Regulatory

A complete guide to the regulatory pathway for digital therapeutics — including FDA clearance strategies (510(k), De Novo, PMA), EU MDR classification, Germany's DiGA reimbursement program, approved DTx products, clinical evidence requirements, and what's changing in 2026.

Everything you need to know about IEC 60601-1 compliance for medical electrical equipment — including basic safety, essential performance, collateral and particular standards, EMC requirements, FDA and EU MDR expectations, testing strategies, and what the upcoming 4th Edition means for your device.

Everything you need to know about registering medical devices in South Africa in 2026 — including SAHPRA requirements, establishment licensing, classification (Class A–D), ISO 13485 mandates, reliance pathways, Authorized Representative obligations, fees, and step-by-step registration instructions.

Everything you need to know about registering medical devices in Taiwan in 2026 — including TFDA requirements, the Medical Devices Act, classification (Class I–III), QSD certification, local agent obligations, UDI requirements, fees, timelines, and step-by-step registration instructions.

Everything you need to know about registering medical devices in Turkey in 2026 — including TITCK requirements, EU MDR/IVDR alignment, classification (Class I–III), UTS electronic registration, Authorized Representative obligations, fees, timeline, and step-by-step registration instructions.

Data-driven analysis of FDA 510(k) clearance rates, RTA hold rates, NSE decisions, and the most common reasons submissions fail — with actionable strategies to maximize your chances of first-cycle clearance in 2026.

Transparent benchmark of medical device regulatory consulting fees across 16 countries and regions — covering hourly rates by consultant tier, factors that drive cost, and how to budget for registration projects in the US, EU, Japan, Korea, China, India, Brazil, Saudi Arabia, and more.

How Nigeria procures medical devices through the NHIA insurance system, the new Medipool national GPO, Bureau of Public Procurement tendering, NAFDAC device registration, the BHCPF fund, PVAC local manufacturing initiative, and practical strategies for foreign suppliers entering Africa's largest medical device import market.

How South Korea procures and reimburses medical devices through the National Health Insurance Service (NHIS) — including MFDS approval, HIRA reimbursement listing, NECA health technology assessment, the new Immediate Market Entry pathway, pricing and payment mechanisms, and strategies for foreign manufacturers entering Korea's $7.5 billion medical device market.

How Thailand's government procures medical devices through the National Health Security Office (NHSO), e-Market and e-Bidding electronic procurement, the Universal Coverage Scheme, Thai FDA regulatory requirements, Innovation List procurement preferences, and practical strategies for foreign manufacturers entering Thailand's $2.2 billion medical device market.

Everything you need to know about the ASEAN Medical Device Directive (AMDD) and Common Submission Dossier Template (CSDT) in 2026 — including harmonized classification (Class A–D), CSDT sections and preparation, member state implementation status, regulatory reliance pathways, Singapore–Malaysia pilot, fees, timelines, and step-by-step guidance for multi-country ASEAN market entry.

Everything you need to know about Bureau of Indian Standards (BIS) certification for medical devices in India in 2026 — including which devices require BIS, applicable IS standards, ISI mark, registration schemes for Indian and foreign manufacturers, Manakonline portal, testing in BIS-recognized labs, relationship with CDSCO, costs, timelines, and step-by-step guidance.

Everything you need to know about using real-world evidence (RWE) and real-world data (RWD) for medical device regulatory submissions in 2026 — including the December 2025 FDA final guidance update, acceptable data sources (EHRs, registries, claims databases), relevance and reliability criteria, premarket and postmarket applications, de-identified data policy change, practical steps for incorporating RWE into your regulatory strategy, and comparison with traditional clinical evidence.

Everything you need to know about ANMAT medical device registration in Argentina — covering classification (Classes I–IV), Declaration of Conformity vs full review pathways, HELENA submission system, fees, timelines, authorized representative requirements, GMP compliance, and 2026 regulatory updates.

Everything you need to know about INVIMA medical device registration in Colombia — covering classification (Classes I–III), uncontrolled vs controlled pathways, Decree 4725 requirements, UDI-DI compliance, fees, timelines, legal representation, and post-market surveillance obligations for 2026.

A comprehensive comparison of medical device registration requirements across Latin America's six major markets — Brazil (ANVISA), Mexico (COFEPRIS), Colombia (INVIMA), Argentina (ANMAT), Chile (ISP), and Peru (DIGEMID) — covering classification, timelines, fees, pathways, and 2026 regulatory updates.

An independent, unbiased comparison of the top eQMS platforms for medical device companies in 2026 — covering Greenlight Guru, MasterControl, Qualio, QT9 QMS, ComplianceQuest, Arena QMS, and more. Includes pricing, features, ISO 13485 and QMSR readiness, and recommendations by company size.

Everything you need to know about marketing medical devices in France in 2026 — including EU MDR requirements, ANSM registration, EUDAMED deadlines, French-language labeling mandates, CNEDiMTS and CEPS reimbursement pathway, LPPR listing, clinical investigation procedures, materiovigilance obligations, and practical market entry guidance for Europe's second-largest medical device market.

Everything you need to know about marketing medical devices in Germany in 2026 — including EU MDR requirements, BfArM and PEI responsibilities, MPDG national law, German-language labeling mandates, DMIDS and EUDAMED registration, clinical investigation procedures, DiGA digital health pathway, and practical market entry guidance for Europe's largest medical device market.

Everything you need to know about registering medical devices in Israel in 2026 — including AMAR classification, declaration and fast-track routes, Israel Registration Holder (IRH) requirements, reference country approvals, SII certification, labeling in Hebrew, Arabic, and English, and step-by-step registration instructions.