DDReg Knowledge Capsule
DDReg Knowledge Capsule is a short-form podcast from DDReg Pharma that covers trends, innovations, and challenges across the life sciences industry. Each episode breaks down complex topics such as regulatory affairs, pharmacovigilance, market access, and clinical development into clear, accessible discussions. The show is hosted by experts from DDReg and is aimed at pharma professionals who want practical, up-to-date insight. Episodes are designed as quick, focused capsules that can be followed alongside a busy working schedule.
Episodes
Dietary Supplement Registration in Brazil vs. Mexico ANVISA and COFEPRIS Market Entry Pathways
"Welcome to the DDReg Knowledge Capsule" — This episode explores the contrasting regulatory pathways for entering the dietary supplement markets in Brazil and Mexico. It compares ANVISA's mandatory notification system in Brazil with COFEPRIS's compliance-focused framework in Mexico, detailing essential requirements for product classification, ingredient eligibility, local labelin
Strategic Regulatory Intelligence: Turning Regulatory Signals into Product Decisions
DDReg Knowledge Capsule, discover how pharmaceutical leaders move beyond passive regulatory monitoring to build a decision-oriented strategy that directly shapes product development. Learn how evaluating global health authority updates through product-specific context enables teams to assess impacts across clinical trials, CMC, dossier submissions, and post-approval lifecycles—ensuring every strat
South Korea KDMF Requirements for Imported APIs
Welcome to the DDReg Knowledge Capsule" — This episode provides a practical overview of South Korea's Korea Drug Master File (KDMF) registration framework managed by the Ministry of Food and Drug Safety (MFDS) for imported active pharmaceutical ingredients (APIs). It explains how to determine registration scope, adapt global technical packages (such as US DMFs, ASMFs, or CEPs) to satisfy
Regulatory Data Quality: The Hidden Risk Behind Submission & Compliance
Regulatory success depends on more than an accurate dossier. In today’s data-driven pharmaceutical environment, inconsistent product information across submissions, labeling, regulatory databases, and lifecycle activities can create submission delays, regulatory queries, rework, and compliance risks.In this episode, we explore why Regulatory Data Quality has become a critical priority for pharmace
Pharmacovigilance Launch Readiness For Marketing Authorization Holders
Welcome back to the DDReg Knowledge Capsule! In this episode, we explore how Marketing Authorization Holders (MAHs) build and maintain compliant Pharmacovigilance (PV) governance structures as products transition to commercialization.We break down the core operational components of PV systems, including Qualified Person for Pharmacovigilance (QPPV) services, Individual Case Safety Report (ICSR) pr
The Strategic Role of Regulatory Affairs in Pharma Industry
In this edition of the DDReg Knowledge Capsule, we explore how Regulatory Affairs guides medicinal products from early research through market authorization and post-approval lifecycle management. Learn how RA teams establish global regulatory strategies, coordinate complex submissions, manage health authority interactions, and leverage digital tools to accelerate approval timelines while maintain
Global Biosimilar Pathways 2026 : US, EU, UK & Asia
Welcome to the DDReg Knowledge Capsule!In this episode, we unpack the rapidly changing global regulatory landscape for biosimilar development across key target markets: the US (FDA), European Union (EMA), UK (MHRA), China (NMPA/CDE), and Japan (PMDA).We examine the pivotal 2026 transition away from routine comparative clinical efficacy trials toward tailored, risk-based evaluation frameworks groun
Registering Biosimilar Drugs with Health Canada
Welcome to DDReg Knowledge Capsule! In this episode, we explore Health Canada's regulatory framework for registering biosimilar biologic drugs. We break down the fundamental differences between biosimilars and generic small-molecule drugs, explain why biosimilars are authorized through the New Drug Submission (NDS) pathway, and discuss the pivotal role of the Canadian Reference Biologic Drug (
Global Regulatory Operating Model For Pharma Leaders
This episode explores how pharmaceutical organisations can effectively structure regulatory roles across global, regional, and local markets. Based on the DDReg guide to global regulatory operating models, the discussion highlights the strategy of "controlled decentralization"—maintaining global consistency for core scientific positions while ensuring local authority ownership where juri
Mastering Global CMC Variations & Life Cycle Management
Welcome to DDReg Knowledge Capsule! In this episode, we dive into the complex world of global post-approval change management in the pharmaceutical industry.When a drug product undergoes a single internal scientific or manufacturing modification—such as a site transfer, process modification, or analytical method update—it can trigger dozens of distinct regulatory submissions across international j
