The Elendi Files

An expert compliance blueprint for Kazakhstan and the Central Asia MedTech market for 2026. Meditor analyzes the indefinite validity of the National pathway before the 2027 deadline, Class 2A/2B registration costs, physical site audits, and CE mark advantages.

An expert breakdown of Singapore's HSA medical device regulations for 2026. Chee Wan from Asvien discusses the WHO Maturity Level 4 designation, the new SHARE digital portal, GDPMDS logistics, and cybersecurity for SaMD.

An expert blueprint of Bangladesh's medical device market for 2026. Saiful from ZIVA DRA details the DGDA's manual two-step registration pathway for Classes B, C, and D, reference country mandates, and the critical 'distributor hostage' risk.

An expert guide to navigating the US FDA medical device landscape for 2026. Srividya from Recordron discusses 510(k) vs. De Novo pathways, leveraging Q-submission meetings, lean QMS setups, and SaMD cybersecurity requirements.

An exhaustive blueprint of the 9-milestone EU MDR compliance journey for 2026. Maria from ETMP Consultancy breaks down technical file submissions, EUDAMED registration, and a case study on transitioning an FDA-cleared cardiology SaMD to Class IIb.

An expert overview of the UAE's medical device regulatory framework for 2026. Mai from Smart Medical Solutions outlines the EDE classification pathway, ADHICS cybersecurity for SaMD, and temperature-controlled logistics requirements.

An expert breakdown of EU MDR compliance and the upcoming EU AI Act for 2026. Eugenia from Instituto Pedro Nunes (IPN) discusses Notified Body timelines, the necessity of early Regulatory Affairs planning, and AI data diversity requirements.

An expert breakdown of Brazil's ANVISA medical device regulations for 2026, covering the Notification and Registro pathways, MDSAP audit optimization, fee structures based on local representatives, and LGPD data compliance.

An expert guide to China's NMPA medical device regulations for 2026. Peter from Ecomajor explains offline filing for Class 1, ERPS submissions for Class 2 and 3, fee structures, and how to mitigate distributor hostage risks.

An expert analysis of India's CDSCO medical device framework for 2026. Atul Sharma explains the Sugam portal, government fee structures, the 4-5 month FIFO timeline, and how to avoid the 'importer paradox'.

An expert breakdown of Saudi Arabia's SFDA medical device regulations for 2026, covering GHAD portal submissions, MDMA grouping, AR licensing costs, and using Saudi Arabia as a first-launch market.

Heena Thakkar, founder of VidyaRA, discusses the strategic shift in regulatory affairs between Western and Asian markets, the importance of tiered technical training, and why human experience remains irreplaceable in the age of AI.

An in-depth analysis of Turkey's medical device market entry under TİTCK regulations, highlighting the ÜTS tracking system, hybrid documentation demands, and the country's unique 'reverse' language requirements.

A deep dive into Kenya's medical product regulatory landscape for 2026. Dr. Atanga Ngare explains PPB classifications, the PRIMS online system, expedited 2-week approval pathways, and the complexities of KEBS import compliance.

Expert insights on Corrective and Preventive Action (CAPA), distinguishing between reactive fixes and proactive quality loops, and aligning with FDA and ISO 13485 standards.

An in-depth analysis of Malaysia's medical device market entry strategies for 2026, featuring expert insights on the MDA abridged pathway, CAB selection, and the critical intersection of device and drug regulations.

In this episode of The Elendi Files, Hussein Haidar, CEO of Product Registration Indonesia, breaks down the 'obligatory favoritism' of local content (TKDN), the risks of exclusive distributorship, and the evolving Halal requirements for medical devices.

Teddy, General Manager of ElendiLabs, speaks with Nayeem Syed from Infill Life about the complexities of entering the Indian medical product market, CDSCO regulations, the Sugam portal, and recent updates.

R. Yoloxóchitl Macias Ortega discusses the intricacies of COFEPRIS, the digitalization of Mexican health registrations, and strategies for medical device manufacturers to enter the Latin American market efficiently.

Host Teddy sits down with Andrew Gibson, Senior Managing Consultant at AKRA, to discuss the complexities, costs, timelines, and roadblocks of the European medical product regulatory landscape (EU MDR), with specific advice for startups.