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IVF innovation: What you need to know about global regulatory pathways in 2025

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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:

  1. 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.
  2. 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

Menopause

Menopause hormone therapy may improve cardiovascular health outcomes, study suggests

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Hormone therapy started in peri- or early post-menopause was linked to a 22 per cent lower risk of cardiovascular events in women with vasomotor symptoms in a recent study.

The findings came from an observational analysis of 20 years of health data and do not show that hormone therapy caused the reduction in cardiovascular risk.

The association was strongest among Black women and women who started treatment within 10 years of menopause onset, although researchers cautioned that the findings should not guide clinical practice.

The study is the first of its kind in the US to assess the risk of future cardiovascular events among women with vasomotor symptoms who use hormone therapy during peri- and early postmenopause.

Samar R. El Khoudary, professor and chair of the Department of Epidemiology at the VCU School of Public Health and one of the study’s senior researchers, said: “The menopause transition represents a critical window for understanding how hormone therapy may relate to cardiovascular disease risk. Our findings suggest that timing of initiation may influence cardiovascular outcomes.”

The researchers stressed that the findings do not support using hormone therapy to prevent cardiovascular disease.

Potential benefits must also be weighed against risks, including the increased breast cancer risk observed with longer-term use.

The study was not a randomised controlled trial, the gold-standard method for testing biomedical treatments.

Rebecca C. Thurston, associate dean for Women’s Health Research at the University of Pittsburgh School of Medicine and one of the study’s senior researchers, said: “These findings point to women with vasomotor symptoms as those who may show cardiovascular benefit from hormone therapy initiated during the perimenopause and postmenopausal years.

“However, conclusions should be tempered by the observational nature of the study, and findings should not guide clinical practice.”

Vasomotor symptoms, meaning hot flushes and night sweats, affect up to 80 per cent of women during the menopause transition and last for an average of seven to ten years.

Their frequency and severity build through perimenopause and typically peak in early postmenopause.

Hormone therapy replaces oestrogen and progesterone that women’s bodies stop producing after menopause and is currently the most effective treatment for these symptoms.

Clinical trials led by the Women’s Health Initiative in the early 2000s raised concerns about hormone therapy’s impact on heart disease, stroke, breast cancer and other risks, leading to years of reluctance among patients and providers to use the treatment.

El Khoudary said: “Hot flashes and night sweats have a significant impact on a woman’s quality of life and ability to work productively.

“While hormone therapy is an effective treatment for these symptoms, questions have remained about its cardiovascular effects, particularly the importance of when treatment is initiated during the menopause transition.”

More recent research suggests the effects of hormone therapy on the heart and vascular system may vary by age and treatment timing, with women younger than 60 who start treatment closer to menopause onset having different levels of risk.

In 2026, the US Food and Drug Administration removed “black box” warnings from hormone therapy products, reflecting evolving evidence on the benefits and risks of treatment.

Researchers from Virginia Commonwealth University and the University of Pittsburgh analysed data from more than 2,700 women taking part in the Study of Women’s Health Across the Nation (SWAN).

The women reported vasomotor symptoms and had not previously experienced cardiovascular events.

Clinical data collected between 1997 and 2017 were used to examine whether women who started hormone therapy for vasomotor symptoms were more or less likely to experience stroke, congestive heart failure, heart attack or revascularisation procedures than women who did not start treatment.

El Khoudary said: “By using data from the SWAN study, we essentially were able to emulate a series of hypothetical clinical trials to gain a deeper understanding into how hormone therapy taken to mitigate vasomotor symptoms during peri- and early postmenopause influences cardiovascular risk over time.

“It allowed us to examine clinically meaningful cardiovascular disease events over long-term follow-up in a population and treatment window that has been challenging to study prospectively.”

Starting hormone therapy during peri- or early postmenopause was associated with an estimated 22 per cent lower risk of cardiovascular disease events.

Women who began hormone therapy within 10 years of menopause onset had an estimated 27 per cent lower risk compared with women who did not start treatment.

Among Black women, starting therapy during peri- or early postmenopause was associated with an estimated 49 per cent lower risk of cardiovascular disease events.

