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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 [email protected] or visit www.findbestivf.com
Women who do not use menopausal hormone therapy have a greater risk of developing osteopenia or osteoporosis, conditions that weaken bones and can lead to fractures, disability and loss of independence, new research suggests.
The retrospective cohort study included 387 postmenopausal women who underwent DXA scans between 2021 and 2025. A DXA scan is an imaging test used to measure bone mineral density.
Participants were classed as menopausal hormone therapy users, who made up 33 per cent of the group, or non-users, who made up 67 per cent.
Low bone mineral density was defined as osteopenia, where bones are weaker than normal, or osteoporosis, where bones become more fragile and more likely to break.
Women taking menopausal hormone therapy had about 69 per cent lower risk of low bone mineral density in the spine and hip compared with those not using it.
The association remained after researchers accounted for age, time since menopause, vitamin D levels, smoking and other health conditions.
Diego Espinoza-Peralta, vice president of the Mexican Society of Nutrition and Endocrinology and principal investigator at Investigación Médica Sonora, said: “For years, many women have avoided menopausal hormone therapy because of safety concerns and warning labels.
“This study revisits that narrative and shows that menopausal hormone therapy may have an important added benefit: protecting bone health. That shifts the conversation from ‘avoid if possible’ to ‘reconsider in the right patient.’
“In simple terms: menopausal hormone therapy appears to independently protect bones, not just by coincidence.”
The findings suggest hormone therapy could help some women find relief from menopausal symptoms while preventing bone loss or lowering fracture risk.
Espinoza-Peralta said: “Clinicians may begin to weigh its benefits more carefully, especially in women early after menopause, potentially improving long-term health and quality of life.”
Light exercise and less sitting may reduce pregnant women’s risk of serious blood pressure complications, according to a new study.
Researchers have proposed a daily activity and sleep guide that they say was linked to a nearly 30 per cent lower risk of hypertensive disorders of pregnancy.
The suggested pattern includes fewer than eight hours of sedentary time, at least seven hours of light physical activity, around 22 minutes of more intense activity and nearly nine hours of sleep.
The University of Iowa-led study examined the daily behaviours of 470 pregnant women across all stages of pregnancy.
Participants wore monitors that measured physical activity over 24-hour periods and recorded how long they spent asleep.
Hypertensive disorders of pregnancy include chronic high blood pressure, gestational hypertension and pre-eclampsia.
Gestational hypertension is high blood pressure that develops during pregnancy, while pre-eclampsia is a potentially serious condition involving high blood pressure and signs that organs may be affected.
Sedentary behaviour means being mostly inactive, such as sitting or lying down.
Light physical activity can include casual walking, moving around the home or standing.
Moderate to vigorous activity includes movement such as brisk walking, where breathing and heart rate increase.
Kara Whitaker, associate professor in the department of health, sport, and human physiology at Iowa and corresponding author of the study, said: “We are identifying the optimal composition of movement behaviours across the day associated with the lowest risk of developing HDP and the most improved health outcomes.
“This blueprint holds for each and every trimester of pregnancy.”
Study participants were enrolled at sites in Iowa City, Pittsburgh and Morgantown, West Virginia.
The women wore activity and sleep monitors for at least one week during each trimester of pregnancy.
Four in five participants were non-Hispanic white and nearly a quarter lived in rural areas.
The data showed a steep rise in risk among pregnant women who were sedentary for more than 10 hours a day.
Women who increased light physical activity to at least four hours a day reduced their risk of hypertensive disorders of pregnancy to 15 per cent from 30 per cent.
Whitaker said: “Just moving around more seems to have significant health benefits.
“And I think it also may be a more feasible target for women who are pregnant who are not exercising regularly.”
The researchers said they were surprised that longer durations of moderate to vigorous physical activity did not appear to provide additional benefit.
Sleep beyond a certain duration also did not appear to bring major further benefits.
Whitaker said: “Through this study, we are providing evidence that reducing sedentary behaviour and engaging in light physical activity are important, and maybe more important, when it comes to pregnancy and health.”
The findings may be relevant beyond pregnancy because clinical research has shown that women who develop hypertensive disorders of pregnancy are more than twice as likely to develop heart disease later in life.
Cardiovascular disease includes conditions affecting the heart and blood vessels, such as heart disease and stroke.
Whitaker said: “We know that cardiovascular disease is the number one killer of women, and if we can intervene in pregnancy and prevent women from developing a hypertensive disorder of pregnancy, we are putting them on a better trajectory, away from cardiovascular disease and toward more optimal cardiovascular health.”
The study was published online on June 10.
A second study, published online on May 27, looked more closely at the ratio and type of sedentary behaviour and light physical activity linked to a lower risk of hypertensive disorders of pregnancy.
Whitaker is a lead co-author on that study.
Co-authors in the June 10 study include Alex Crisp, Jaemyung Kim, Karina Smith, Donna Santillan, Mark Santillan and Bridget Zimmerman, from Iowa; Jacob Gallagher, from Iowa State University; Melissa Jones, from Oakland University in Michigan; Bethany Barone Gibbs, Katrina Wilhite, Alexis Thrower and Iqra Sheikh, from West Virginia University; and Sabera Rahman, Janet Catov, Christopher Kline and Maisa Feghali, from the University of Pittsburgh.
The National Institutes of Health, the University of Iowa Institute for Clinical and Translational Science, the University of Pittsburgh Clinical and Translational Science Institute and the West Virginia Clinical and Translational Science Institute funded the research.
We are excited to reveal the winners of the third annual Femtech World Awards.
The winners were announced at a virtual event this afternoon attended by shortlisted companies, along with sponsors and judges.
The event welcomed guests from the UK, Europe, Asia, Africa and North America.
Thank you to all 174 entries, as well as the sponsors for making the event possible.
See you in 2027!
Femtech World Awards 2026 Winners
Winner:
Shortlisted:
IVI RMA x Juno Genetics
Natural Cycles
Winner:
Highly commended:
U-Ploid
Shortlisted:
Hello Inside
Winner:
WISE HF, led by Prof. Mary Ryder
Highly commended:
Cardiac College for Women
Shortlisted:
Hyvelle Ferguson-Davis
CognitiveCare
Winner:
Highly commended:
Youterus
Shortlisted:
ŌURA
Winner:
Shortlisted:
LeanShield by ParrotPal Group
Perigen
Winner:
Shortlisted:
Body Moody
Looop
Winner:
Shortlisted:
Owning Your Menopause
Womeno
Winner:
Shortlisted:
The Blue Box
Celbrea
Winner:
Shortlisted:
HealCycle
Mor
Winner:
Shortlisted:
HRC Fertility
Mira
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