Regulatory Q&A Forum
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As foreign medical device manufacturers navigate the transition to the FDA's new Quality Management System Regulation (QMSR) ahead of its February 2, 2026 effective date, how does this fundamental shi...
With evolving regulatory expectations for post-market surveillance and vigilance (PMSV) in the European Union, particularly concerning upcoming reporting updates, many medical device manufacturers are...
For non-EU/EEA companies manufacturing substances, preparing mixtures, or producing articles that will be placed on the European market, compliance with the REACH (Registration, Evaluation, Authorisat...
When evaluating the cost of appointing an EU Authorized Representative for the Carbon Border Adjustment Mechanism (CBAM), what are the key service components and risk factors that manufacturers should...
When non-EU manufacturers enter the European market, they often need an in-market entity to fulfill specific regulatory obligations. While roles like the EU Authorized Representative (AR) for medical ...
For foreign medical device establishments, the U.S. Agent serves as a critical link to the FDA, but their responsibilities extend far beyond initial registration. As regulatory expectations evolve, ho...
While the core legal responsibilities of an FDA U.S. Agent—serving as a communication link between the FDA and a foreign manufacturer—are not directly altered by the new Quality Management System Regu...
For medical device manufacturers preparing for updated Post-Market Surveillance and Vigilance (PMSV) reporting requirements, selecting an external Person Responsible for Regulatory Compliance (PRRC) s...
Given the EU MDR's mandate for a Person Responsible for Regulatory Compliance (PRRC) under Article 15, and with updated Post-Market Surveillance and Vigilance (PMSV) reporting forms anticipated by Mar...
For a Class II software-enabled device, such as an integrated continuous glucose monitoring system (iCGM), what specific documentation artifacts should a sponsor prepare to comprehensively address FDA...
For non-EU medical device manufacturers placing products on the European market, appointing an EU REACH Only Representative (OR) is often a critical step for chemical compliance. Given that medical de...
When developing a novel pharmacogenetic assessment system, a Class II device regulated under 21 CFR § 862.3364, what is a comprehensive framework for preparing a premarket submission that meets FDA's ...
For international manufacturers of clinical diagnostics, appointing a U.S. Agent is a mandatory step for market entry, but what distinguishes a purely administrative agent from a truly strategic regul...
When foreign medical device manufacturers evaluate the cost of retaining an FDA U.S. Agent, what key factors beyond a basic annual fee should be considered to ensure a compliant and effective partners...
With the EU's planned update to Post-Market Surveillance and Vigilance (PMSV) reporting forms anticipated for March 2026, how should medical device manufacturers strategically evaluate a third-party "...
For a medical device manufacturer navigating chemical compliance in the European Union, selecting the right Only Representative (OR) is a critical strategic decision. With the regulatory landscape con...
When developing a novel Class II in-vitro diagnostic (IVD) test system, especially one intended for prognostic use or risk assessment for conditions such as acute kidney injury, sponsors must navigate...
When a medical device manufacturer develops a novel Class II in vitro diagnostic (IVD), general controls alone may be insufficient to provide a reasonable assurance of safety and effectiveness. In the...
Given the critical role of the Person Responsible for Regulatory Compliance (PRRC) under the EU MDR, and with upcoming changes to Post-Market Surveillance and Vigilance (PMSV) reporting forms anticipa...
Given the evolving regulatory landscape, how can a medical device manufacturer effectively demonstrate a robust, total product lifecycle (TPLC) approach to cybersecurity within a premarket submission?...