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.
November 6, 2025
Approximately 5 minutes
Technical Overview: The FDA ANDA Process for Generic Drug Approval
Technical Overview: ANDA Approval Process (Simplified)
The Abbreviated New Drug Application (ANDA) under Section 505(j) of the FD&C Act allows approval of a generic drug by demonstrating pharmaceutical equivalence and bioequivalence (BE) to a Reference Listed Drug (RLD).
1. RLD Identification & Pre-Submission Assessment
- Select the RLD from the Orange Book.
- Evaluate formulation sameness (Q1/Q2) where required, especially for complex products.
- Review exclusivities, perform patent certifications (Paragraph I–IV), and check suitability requirements (21 CFR 314.93).
2. Formulation & CMC Development
- Develop a formulation that is pharmaceutically equivalent to the RLD and aligned with its quality attributes.
- Perform risk assessments per ICH Q8–Q11.
- Establish a control strategy including API characterization, polymorph form, particle size, and excipient compatibility.
3. Analytical Method Development & Validation
- Develop and validate stability-indicating analytical methods as per ICH Q2(R2).
- Conduct method robustness and transfer readiness studies.
- Perform impurity profiling (ICH Q3A/Q3B), evaluate residual solvents (ICH Q3C), and assess elemental impurities (ICH Q3D).
4. Bioequivalence (BE)
- Conduct in-vivo BE studies per 21 CFR 320, or request a BCS-based biowaiver when applicable.
- Use partial or full replicate designs for highly variable drugs.
- Demonstrate BE using pharmacokinetic parameters with 90% CI falling within 80–125%.
5. Stability Studies
- Perform real-time and accelerated studies per ICH Q1A(R2).
- Generate stability data for exhibit/commitment batches, covering all critical quality attributes.
6. ANDA Dossier Preparation (CTD Format)
- Module 1: Administrative information, patent certifications (Paragraph I–IV), and labeling (PLR format).
- Module 2: Quality overall summaries (QOS).
- Module 3: CMC sections for drug substance (3.2.S) and drug product (3.2.P), including characterization, specifications, validation, container closure details, and batch results.
- Module 4: Nonclinical data (only if needed).
- Module 5: BE/biowaiver data.
7. ANDA Submission Under GDUFA
- Submit application via eCTD.
- Pay GDUFA application and facility fees.
- FDA begins filing review, CMC evaluation, labeling review, BE assessment, and facility inspection planning.
8. FDA Interactions
- Respond to Information Requests (IRs), Discipline Review Letters (DRLs), or Complete Response Letters (CRLs).
- Address inspection observations (Form 483) and implement CAPA as needed.
- Ensure proper DMF linkage and maintain a valid Letter of Authorization.
9. Approval or Tentative Approval
- Final Approval: Issued when all scientific requirements are met and no patent/exclusivity barriers exist.
- Tentative Approval: Issued when scientific review is complete but approval is blocked by existing exclusivity.
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US FDA Establishment Registration and Device Listing (FURLS) Requirements
Annual **Establishment Registration** and **Device Listing** with the US FDA is mandatory for most facilities involved in manufacturing, importing, or reprocessing devices for the US market. Registration is completed via the online **FURLS** system, and listing is generally required unless the entity is an Initial Importer.
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.
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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.