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The Center for Device Regulation, Radiation Health, and Research (CDRRHR) under the leadership of Director Maria Cecilia Credo Matienzo initiated the conduct of the 1st CDRRHR Kapihan, at Talakayan for CY 2024 on 05 April 2024 at the FDA Conference Hall, Alabang, Muntinlupa City wherein 75 members of the medical device industry participated in the event. This activity is a form of formal consultations with selected stakeholders, aiming to collect recommendations and exchange ideas with medical device stakeholders for the improvement of regulatory policies and procedures.

Director Matienzo delivers her opening remarks, followed by discussion and presentation of the Updates on Medical Device Regulations focusing on FDA Circular No. 2024-005: The Extension the Regulatory Flexibility for Class B, C, and D Medical Devices. The discussion is followed by an “Open Forum” wherein the stakeholders ask questions and clarifications regarding the regulatory policies and procedures of FDA- CDRRHR. Director Matienzo patiently responded in each and every question, concerns and inquiries.

On the last part of the said event, Director Matienzo delivers her closing remarks, to wit: “The success of regulation does not rely alone on government regulators. Regulation should be a hand-in-hand effort of the government regulators, manufacturers, distributors, end-users and the general public.”

“The manufacturers should comply with the standards set to develop and to manufacture the device in accordance with the set regulations, the distributors should ensure that products are registered prior to distribution, the end-users should only buy registered products and ensure that they are well capacitated to use the device products, the general public to ensure to be vigilant and report unregistered products in the market, and the regulators to ensure clear and efficient regulatory policies, guidelines, procedures and processes.” Director Matienzo emphasized.


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