Regulatory

Register medical devices in Chile through ISP, including classification, GICONA submission, fees, timelines, documentation, and the 2026 decree expansion.

Guide to the European Commission MDR and IVDR simplification proposal, including software Rule 11, certificate validity, sandboxes, fees, timelines, and manufacturer impact.

How FTC enforcement is reshaping medtech M&A in 2025-2026, including Edwards/JenaValve, GTCR/Surmodics, HSR changes, and state mini-HSR laws.

Register medical devices in Peru through DIGEMID, covering risk classification, VUCE submission, documentation, holder duties, fees, timelines, and market access strategy.

Manage EU MDR Field Safety Corrective Actions, including FSCA triggers, 2/10/15-day reports, Field Safety Notices, EUDAMED, and FDA recall differences.

Guide to complaint handling for medical devices under FDA QMSR, ISO 13485, and EU MDR, covering intake, reportability, CAPA links, records, and audits.

Six-country ASEAN matrix covering distributor licenses, QMS and warehouse requirements, vigilance setup, and where FDA or NMPA test reports may reduce retesting.

How to classify hand sanitizer, mouthwash, personal lubricants, and data recorders as medical devices or non-devices across FDA, EU MDR, Brazil ANVISA, and Mexico COFEPRIS.

Learn how dual CE Mark and FDA 510(k)/PMA approval expands access across 25+ markets, speeds reliance registrations, and improves market-entry leverage.

Guide to FDA and EU regulation of drug-device combination products, covering OCP jurisdiction, RFDs, 21 CFR Part 4, EU MDR Article 117, CGMPs, and post-market duties.

See where CE marking supports device approvals across 25+ markets, including full reliance, abridged review, evidence acceptance, and remaining local steps.

Clarifies when Indonesian medical devices need BPJPH Halal certification, how AKD registration works, and why CDAKB obligations usually sit with local distributors.

What manufacturers should do after missing the 2024 MDR Notified Body deadlines, including legal status, withdrawal timing, fresh MDR applications, and sell-off rules.

Operational guide to transferring a Saudi SFDA MDMA authorized representative, covering process steps, 2026 fees, multi-AR rules, and escalation when the outgoing AR will not cooperate.

Guide to South Korea's Digital Medical Products Act, covering DMPA categories, MFDS classification, approval pathways, AI/ML requirements, cybersecurity, QMS, and labeling.

Guide to digital therapeutics regulation in 2026, covering FDA 510(k), De Novo, PMA, EU MDR classification, Germany's DiGA reimbursement route, clinical evidence, and global approvals.

Guide to IEC 60601-1 compliance for medical electrical equipment, covering basic safety, essential performance, collateral standards, EMC, FDA, EU MDR, testing, and Edition 4.

Guide to South Africa SAHPRA medical device registration in 2026, covering establishment licensing, Class A-D classification, ISO 13485, reliance pathways, fees, and AR duties.

Guide to Taiwan TFDA device registration in 2026, covering Medical Devices Act rules, Class I-III classification, QSD, local agents, UDI, fees, and timelines.

Turkey medical device registration guide for 2026, covering TITCK rules, EU MDR/IVDR alignment, UTS registration, representative duties, fees, and timelines.