Third-Party Regulatory Approval

Overview

As a safety science company, UL has the experience, local contacts and global industry expertise to help you understand and meet regulatory requirements to bring medical devices to market globally.

Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries. This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality.
Definition

Some regulatory bodies designate third parties to provide approvals for specific types of products before they are allowed to be sold and/or used in the specific regulator's area of responsibility.

Benefits

UL provides the health sciences industries with end-to-end regulatory and certification services for global markets, including:

Japan: As a Recognized Certification Body under the Japan PAL third-party program, UL can provide regulatory approvals of qualified devices. And UL-qualified auditors can integrate the Japan Quality requirements into your ISO 13485 audit, saving your customers time and resources.

Europe: Work with local Notified Body auditors -- a Notified Body is an accredited organization recognized by the European Union to audit quality systems and test devices to applicable standards and directives -- to gain an objective and impartial assessment of your quality management system and technical file(s), by using UL as your Notified Body.


DELIVERABLES

Written summary or report of findings that covers topics assessed


PRODUCTS THIS SERVICE APPLIES TO

Medical and IVD devices

APPLICABLE STANDARDS

U.S. Food and Drug Administration (FDA) / Center for Devices and Radiological Health (CDRH) Federal agency responsible for premarket approval of medical devices and specific non-medical electromagnetic radiating devices
European Commission Governing body proposing, implementing and enforcing EU policies, legislation, and law
MHLW / PMDA Ministry of Health, Labour and Welfare / Pharmaceutical and Medical Devices Agency

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