Entrepreneur
IVF innovation: What you need to know about global regulatory pathways in 2025
By Juan A. Jiménez, founder and CEO, FindDBest IVF
In the fast-moving world of fertility innovation, building a game-changing medical device or diagnostic is only half the journey.
The other half? Getting it approved — and into the hands of those who need it.
At FinDBest IVF, we work with IVF and ART (Assisted Reproductive Technology) device manufacturers around the world to help them navigate local regulations, identify distributors, and accelerate global expansion.
Over the past few months, we’ve been breaking down country-by-country regulatory updates in a series of accessible articles.
If you’ve missed them, don’t worry.
Here’s a quick, plain-language roundup of what’s new (and what’s changing) in the major regions IVF innovators are targeting in 2025 — from the United States and Europe to Brazil, China, the Middle East, and beyond.
United States – Getting Smarter with AI and Safer with UDI
The U.S. Food and Drug Administration (FDA) remains a global gold standard. But in 2025, two updates stand out:
- Quality System Alignment: The FDA has officially aligned its quality system with ISO 13485:2016 — a widely accepted international standard. This change means U.S. and European manufacturers now speak a more “common language” when it comes to quality documentation.
- AI Oversight & UDI: The FDA’s Digital Health division now requires AI-based software (like embryo scoring tools) to include performance monitoring and retraining protocols. Also, UDI (Unique Device Identifier) submission to the FDA’s database is mandatory for traceability. This affects any embryo kit, lab platform, or culture system sold in the U.S.
Tip: If you’re developing AI software for embryo selection or any connected device, plan early for post-market data collection and ongoing validation.
China – Stricter for AI, but More Open to Global Data
China’s regulator, the National Medical Products Administration (NMPA), has doubled down on innovation — and caution.
In 2025:
- AI-powered devices are increasingly treated as Class III — the highest-risk category — especially if they influence embryo transfer decisions.
- However, NMPA now accepts overseas clinical data in some cases (if the population data is relevant), reducing the need for local trials.
Also, connected IVF devices must now integrate with China’s UDI cloud system, and submit a cybersecurity risk report as part of the approval process.
Tip: Get local regulatory advice early — and expect your AI device to be subject to the most rigorous pathway.
European Union – CE Marking Under the MDR
Europe’s Medical Device Regulation (MDR) is in full effect, and IVF-related products like culture media, incubators, embryo transfer catheters, and AI software fall under tighter scrutiny than in the past.
What’s new:
- Classifications are stricter — many IVF consumables are now Class IIb or even Class III.
- UDI and post-market reporting are mandatory.
- Software (SaMD) requires usability testing, transparency around algorithms, and cybersecurity protection.
The CE Mark still unlocks the entire European market — but earning it now takes more time, documentation, and risk management.
Tip: Plan for at least 6–12 months to get through CE marking, depending on your device class.
ASEAN – Harmonized in Theory, Fragmented in Practice
Juan A. Jiménez
The Association of Southeast Asian Nations (ASEAN) introduced the AMDD (ASEAN Medical Device Directive) to harmonize device registration — but the reality is still very country-specific.
- Each country requires separate approval, despite using the same CSDT (Common Submission Dossier Template).
- Some markets (like Singapore and Malaysia) are faster and more tech-driven.
- Others (like Indonesia or Vietnam) still require local clinical data or language-specific labeling.
Tip: Use a single ASEAN-friendly dossier and localise as needed. Don’t assume one approval unlocks all 10 markets.
Latin America – Patchwork of Rules, Rising Demand
IVF demand is rising across Brazil, Mexico, Colombia, and Argentina, but regulations vary widely:
- Brazil (ANVISA): Class III/IV devices need a local GMP certificate and may face long timelines (9–18 months).
- Mexico: Recognizes CE/FDA under its “Equivalency Pathway,” which can fast-track approvals.
- Colombia and Argentina: Local sponsor/distributor is mandatory, and digital portals are evolving.
Also, Brazil and Mexico both require product documentation in Portuguese or Spanish, and some devices must comply with local technical standards.
Tip: A smart local partner who knows the IVF space is the fastest path to compliance.