No clear reduction was seen among women who started therapy more than 10 years after menopause onset or among White women and other racial and ethnic groups.

El Khoudary said: “The differences in cardiovascular outcomes by race and ethnicity are notable, particularly because Black women are more likely to experience severe vasomotor symptoms.

“These findings highlight the need to better understand how hormone therapy timing may influence cardiovascular outcomes across diverse populations.”

It remains unclear why cardiovascular risk differed according to when hormone therapy was started, although researchers believe differences in blood vessel health with age may play a role.

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Hormonal health

Study links small bowel microbiome differences to women’s health

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Small bowel microbiome differences between women and men may help explain why some conditions are more common in women, a study suggests.

The small bowel microbiome is the community of microorganisms living in this part of the digestive tract, where they play vital roles in immune function, metabolism and hormonal regulation.

Researchers found differences between women and men in the composition and organisation of these microbial communities. One bacterial community containing Granulicatella was found only in women.

The study was conducted by investigators at Cedars-Sinai Health Sciences University.

Ruchi Mathur, director of clinical research and clinical operations for the Medically Associated Science and Technology (MAST) Program at Cedars-Sinai and corresponding author of the study, said: “One intriguing finding was a bacterial community containing Granulicatella, which we found only in women.

“Bacteria in this community appear at increased levels in women with polyendocrine metabolic ovarian syndrome, formerly known as polycystic ovary syndrome.”

The researchers also identified differences between women and men in how microbes in the small bowel produce fructans, complex carbohydrates known to trigger digestive symptoms in irritable bowel syndrome (IBS).

IBS is far more common in women than men.

Mathur, who is also a professor of medicine, said: “Our findings show that biological sex is a critical variable in the small bowel microbiome.

“We must consider it as we move toward more personalised approaches to understanding and treating disease.”

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Menopause

Cancer drug could tackle osteoporosis menopause weight gain

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An experimental cancer drug reduced bone loss and body fat in mice modelling post-menopausal changes, early research suggests.

The compound, CADD522, appeared to strengthen bones and help the animals stay leaner after surgery designed to mimic hormonal changes seen after menopause.

The treatment remains at an early experimental stage and has so far only been tested in animals.

The study, led by the University of East Anglia, investigated CADD522, which was originally developed to block a protein involved in the growth and spread of several cancers.

Mice treated with the compound for eight weeks showed significant improvements in bone health. Scans found increased bone volume and better preservation of the honeycomb-like structures inside bones that are crucial for strength and resilience.

Blood tests suggested the treatment stimulated new bone growth without interfering with the body’s normal process of breaking down and rebuilding bone.

Dr Darrell Green, lead researcher from UEA’s Norwich Medical School, said: “Osteoporosis affects around one in three women over the age of 50, leaving sufferers vulnerable to painful fractures that can seriously impact quality of life.

“Current treatments exist, but many are plagued by side effects, safety concerns or inconvenient dosing schedules that make long-term use difficult.”

The researchers also found that mice receiving CADD522 weighed less than untreated mice despite eating the same amount of food.

They had less body fat and fewer fat deposits in their bone marrow, a process commonly seen after menopause and linked to declining bone health.

The team also examined brain tissue and found that the drug appeared to reverse several menopause-related changes in fatty acids.

Levels of omega-3 fats including DHA remained largely intact, while several other lipid abnormalities shifted back towards healthier patterns.

Green said: “We didn’t directly test for memory or thinking ability, but our work raises questions about whether this drug could one day help address wider menopause-related health problems.”

Safety experiments in mice, rats and dogs found that CADD522 could be taken orally and was well tolerated.

The compound also appeared to be metabolised more slowly in human tissue than in rodents, potentially improving its performance in people.

“This is still in the early stages and has so far only been tested in animals but we hope that the benefits will translate to humans to ultimately reduce fracture rates,” added Green.

The research was led by UEA in collaboration with the University of Maryland, the Scintillon Research Institute in San Diego and the University of Stirling.

Safety testing was funded by The Sir William Coxen Trust as part of the development of CADD522 as a childhood cancer treatment.

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