Malaysia NPRA 2026: Fast Route for Biosimilar Registration
Welcome to the DDREG Knowledge Capsule. In this episode, we unpack the National Pharmaceutical Regulatory Agency's (NPRA) landmark 2026 reliance pilot pathway in Malaysia. We explore how eligible biosimilars with prior US FDA or EMA approval can now access an accelerated 60-working-day registration timeline.However, this rapid timeline is far from automatic. We break down the strict parameters
Mandatory EUDAMED Compliance for German Medical Devices 2026
Welcome to this episode of the DDReg Knowledge Capsule. In this session, we break down Germany's critical regulatory transition from the national DMIDS database to the EU-wide EUDAMED platform. We explore the operational modules that became mandatory on 28 May 2026—including Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance—and clarify the
India's Pharma Shift from Generics to Innovation
India is evolving from "the pharmacy of the world" to a powerhouse of pharmaceutical innovation, focusing on biosimilars, complex generics, and advanced therapies. In this episode, we unpack how this transition is fundamentally reshaping global regulatory strategies, clinical trial expectations, and FDA compliance for companies targeting international marketsVisit our blog for more: http
Why Gene Therapy Manufacturing Fails FDA
Why do even the most revolutionary gene therapies with promising clinical results face critical roadblocks on their path to commercial approval? In this episode of the DDReg Knowledge Capsule, we delve deep into the core reasons behind Biologics License Application (BLA) delays, focusing on common Chemistry, Manufacturing, and Controls (CMC) pitfalls, weak analytical strategies, and limited compar
Navigating the UAE's MOHAP to EDE Transition
Welcome to the DDReg Knowledge Capsule. In this episode, we unpack the historic shift in the UAE’s healthcare regulatory framework as the Emirates Drug Establishment (EDE) takes over medical device oversight from the Ministry of Health and Prevention (MOHAP). Established under Federal Decree-Law No. 38 of 2024, the EDE centralizes compliance across all seven emirates. We discuss critical updates f
Jordan Joins PICS Pharmaceutical Inspection Scheme
Welcome to the DDReg Knowledge Capsule! In this episode, we explore the major regulatory milestone of 1 January 2026, when the Jordan Food and Drug Administration (JFDA) became the 57th Participating Authority of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).As only the second Arab nation to achieve full PIC/S membership, Jordan is significantly boosting its standing as a reliable phar
AI in Regulatory Affairs: What It Can and Can’t Do in 2026
Welcome to the DDReg Knowledge Capsule. In this episode, we cut through the industry hype to examine exactly what AI can and cannot do in 2026. Learn why AI struggles with complex, judgment-dependent tasks like clinical risk-benefit assessments, novel product pathway determinations, and health agency negotiations. We map out a practical task classification framework—distinguishing between AI-led,
NAFDAC Drug Registration: Nigeria Market Access Guide (2026)
This Podcast about Nigeria has emerged as one of Africa’s most dynamic pharmaceutical markets, but for global manufacturers, the path to entry is defined by the rigorous oversight of the National Agency for Food and Drug Administration and Control (NAFDAC). In this episode, we move beyond the theory of registration to explore the operational realities of the Nigerian market.We break down the criti
The RaaS Revolution in Pharma 2026
In this episode, we explore why pharmaceutical companies are moving away from traditional internal departments and adopting Regulatory-as-a-Service (RaaS). We break down how this agile model provides on-demand access to global regulatory expertise and advanced technology—such as AI-powered dossiers and autonomous compliance agents—while significantly reducing fixed overhead costs. Tune in to learn
Winning Thailand FDA Priority Drug Approvals
Welcome to the DDReg Knowledge Capsule. In this episode, we demystify the Thailand FDA Priority Review, a process that functions more as a controlled acceleration mechanism than a straightforward fast track. While many sponsors expect a simple path to market, we explore why dossier maturity, therapeutic justification, and submission coherence are the true deciders of speed.For more details - https
Egypt EDA Drug Approval and Registration Guide
This episode explores why Egypt is a top priority for regional expansion, boasting a pharmaceutical sector valued at approximately USD 5.9 billion.We dive into the regulatory framework established by Law No. 151 of 2019, which transitioned authority to the Egyptian Drug Authority (EDA).The discussion covers the essential 10-step authorization process, the mandatory requirement for a locally licens
Navigating TGA Australia Drug Registration and Compliance