Middle East – Local Sponsors + UDI = Mandatory
Key IVF markets in the Middle East — including Saudi Arabia, UAE, Egypt, Jordan, and Qatar — continue to grow. However, nearly all require:
- A local “Authorized Representative” (AR) or license holder
- UDI labeling (especially in Saudi Arabia under the Saudi-DI program)
- In some cases, bilingual labeling (Arabic + English)
Some authorities, like the UAE’s MOHAP, offer relatively quick review times (~45 working days), while others (e.g. Egypt or Bahrain) are tightening post-market requirements and traceability rules.
Tip: Don’t underestimate the value of an experienced local sponsor — they often control the registration certificate.
Australia & New Zealand – Gold Standard and Gateway
Australia’s Therapeutic Goods Administration (TGA) is globally respected. In 2025:
- UDI is mandatory starting July 2026 for higher-risk devices.
- AI software is regulated under SaMD (Software as a Medical Device) rules.
- Post-market vigilance requirements are increasing, with hospital-level reporting becoming mandatory in 2026.
New Zealand, meanwhile, repealed its planned regulatory overhaul. That means the WAND system — which only requires notification, not approval — continues for now.
Tip: Use Australia for your “gold standard” approval; use New Zealand for speed-to-market.
What This Means for You
Whether you’re developing AI-based software, culture media, cryopreservation devices, or genetic diagnostics — regulatory strategy is now core to your go-to-market plan.
The good news? There are clear pathways. The not-so-good news? They’re all a little different.
That’s where FinDBest IVF comes in.
We help medical device manufacturers:
- Find local regulatory-savvy distributors or license holders
- That understand country-specific timelines and dossier formats
- Stay ahead of new UDI, SaMD, and post-market changes
- Expand globally, faster — with fewer surprises
Want to connect with IVF-focused partners in any of these regions?
Email us at info@findbestivf.com or visit www.findbestivf.com
You have until Friday to nominate your femtech company of the year.
The award is one of 10 featuring at Femtech World’s third annual awards event, which attracts entries from across the UK, EU and Europe.
The Company of the Year Award is for companies that have demonstrated exceptional leadership in tackling women’s health needs through groundbreaking products, services or platforms that are shaping the future of global femtech.
If your company is driving innovation, impact and growth in this space, this award was made for you.
About the sponsor: Femovate
The category is backed by Femovate, the global femtech incubator using design to fuel innovation across every stage of a woman’s health journey, from proactive prevention through to personalised treatment.
Femovate has invested over US$2 million in design capital, working side-by-side with founding teams to bring market-ready solutions to life.
The startups it supports have collectively raised US$120 million, launched 30 products, and secured seven FDA clearances.
Why enter?
The Femtech World Awards are free to enter.
Winners and shortlisted companies receive extensive coverage across all Femtech World platforms.
Winners will also receive a trophy and the opportunity to be featured in an interview for the publication.
Find out more about the Femtech World Award and enter here by 4pm BST on Friday 17.
By Chaitra Vedullapalli, founder and president, Women in Cloud
Today’s leaders are carrying more than responsibilities.
They are carrying caregiving roles, financial pressures, legal complexities, and the quiet emotional weight of sustaining performance in unpredictable times.
And yet, most leadership forums still focus on productivity, growth, and scale, rarely addressing the human systems that enable sustained leadership.
At Women in Cloud, we believe the next generation of leadership will not be defined by endurance alone, but by discipline, preparation, and self-respect.
That is why we are proud to announce the #WICxWellness Summit 2026: The Disciplined Advantage.
This is a wellness summit focused on leadership preparedness.
Why This Summit Matters Now
Across our global community, a clear pattern has emerged.
- More professionals and executives are quietly navigating:
- Life-threatening health crises, personally or within their families
- Financial stress caused by medical, caregiving, or business shocks
- Legal and healthcare decisions with long-term consequences
- Career interruptions due to caregiving responsibilities
- Chronic exhaustion, grief, and emotional isolation
These experiences are widespread, yet rarely discussed in executive settings.
#WICxWellness 2026 brings these realities into the open with compassion, clarity, and practical guidance, so leaders can prepare, adapt, and continue forward without breaking.
This is wellness as a leadership discipline.
What We Will Explore
This year’s summit is designed to provide grounded, immediately applicable insights for founders, executives, and senior leaders.
