News
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
Motherhood
Expectations about sleep affect postpartum sleep quality, study finds

Pregnant women’s expectations about postpartum sleep may predict sleep quality after birth, outweighing prior sleep and psychiatric history, a study suggests.
The findings suggest attitudes and beliefs about sleep during pregnancy could be a modifiable risk factor for postpartum sleep concerns.
They also indicate that, among women expecting the poorest sleep, higher postpartum anxiety may further worsen sleep quality.
Sammy Dhaliwal, lead author is clinical health psychologist and research fellow in the department of obstetrics and gynaecology at the Perelman School of Medicine at the University of Pennsylvania.
Dhaliwal said: “Most pregnant women in our sample anticipated poor postpartum sleep before it occurred, and it was striking that those expectations predicted worse sleep outcomes even after accounting for factors such as prior sleep disorders, psychiatric history, and number of previous births.
“This suggests that attitudes and beliefs about sleep during pregnancy may represent a modifiable target for early intervention before postpartum sleep problems emerge.”
Sleep disturbance affects an estimated 60 to 80 per cent of postpartum women and is linked to a higher risk of depression and anxiety.
Researchers said it is often regarded as an expected part of life after childbirth rather than a health issue that may be addressed earlier.
The study enrolled 432 pregnant women at about 24 weeks of gestation, meaning around 24 weeks into pregnancy.
Participants completed measures of their expectations about postpartum sleep, current sleep quality using the Pittsburgh Sleep Quality Index, and mood using validated depression and anxiety scales.
Assessments were repeated at six, 12 and 24 weeks postpartum.
A subset of 49 women also wore wrist actigraphy devices at six to eight weeks postpartum.
Actigraphy uses a wearable device, similar to a watch, to estimate sleep and wake patterns based on movement.
The results showed that 70 per cent of pregnant women, or 301 of 432 participants, expected poor sleep in the postpartum period.
Researchers found that predicted sleep disruption during pregnancy was a significant predictor of postpartum sleep concerns.
Among first-time pregnant women without prior health concerns, those who expected greater sleep disturbance had significantly more disrupted sleep after birth, measured by both actigraphy and self-report.
Among women who expected the worst sleep quality, higher postpartum anxiety significantly worsened both measured sleep and self-reported sleep, independent of anxiety levels during pregnancy.
Dhaliwal said the findings point to two possible areas for intervention: addressing sleep-related beliefs during pregnancy and treating postpartum anxiety.
Dhaliwal said: “Postpartum sleep disruption is often treated only after problems develop, but our findings suggest there may be an opportunity to intervene earlier during pregnancy.
“Addressing sleep-related beliefs and postpartum anxiety during prenatal and postpartum care may help improve sleep and emotional well-being in new mothers.”
Fertility
Weight loss jab shows early promise in improving PMOS fertility

A weight loss jab may improve fertility outcomes in women with PMOS, early findings from an ongoing clinical trial suggest.
The proof-of-concept analysis found that injectable semaglutide may offer reproductive benefits while also addressing obesity and metabolic dysfunction.
It is the first report to examine how injectable semaglutide may improve reproductive outcomes in women with PMOS while also addressing obesity and metabolic dysfunction.
The work forms part of the ongoing RESTORE clinical trial.
Melanie Cree, professor at CU Anschutz and first author of the report, said: “Women with PMOS frequently face a frustrating choice between treatments that target reproductive symptoms and those that address metabolic health.
“Our early findings suggest injectable semaglutide may have the potential to improve both, offering a more comprehensive approach to care.
“This medication is incredibly promising when someone responds with 10 per cent weight loss.”
The trial is examining whether semaglutide can restore ovulation and improve reproductive health in adolescents and adults with polyendocrine metabolic ovarian syndrome, known as PMOS.
PMOS, formerly known as polycystic ovary syndrome or PCOS, is a hormone and metabolic condition linked to irregular periods, raised testosterone levels, infertility risk, obesity and increased cardiometabolic disease.
Cardiometabolic disease refers to conditions linked to the heart and metabolism, such as heart disease, high blood pressure and type 2 diabetes.
Existing treatments, including metformin and hormonal contraceptives, often do not fully address reproductive and metabolic complications at the same time.
The analysis focused on participants aged 12 to 35 who lost at least 10 per cent of their body weight during treatment.
Researchers said reproductive improvements appeared earlier than expected, prompting them to report preliminary findings while the wider study continues.
Cree is also a paediatric endocrinologist at Children’s Hospital Colorado.
Endocrinologists are doctors who specialise in hormones and hormone-related conditions.
Cree said: “What makes this work particularly important is that it focuses specifically on women with PMOS receiving injectable semaglutide.
“Although GLP-1 medications have transformed obesity treatment, there remains a significant need for rigorous data examining how these therapies affect fertility and reproductive function in this population.”
The RESTORE study is evaluating semaglutide treatment in girls and women with PMOS and obesity.
Its broader aim is to determine whether weight loss and metabolic improvements can restore ovulation and improve reproductive outcomes.
Ovulation is the release of an egg from the ovary, a key part of the menstrual cycle and fertility.
The authors said the findings are from an early proof-of-concept analysis and that larger, longer-term studies will be needed to confirm whether the reproductive benefits last.
The findings suggest injectable semaglutide may become a treatment option for women with PMOS seeking improvements in both metabolic and reproductive health, if future studies confirm the results.
Events
Women’s Health Week Europe 2026 opens pitch applications for mainstage showcase at The Emirates Stadium

Women’s Health Week Europe 2026 has opened applications for its flagship start-up Pitches, giving women’s health innovators the chance to present on the mainstage at The Emirates Stadium in London on 7-8 October.
16 finalists will be selected across two categories: Medical Devices & Therapeutics and Consumer & Tech, with the shortlisted companies receiving the opportunity to pitch in front of 700+ investors, corporates, other innovators and strategic partners actively seeking solutions that can scale.
Two categories, one stage
The Medical Devices & Therapeutics category is open to companies working across medical devices, therapeutics and pharma innovation, regulated digital health, and deep-tech or science-led platforms.
The Consumer & Tech category covers consumer health and wellness brands, digital health platforms, wearables and connected data, employer and payor-led solutions, and commerce and marketplace businesses.
Any company treating a condition that affects women exclusively, differently, or disproportionately is eligible to apply.
Applications are completely free, so what do you have to lose?
Apply to pitch at WHW Europe 2026 now.
What’s in it for you?
Unmatched exposure
Present in front of 700+ investors, corporates, clinicians, and strategic partners actively seeking solutions that can scale.
With WHW Europe 2026 relocating to The Emirates Stadium and expanding to 700+ attendees across two stages, the 2026 edition represents the largest platform the series has offered to date.
A proven platform
The WHW Pitch Sessions have become one of the most commercially significant showcases in women’s health, with previous cohorts including companies that have gone on to raise investment and secure major strategic partnerships. 2024 alumni BoobyBiome, closed a £2.5M seed round in the year following their pitch at WHW Europe.
The Watchlist
All registered applicants will have the opportunity to be featured in The Watchlist, WHW Europe’s official directory of women’s health innovators to know, giving companies visibility beyond the pitch stage itself.
Applications close 28 August 2026.
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