This episode provides a comprehensive guide to the Therapeutic Goods Act 1989, exploring the various pathways for getting prescription medicines onto the Australian Register of Therapeutic Goods (ARTG). We dive into the differences between Standard, Verification, and Priority Review pathways, while highlighting the critical importance of Australian-specific documentation, such as the Australian Sp
Global Orphan Drug Designations: Building a Cross-Market Strategy
In this episode of the DDReg Knowledge Capsule, we explore the strategic importance of building a comprehensive, multi-market regulatory approach for rare disease treatments. While orphan drug frameworks in the US, EU, Japan, and Australia share the goal of incentivising development for niche populations, they differ significantly in their prevalence thresholds, eligibility criteria, and financial
Sri Lanka’s 2026 Medical Device Regulatory Registration
In this episode, we explore the significant transformation of the medical device landscape in Sri Lanka under the mandate of the NMRA. We break down the risk-based classification system—from low-risk Class One items like bandages to the high-risk apex of Class Three devices like cardiac stents. Learn how international manufacturers can leverage the Global Recognition Pathway to fast-track approval
South Korea MFDS Drug Registration: 2026 Updates and Approval Guide
This episode explores the significant 2026 updates to the Ministry of Food and Drug Safety (MFDS) drug registration process in South Korea. We dive into the relaxation of mandatory domestic clinical trials in favour of multinational Phase 3 data, the expansion of the conditional approval pathway for innovative medicines, and the increasing alignment of biosimilar frameworks with international stan
2026 SFDA Roadmap: Mastering Pharmaceutical Registration in Saudi Arabia
In this episode of the DDReg Knowledge Capsule, we explore the regulatory complexities of entering the Middle East’s largest pharmaceutical market, currently valued between $10.5 and $12.3 billion. We break down the SFDA’s comprehensive registration process, from the mandatory appointment of a Saudi Authorized Representative (SAR) to the technical nuances of submitting eCTD-compliant dossiers.The
How To Winning the ANVISA Drug Registration Race
This podcast, Episode [32], introduced with the "DDReg Knowledge capsule" greeting, provides a deep dive into the complexities of pharmaceutical registration in Brazil. It explores the central role of ANVISA (National Health Surveillance Agency) and the specific regulatory pathways designed to accelerate market entry, such as Priority Review and the Reliance and Expedited Pathway. The di
The Blueprint for Effective Pharmacovigilance SOPs
Welcome to this episode of the DDReg Knowledge Capsule, Episode [31] where we explore the critical role of Standard Operating Procedures (SOPs) as the foundation of a reliable pharmacovigilance (PV) system. This discussion highlights how well-written SOPs transform global regulatory requirements from agencies such as the EMA, FDA, and CDSCO into actionable workflows that ensure patient safety and
Indonesia's Pharma Market: BPOM Drug Registration Decoded
📢 DDReg Knowledge Capsule – Episode [30]This podcast provides an in-depth analysis of Indonesia's regulatory landscape, the largest pharmaceutical market in Southeast Asia, with a population exceeding 270 million. It details the methodical and documentation-intensive drug registration process managed by the National Agency of Drug and Food Control (BPOM). Key insights include the mandatory req
The WHO Global Strategy on Digital Health 2027 Framework
📢 DDReg Knowledge Capsule – Episode [29]The shift in global healthcare as digital tools move from experimental pilots to core national infrastructure. It highlights the collaborative roles of the World Health Organisation (WHO), which defines the strategic policy framework, and the Global Initiative on Digital Health (GIDH), which manages the practical implementation and funding. The 2027 strategy
Regulatory Impact of Manufacturing Site Transfers
📢 DDReg Knowledge Capsule – Episode [28]This podcast covers the analysis of the regulatory complexities involved when relocating production facilities for pharmaceuticals, biologics, and medical devices. Moving a manufacturing site is not a simple logistical task but a significant material change that requires specific approvals and notifications across different global jurisdictions. The text hig
Post-Market Clinical Follow-Up: Regulatory Obligations and Documentation Strategies
📢 DDReg Knowledge Capsule – Episode [27]This podcast covers Post-Market Clinical Follow-up (PMCF) under the European Union’s Medical Device Regulation (MDR). It describes how manufacturers must transition from passive monitoring to a continuous, proactive process of gathering clinical data throughout a product’s entire lifecycle. The source outlines the necessity of creating defensible documentati
Ethnic Sensitivity Factors in Global Drug Development
