevant Specifications to include the following:

1) The functional characteristics and technical performance specifications of the device including, as relevant: accuracy, sensitivity, specificity of measuring and diagnostic medical devices, reliability, and other factors
2) If applicable, other specifications including chemical, physical, electrical, mechanical, biological, software, sterility, stability, storage and transport, and packaging.
k. Other Descriptive Information to demonstrate conformity with the relevant Essential Principles (e.g. biocompatibility category for the finished medical device)

Summary of Design Verification and Validation Documents:
a. Declaration/Certificates of Conformity to the “internationally recognized standards” issued by the manufacturer
b. Summaries or reports of tests and evaluation based on other standards, manufacturer methods and tests, or alternative ways of demonstrating compliance, such as a listing of and conclusions drawn from published reports that concern the safety and performance of aspects of the medical device with reference to the Essential Principles
c. Data summaries or tests reports and evaluations covering the following appropriate test reports, whichever is applicable:

1. Engineering test
2. Laboratory test
3. Biocompatibility test
4. Animal Test
5. Simulated Use
6. Software Validation
7. Pre-clinical studies

Clear and complete coloured pictures of label in all angles of the packaging (loose label or artworks of all layers of packaging).

Risk Analysis and the results of this analysis

Physical Manufacturer information
a. Manufacturing process, including quality assurance measures. This should include the manufacturing methods and procedures, manufacturing environment or conditions, facilities and controls. The information may be presented in the form of a process flow chart showing an overview of production, controls, assembly, final product testing, and packaging of finished medical device.
b. A brief summary of the sterilization method should be included.

Commercial sample for FDA verification purposes

Frequently Asked Questions for Medical Device Registration in Philippines

Can there be more than one license holder (Importer) in Philippines?

Yes

Can the license be transfer?

Yes but with the cooperation from existing license holder.

Contact

Contact us here for more information on Medical Device Registration in Philippines.