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Accelerate market entry with AI-powered dossier compilation and local representation, all for a flat annual fee. Starting at $2,000 USD per year for the first device (excludes government fees). Includes dossier submission, in-country representation, translation, modifications, distributor authorization, and post-market support.

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EU Harmonized Standards 2026 Update: Decision (EU) 2026/1231
EU Harmonized Standards 2026 Update: Decision (EU) 2026/1231
Regulatory Update

The European Commission has published Implementing Decision (EU) 2026/1231, updating the list of harmonized standards across several medical device areas. Manufacturers should review technical documentation, declarations, test documentation, and internal standards registers against the revised list.

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DJ Fang

DJ Fang writes on MedTech market intelligence, global regulatory strategy, and AI-enabled market access for Pure Global.

Co-Founder, COOUnited States / Americas7 articles
DJ Fang
DJ Fang
Co-Founder, COO
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About DJ Fang

DJ Fang writes on MedTech market intelligence, global regulatory strategy, and AI-enabled market access for Pure Global.

Topics
IVDAI DataCofeprisMdaRegulatory Compliance
Markets
BrazilChinaIndiaIndonesiaMalaysiaMexicoSingaporeThailand
Published by DJ Fang

Latest Articles

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Research ReportNovember 5, 2025
Indonesia's Medical Device and IVD Import Market

Indonesia's $3.28 Billion MedTech Import Market Reset: The IVD Bubble Is Over; The Surgical Boom Has Begun. The report emphasizes that the 2024 boom was not a simple recovery but a fundamental shift in market demand. The growth was overwhelmingly powered by specialties related to elective and high-acuity procedures, reflecting a move to clear surgical backlogs and a long-term government strategy to improve domestic hospital capabilities.

Research ReportSeptember 16, 2025
Thailand's Medical Device and IVD Import Market

Thailand's $3.29 Billion MedTech Import Market Undergoes Radical Shift as Post-Pandemic Demand for Aesthetics and Elder Care Surges, New Research Reveals. An analysis of historical data from 2021 to 2024 reveals an import-driven ecosystem with a total market value fluctuating between approximately $3.15 billion and $3.29 billion annually. This market is fundamentally sustained by two long-term drivers: a rapidly aging population and a thriving medical tourism sector, both of which are amplified by the government's strategic goal to establish the nation as a global "Medical Hub."

Research ReportSeptember 8, 2025
Brazil's Medical Device and IVD Import Market

Brazil's market for imported medical technology has demonstrated exceptional growth and a significant competitive realignment, establishing itself as a critical destination for global MedTech manufacturers. The total import market surged to USD $9.33 billion in 2024, an impressive 18.0% year-over-year increase, signaling a robust and accelerating demand for advanced healthcare solutions.

Research ReportAugust 13, 2025
[Research Report] Mexico's Medical Device and IVD Import Market

Mexico's medical device and in-vitro diagnostic (IVD) import market is a dynamic and rapidly expanding landscape, presenting both significant opportunities and complex challenges for global manufacturers. An analysis of historical import data from 2021 to 2024 reveals a market characterized by robust overall growth, shifting competitive dynamics among global trade partners, and transformative regulatory reforms. The total value of medical device and in-vitro diagnostic (IVD) imports to Mexico surged from $6.86 billion in 2021 to $11.40 billion in 2024, marking a 12.6% increase in the final year alone.

Research ReportJuly 28, 2025
[Research Report] Malaysia's Medical Device and IVD Market

The Malaysian medical device and in-vitro diagnostic (IVD) market presents a compelling, high-growth opportunity, projected to reach US$4.5 billion by 2028 with a robust compound annual growth rate (CAGR) of approximately 9%. This expansion is underpinned by strong economic fundamentals, a consistent increase in government healthcare spending—highlighted by a 10% budget increase for 2025—and a clear national strategy to modernize the healthcare sector.

Research ReportJuly 19, 2025
[Research Report] ASEAN MedTech Import Market

Exploring the profound opportunities and increasing complexity in the Association of South-East Asian Nations medical technology import market from 2021-2024. The ASEAN MedTech import market presents significant opportunities amid increasing complexity. Analysis of export data from 2021-2024 reveals robust growth drivers despite top-line volatility. While demographic and economic trends signal sustained demand, aggregate import value fluctuated from $19.16 billion in 2021 to $18.34 billion in 2022, $17.79 billion in 2023, before rebounding to $19.26 billion in 2024.

Blog ArticleOctober 28, 2024
Transla.ai: Simplifying Multi-Language Documentation for Global MedTech Companies

Multilingual documentation presents ongoing compliance and logistical hurdles for MedTech manufacturers. Transla.Ai is an industry-specific translation tool that can accelerate and streamline the translation process.

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