📢 DDReg Knowledge Capsule – Episode [26]This podcast cover about how ethnic sensitivity influences the creation and approval of pharmaceuticals on a global scale. It highlights that biological differences, such as genetics and metabolism, alongside extrinsic factors like diet and environment, can significantly alter a medication’s safety and performance. To address these variations, regulatory bod
Mandating Bridging Studies Under ICH E5 Regulatory Criteria
📢 DDReg Knowledge Capsule – Episode [25]This podcast cover about ICH E5 guidelines mandate bridging studies when foreign clinical data cannot reliably predict a drug's safety or efficacy in a local population. Requirements depend on ethnic sensitivity, including intrinsic genetic factors, extrinsic medical practices, and PK/PD differences.https://resource.ddregpharma.com/blogs/bridging-studies
Cultural Nuances in Global Adverse Event Reporting
📢 DDReg Knowledge Capsule – Episode [24]How cultural influences create significant discrepancies in adverse event reporting and patient-reported outcomes within global pharmacovigilance. It highlights that inconsistencies in safety data often stem from social norms, language barriers, and varying levels of health literacy rather than just regulatory failures. The source warns that these nuances ca
Scaling Quality Compliance and Audits Across Global Networks
📢 DDReg Knowledge Capsule – Episode [23]importance of maintaining rigorous oversight of external vendors within the international pharmaceutical and medical device sectors. It explains that regulatory bodies hold the primary product owners directly accountable for any quality failures, regardless of where manufacturing or material sourcing occurs. To mitigate these risks, the source advocates for
🧬 Clinical Trial Design Strategies for Advanced Therapies
📢 DDReg Knowledge Capsule – Episode [22]Designing clinical trials specifically for advanced medicinal products such as gene and cell therapies. Because these treatments possess unique biological complexities, the source emphasizes that standard drug development frameworks are often insufficient and require specialised regulatory alignment. It highlights the importance of using adaptive dosing stra
Advanced FMEA in Medical Device Lifecycle Management
📢 DDReg Knowledge Capsule – Episode [22] Failure Mode and Effects Analysis (FMEA) as a dynamic tool for managing medical device risks throughout their entire lifespan. Rather than treating it as a one-time paperwork requirement, the source advocates for a comprehensive framework that evolves alongside design, manufacturing, and real-world usage. It details how different types of analysis, such as
10 Rules For 2026 Life Sciences Approvals
📢 DDReg Knowledge Capsule – Episode [21] Integration of Artificial Intelligence and the establishment of digital trust. It asserts that the pervasive use of AI in functions like pharmacovigilance and R&D has led to an erosion of digital trust, necessitating that automated systems be audited with the same rigor as traditional validated processes. Regulatory authorities now require demonstrable
FDA 510(k) Submission Process Guide for 2026
📢 DDReg Knowledge Capsule – Episode [20] Integration of Artificial Intelligence and the establishment of digital trust. It asserts that the pervasive use of AI in functions like pharmacovigilance and R&D has led to an erosion of digital trust, necessitating that automated systems be audited with the same rigor as traditional validated processes. Regulatory authorities now require demonstrable
AI Auditability: The Foundation of Digital Trust in Pharma
📢 DDReg Knowledge Capsule – Episode [20]Integration of Artificial Intelligence and the establishment of digital trust. It asserts that the pervasive use of AI in functions like pharmacovigilance and R&D has led to an erosion of digital trust, necessitating that automated systems be audited with the same rigor as traditional validated processes. Regulatory authorities now require demonstrable t
The Regulatory Nexus: Borderline Product Classification
📢 DDReg Knowledge Capsule – Episode [19]These products, which often exhibit characteristics overlapping categories like medicines, medical devices, and food supplements, present a significant challenge because misclassification carries substantial compliance risks and can severely delay market entry. Regulatory authorities determine the necessary classification pathway—which dictates obligations s
Hong Kong's Mandatory Medical Device Registration Transition
📢 DDReg Knowledge Capsule – Episode [18]Hong Kong is transitioning from the Medical Device Administrative Control System (MDACS), a voluntary listing mechanism, to a new statutory mandatory registration system. This significant shift is driven by the Department of Health’s goal to strengthen patient safety and align with mature international regulatory frameworks by requiring comprehensive technic
eCTD 4.0: Redefining Regulatory Submission Strategy and Digitization