Executive Function Under Chronic Stress
Keynote with Jennifer Brown
Focus Areas:
- Understand how chronic stress alters judgment, focus, and emotional regulation
- Identify early warning signs of cognitive overload in leadership roles
- Adaptability as a Cognitive Anchor: Navigating rapid change without compromising decision-making.
- Resilience Through Connection: Building human-centric teams to mitigate the stress of uncertainty.
- Navigating Change with Emotional Intelligence: Regulating stress responses to maintain clarity and empathy.
- Systemic Agility in High-Pressure Environments: Creating foundations of psychological safety that protect organizational function
Labs That Matter (And What to Do With Them)
Fireside Chat with Chelsey Galipeau and Chaitra Vedullapalli
Focus Areas:
- Which health tests are worth the time and investment
- Interpreting results without panic
- Preventive strategies for executive longevity
- Avoiding unnecessary medical spending
Caretaking Without Collapse
Panel With Karen Fassio, Anca Platon Trifan, Scilla Andreen, Clara Schroeder, Sheena Yap Chan
Focus Areas:
- Managing family and professional demands without burnout
- Setting humane boundaries
- Building sustainable support systems
- Ending silent sacrifice in leadership
Food as a Stability System (Not a Diet)
Fireside Chat with Nancy Watt and Meagan T. Copelin
Focus Areas:
- Nutrition for sustained energy and clarity
- Blood sugar and decision-making
- Realistic eating during travel and stress
- Food as operational resilience
Autoimmunity, Hormones & Cardiac Risk in Real Life
Fireside Chat with Dr. Linda Bing
Focus Areas:
- Managing invisible health risks
- Hormonal transitions and stamina
- Flare prevention at work
- Energy mapping for leadership performance
A Different Kind of Leadership Conversation
At Women in Cloud, we have learned something fundamental:
Performance is visible. Discipline is invisible.
Yet discipline determines whether leaders can serve, build, and lead over decades, not just quarters.
The Disciplined Advantage is about building that resilience intentionally.
Through science, lived experience, and practical frameworks, this summit equips leaders to:
- Anticipate strain instead of reacting to a crisis Design sustainable work rhythms
- Protect cognitive and emotional capital
- Lead from grounded strength
This is leadership infrastructure for the next decade.
Join Us
If you are a founder, executive, technologist, or senior professional navigating complexity and determined to lead well without sacrificing your health, clarity, or longevity, this summit is for you.
The #WICxWellness Summit 2026 is where performance meets preservation. Where ambition meets sustainability. Where leadership becomes truly durable.
We look forward to welcoming you. The Disciplined Advantage begins here.
Secure your spot: https://www.eventbrite.com/e/wicxwellness-summit-2026-tickets-1981616382945?aff=oddtdtcreator
Femtech World is continuing the search for a company to be crowned Startup of the Year.
The award is one of 10 to feature at the third annual Femtech World Awards.
The Startup of the Year Award celebrates an early-stage company making a bold impact in women’s health through innovation, vision and execution.
The winning startup will have demonstrated strong potential to transform care, accessibility, or awareness in women’s health with a scalable solution.
Consideration will be given to innovation, market traction, inclusivity, impact and the ability to address unmet needs.
The award is sponsored by Future Fertility.
The company is transforming fertility care with AI-powered solutions that close critical information gaps along the IVF journey.
Its clinically validated, non-invasive tools analyse oocyte images to predict each egg’s reproductive potential, supporting decision-making across key pathways: VIOLET™ for egg freezing, MAGENTA™ for IVF-ICSI, and ROSE™ for donor programmes and egg banks.
These reports deliver personalised insights into egg quality and ploidy potential, empowering patients and clinicians to make more informed decisions regarding next steps.
Today, Future Fertility’s technology is used in more than 300 clinics across 35+ countries.
Developed with the world’s largest oocyte image dataset linked to reproductive outcomes, Future Fertility’s AI models generate quality scores that not only guide treatment planning and manage expectations, but also serve as objective, actionable KPIs for labs—driving improved outcomes and transparency in fertility care worldwide.
The awards are free to enter, with winners receiving a trophy and an interview with Femtech World.
Find out more about the awards and enter for free here.
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