Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Qualtech Consulting Corporation
Taiwan, China, Japan, Singapore, Hong Kong, Malaysia, Philippines, Vietnam, Australia, Germany, Korea, Thailand, USA
A specialized medical device consulting firm offering a one-stop solution for complex global regulatory challenges. We offer real-time regulatory and clinical support, local representation, and QMS services across 13 markets, ensuring efficient market entry and compliance.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
December 2, 2024
Approximately 5 minutes
US FDA Establishment Registration and Device Listing (FURLS) Requirements
US FDA Establishment Registration and Device Listing (FURLS)
Any establishment involved in the production, importation, reprocessing/relabeling, or developing specifications of a medical device or In Vitro Diagnostic (IVD) product for commercial sale in the United States must register annually with the U.S. Food and Drug Administration (FDA).
1. Establishment Registration
Establishment Registration is a mandatory, yearly process that is separate from obtaining a pre-market submission clearance (like 510(k) or PMA approval).
Who Must Register? As a general rule, any facility that manufactures all or part of a medical device sold in the U.S., or performs processing activities such as sterilization, must register.
The registration is completed through the FDA’s online Facility Establishment Registration and Device Listing (FURLS) system. A critical step is the payment of appropriate annual fees, which must be completed before the registration process can proceed.
2. Device Listing
In addition to registering the establishment, the FDA requires registered facilities to list the specific devices they manufacture or process. This listing is done using the Device Registration and Listing Module (DRLM) within the FURLS system.
Initial Importer Exemption An important exception exists for the Initial Importer. An Initial Importer is responsible for furthering the marketing of a foreign-manufactured device entering the U.S. to the final distributor. While Initial Importers must register their establishment, they are not required to list the devices they import.
When registering and listing, facilities must accurately identify the device Product Code and classification, which for new products often requires an initial assessment or relies on information provided in the 510(k) clearance letter.
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Approximately 5 minutes
US FDA Clearance Pathways: Classification, QSR, and the 510(k) / PMA Process
All medical and IVD devices for sale in the US must follow the FDA's regulatory process, which involves risk-based classification (Class I, II, III), compliance with the Quality System Regulation (QSR), and securing premarket authorization through 510(k) or Premarket Approval (PMA).
Approximately 5 minutes
US FDA Medical Device Classification: Risk-Based System and Pathways for Novel Devices
The US FDA classifies medical devices into Class I, II, or III based on risk, using a predicate-based system. Most Class II devices require a 510(k), while Class III requires Premarket Approval (PMA). Novel devices lacking a predicate may pursue classification via a 513(g) Request or the De Novo pathway to avoid automatic Class III status.
Approximately 5 minutes
Understanding the FDA Q-Submission (Q-Sub) Process and Pre-Submission Guidance
The FDA's Q-Submission (Q-Sub) process, primarily used as a **Pre-Submission (Pre-Sub)**, allows medical device manufacturers to receive formal, non-mandatory regulatory feedback from FDA experts *before* submitting their 510(k), PMA, or IDE application. This early dialogue is crucial for novel or high-risk devices.
Approximately 5 minutes
How Long is the FDA Review Process for 510(k) Medical Device Submissions? (MDUFA III Goals)
The FDA's goal, per MDUFA III, is to issue a final clearance decision for most 510(k) submissions within **90 calendar days**. Key milestones include acceptance review within 15 days and substantive review decisions within 60 days, providing manufacturers with a predictable communication timeline.
Approximately 5 minutes
US Medical Device Clearance: The Predicate Pathway and FDA's Regulatory Philosophy
The US FDA emphasizes different regulatory barriers than the EU. The **510(k) pathway** often allows clearance based on demonstrating **substantial equivalence** to a predicate device, representing a distinct philosophy focused on comparative safety and effectiveness rather than the continuous, stricter clinical evaluation required by the EU MDR.
Approximately 5 minutes
Technical Overview: The FDA ANDA Process for Generic Drug Approval
The Abbreviated New Drug Application (ANDA) is the FDA pathway (Section 505(j)) for generic drug approval, requiring demonstration of **pharmaceutical equivalence** and **bioequivalence (BE)** to a Reference Listed Drug (RLD). The process involves RLD identification, Q1/Q2 formulation, BE studies, stability testing, and eCTD submission under GDUFA.