📢 DDReg Knowledge Capsule – Episode [17]The significant global shift toward eCTD 4.0 for regulatory dossier submissions in the pharmaceutical industry. This new standard moves regulatory management from static files to a data-driven connected information system, emphasising features like a unified XML backbone, unique document identifiers (UUIDs), and controlled vocabularies. The article outlines
The Essential Role of the EU QPPV in Pharmacovigilance
📢 DDReg Knowledge Capsule – Episode [16]Role of the Qualified Person Responsible for Pharmacovigilance (QPPV) in the European Union (EU). It clarifies that the QPPV services is a legally mandated strategic leader for every Marketing Authorisation Holder, continuously ensuring the safety and benefit-risk profile of marketed medicines in line with EU pharmacovigilance (PV) legislation. The article d
Combination Products: Global Regulatory Convergence and Complexity
📢 DDReg Knowledge Capsule – Episode [15]The regulatory landscape for combination products in 2025, defining them as items where drugs, devices, or biologics combine for a single therapeutic effect, such as insulin pens. It highlights the rapid growth of this market, which is projected to reach USD 251.9 billion by 2030, reflecting both innovation and regulatory challenges. The text contrasts the g
AI Reshaping Pharmacovigilance Signal Detection and Case Management
📢 DDReg Knowledge Capsule – Episode [14]How Artificial Intelligence (AI) is fundamentally transforming the field of pharmacovigilance (PV), specifically in case management and signal detection. It explains that AI technologies, such as Natural Language Processing (NLP) and Machine Learning (ML), are moving drug safety surveillance from a slow, manual, and reactive process to a proactive and predic
Pharmacovigilance for Cell and Gene Therapies
📢 DDReg Knowledge Capsule – Episode [13]This Podcast explains that because CGTs are transformative but complex, specialised pharmacovigilance (PV) is essential throughout the entire product lifecycle, from preclinical evaluation to long-term follow-up (LTFU), which can extend up to 15 years. The text outlines key components of PV, including risk assessment, clinical safety monitoring for events li
AI Utility in Regulatory Intelligence: Beyond the Hype
📢 DDReg Knowledge Capsule – Episode [12]Discusses the application of Artificial Intelligence (AI) in Regulatory Intelligence (RI), seeking to differentiate the genuine utility of the technology from industry hype. It defines RI as the process of evaluating regulatory data to support strategic decision-making and compliance, particularly within sectors like pharmaceuticals and medical devices. The
mRNA Technology: Expansion Beyond Vaccines
📢 DDReg Knowledge Capsule – Episode [11]while the COVID-19 pandemic accelerated mRNA visibility, its scope now includes cancer immunotherapies, treatments for genetic and metabolic disorders, and regenerative medicine, with the global market projected for significant growth. The text also outlines both the key benefits of mRNA, such as speed and versatility, and the inherent challenges, including
UAE Pharma Gateway: A Guide to UAE Pharmaceutical Registration
The United Arab Emirates is one of the Middle East's fastest-growing pharmaceutical markets, offering a strategic gateway for global manufacturers But entering this lucrative market requires navigating a complex regulatory landscape.In this episode, we unpack the essential guidelines for the drug product registration process in UAE. We explore the roles of the two key regulatory authorities: t
Pharmacovigilance in New Zealand
📢 DDReg Knowledge Capsule – Episode [9]Overview of pharmacovigilance in New Zealand, highlighting the regulatory framework overseen by Medsafe under the Medicines Act 1981. It explains that the country participates in the WHO International Drug Monitoring Programme and uses systems like the Suspected Medicine Adverse Reaction Search (SMARS) database to gather post-market safety information. The te
PV Inspection Guide For Your Auditing Mastery in FDA and EMA
📢 DDReg Knowledge Capsule – Episode [9]pharmacovigilance (PV) inspections preparedness, conducted globally by regulatory bodies to ensure compliance among marketing authorization holders. These inspections, which can be announced or unannounced, verify that systems, facilities, and processes adhere to PV requirements and aim to identify non-compliance that could potentially harm patients. The arti
Mexico Drug Registration Process via COFEPRIS
📢 DDReg Knowledge Capsule – Episode [8]In-depth guide to the drug registration process in Mexico, highlighting its importance as the second-largest pharmaceutical market in Latin America. The core of the process is overseen by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), which categorises medicines into distinct regulatory pathways, such as New Chemical Entities and
New Drug Approval Roadmap According to CDSCO
📢 DDReg Knowledge Capsule – Episode [8]In this podcast, we cover the steps and points that any global and local entity should follow when planning to register their new drug product in the Indian market.
Pharma Packaging Revolution in EU PPWR
📢 DDReg Knowledge Capsule – Episode [7] In-depth analysis of the European Union’s Packaging and Packaging Waste Regulation (EU PPWR), officially designated as Regulation (EU) 2024/1781, which replaces a previous directive to mandate stricter sustainability standards across the EU. This new regulation, which entered into force in February 2025, aims to prevent waste, ensure all packaging is recy
Translational Biology Accelerating Tomorrow's Therapies
📢 DDReg Knowledge Capsule – Episode [6]Introduces the concept of Translational Biology and explains how this field is accelerating the development of new therapies by creating a continuous feedback loop between laboratory discovery and patient care. The article outlines the multi-stage Translational Biology Pipeline (T0 to T4), which moves findings from basic research through clinical trials and
Biosimilar Safety in 2025 | Your Strategic Pharmacovigilance Checklist
📢 DDReg Knowledge Capsule – Episode [6]Strategic Pharmacovigilance Checklist for Biosimilar Safety in 2025," which offers guidance on managing the increasing complexities of biosimilar safety. The article explains that the biosimilar market is rapidly expanding, necessitating robust pharmacovigilance (PV) to ensure patient safety and mitigate risks. It presents a comprehensive checklist cover
China Pharma Market Innovation Regulation and Global Impact
📢 DDReg Knowledge Capsule – Episode [5]Overview of the drug approval process in the Chinese pharmaceutical market, highlighting its significance as the world's second-largest. It details the types of drugs approved, including innovative medicines, generics, and traditional Chinese medicines, and identifies the key regulatory bodies, namely the National Medical Products Administration (NMPA) an
Staying Vigilant When the Patient Volume Is Low
📢 DDReg Knowledge Capsule – Episode [5]Low data doesn’t mean low risk. In this episode, we unpack how PV teams detect signals in low-volume markets, using smarter tools, sharper strategies, and local expertise to keep drug safety ahead of the curve. For mor Visit our bloghttps://resource.ddregpharma.com/blogs/signal-detection-in-low-volume-markets-how-smart-pv-teams-stay-ahead/
Medical Device Cybersecurity
📢 DDReg Knowledge Capsule – Episode [4]This DDReg Knowledge Capsule focuses on cybersecurity in connected medical devices, highlighting the critical balance between technological advancement and patient safety. It discusses the evolving landscape of cyber threats and the regulatory frameworks put in place by bodies like the FDA and the Department of Health and Human Services to address these risks
How On-the-Spot Testing Brings Care Closer
📢 DDReg Knowledge Capsule – Episode [3]In this episode of the DDReg Knowledge Capsule,introduce point-of-care diagnostics (POC) as a rapidly expanding sector within the in-vitro diagnostics industry. It explains that POC devices facilitate quick medical testing near the patient, leading to faster diagnoses and improved outcomes, particularly in situations where resources are limited.
How Apps Are Changing the Way We Manage Chronic Illness
📢 DDReg Knowledge Capsule – Episode [2]In this episode of the DDReg Knowledge Capsule, we dive into Digital Therapeutics (DTx), highlighting their role in transforming chronic disease management. It details how DTx, which are clinically validated, software-driven interventions, empower patients through personalised, data-driven care, evidence-based behaviour change, and 24/7 accessibility. 📍Stay i
Is Your Phone App a Medical Device?
📢 DDReg Knowledge Capsule – Episode [1]In this episode of the DDReg Knowledge Capsule, we dive into the evolving landscape of Software as a Medical Device (SaMD) — a transformative area in digital health that's reshaping patient care and healthcare delivery.Join us as we explore:🔹 What qualifies as SaMD under global regulatory frameworks🔹 Key regulatory guidelines from the FDA, EU MDR, and IMDRF🔹
