Fertility
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
A hormone sensor being developed in Australia could help reduce fertility treatment costs and patient pain during IVF.
When preparing for egg collection or an embryo transfer, IVF patients rely on clinicians to closely monitor hormone levels to ensure the procedure is timed precisely when progesterone, oestradiol and luteinising hormone levels are optimal, giving the patient the best chance at conception.
Currently, blood tests are the primary method of measuring progesterone levels, requiring patients to undergo multiple blood draws at a laboratory during certain stages of their menstrual cycle.
However, this approach has several limitations.
For example, if testing falls on a weekend, when most labs are closed, IVF providers are forced to choose a less optimal testing time, potentially affecting treatment precision.
University of Melbourne alumni Edgar Charry and Muhammad Umer, whose partners have lived experience of infertility, created a reproductive health solution by developing a biosensor that can detect progesterone and oestradiol levels using fluid found in the skin, rather than in the blood.
Their startup company Symex Labs has partnered with the University of Melbourne to translate their research into a commercial product.
“Previous research shows nearly all hormones that exist in blood, are also present in interstitial fluid,” said Symex Labs co-founder Charry.
“Interstitial fluid is clear fluid just under the skin that sits between cells, delivering nutrients and carrying away waste.”
“Our biosensor will eventually be worn as a patch and will work by penetrating the skin using small microneedles to attract progesterone molecules in the patient’s interstitial fluid.
“These molecules will bind to the surface of the probe, generating electrical activity. The technology then translates the electrical activity to progesterone levels, ultimately informing the IVF clinical team if the patient is ready for embryo transfer.
“This data will be sent directly to the clinic’s monitoring system, allowing IVF nurses to review the results and advise the patient.”
Monash IVF research director associate professor Mark Green said that, for Monash IVF, the investment in Symex Labs aligns with the company’s focus on innovation and improving the patient journey.
“This technology will save patients time and money as they can conveniently wear the patch in the comfort of their own home, resulting in fewer visits to the clinic and fewer painful injections,” associate professor Green said.
“The biosensor would also be a gamechanger for women living in regional areas, who often have to travel long distances for blood draws.”
As the exact amount of progesterone in interstitial fluid is not well understood, Symex Labs is conducting a world-first clinical study at Monash IVF to establish baseline levels by benchmarking them against concentrations measured in blood samples.
Researchers say their hormone tracking technology also has wider clinical applications beyond the IVF sector.
“Our wearable hormone biosensor has strong potential well beyond fertility care, particularly in PCOS management, perimenopause and menopause symptom management, where continuous hormone insight can replace today’s indirect, symptom-based tracking,” said Symex Labs co-founder Muhammad Umer.
“By integrating directly with consumer health apps, the technology can enable personalised, data-driven management of chronic hormonal conditions and life-stage transitions that currently lack real-time biomarkers.
“For example, if a woman’s oestrogen is going up and down constantly, that’s often a sign that she is getting into that stage, so having access to this health information could help women implement lifestyle changes earlier.”
The research has received A$2.5m in funding from the federal government, the University of Melbourne’s Genesis fund, Monash IVF, RMIT and Breakthrough Victoria.
The first in-human pilot study is expected to get underway within the next 12 months, with commercialisation plans slated for early 2028.
Carea has introduced a digital support feature for people undergoing IVF, IUI and egg freezing, as clinics across the UK face rising demand and mounting concerns about fragmented care between appointments.
The London-based pregnancy and postnatal platform has added a “Trying to Conceive: IVF/IUI Mode” to its app, designed to support patients with the day-to-day realities of treatment that take place away from clinical settings.
This includes managing medication schedules, administering injections and keeping track of complex protocols at home.
Anastasia Shubareva-Epshtein, founder and chief executive of Carea, said the new feature was shaped partly by her own experience.
“It’s the tool I wish I’d had when I was going through IVF,” Shubareva-Epshtein said, describing the isolation and uncertainty that can accompany treatment.
More than 100,000 fertility treatment cycles were carried out in UK clinics last year, according to industry figures cited by Carea.
Specialists have warned that increasing volumes are contributing to a more transactional experience, with reduced continuity between consultations and limited opportunities for patients to raise questions outside scheduled appointments.
At the core of the new feature is a medication tracker, allowing users to input a personalised treatment plan, set reminders and log doses.
Step-by-step video guidance on medication preparation and self-injection is also included.
The mode offers IVF-focused educational content, such as expert-led articles and podcasts, alongside affirmations tailored to the emotional pressures of fertility treatment.
A visual progress indicator helps users see where they are in their cycle.
The feature was developed with input from women currently undergoing fertility treatment, including those managing multiple medications daily while balancing work and family life.
Although IVF is often portrayed as closely monitored, much of the practical workload falls to patients at home.
Daily injections, precise timing and last-minute protocol changes can add significant stress, particularly during the gaps between appointments.
The launch comes amid ongoing disparities in access to fertility services.
NHS-funded IVF accounts for around 27 per cent of treatments, according to public data referenced by Carea, and many local authorities fund only one cycle for eligible women under 40.
As a result, a substantial number of patients turn to private providers, where costs can run into several thousand pounds per cycle, excluding medication and additional procedures.
Dr Anil Gudi, founder of Fertility Plus and medical adviser at Carea, said many patients report a lack of continuity in care.
He said: “Unfortunately, IVF care in the UK is becoming increasingly impersonal.”
An open science initiative is accelerating work on non-hormonal contraceptives by targeting a sperm-specific enzyme linked to fertility.
The research focuses on developing a pill that works differently from hormonal contraception by temporarily disabling a protein found almost exclusively in sperm, rather than altering a woman’s hormonal cycle.
The target is an enzyme called phosphoglycerate kinase 2, or PGK2, which is critical for energy production and sperm movement.
Researchers believe that blocking PGK2 prevents sperm from generating the energy needed to swim and reach or fertilise an egg. Because the enzyme is largely confined to sperm cells, this approach could avoid many of the systemic side effects associated with hormonal contraceptives.
The work is led by the UNC Structural Genomics Consortium within the University of North Carolina’s Eshelman School of Pharmacy and is funded by the Gates Foundation as part of a broader effort to accelerate women’s health innovation.
Tim Willson, chief scientist for the consortium’s North Carolina programme, said: “Pregnancy is one of the major drivers of poverty in many of these countries.
“Giving women more control over when they conceive is a key area to make a real impact.
“What makes PGK2 so interesting is that it’s almost exclusively expressed in sperm cells. We suspect that if you can selectively inhibit this enzyme, the sperm can’t generate the energy they need to function.”
The consortium plays a central role in the Gates Foundation’s Contraceptive Drug Accelerator, a global network of academic laboratories working to identify and validate new drug targets for non-hormonal contraception.
Scientists from institutions in the US and India meet weekly to share data, compounds and findings.
In line with its open science approach, all aspects of the project are carried out openly, with no intellectual property restrictions.
“That’s where you really see open science at work,” Willson said.
“Every compound we make and every dataset we generate is shared immediately, which allows us to move incredibly fast.”
Since the project began in May 2025, the team has developed five highly selective probe compounds, an unusually rapid pace for early-stage drug discovery.
These compounds are now being distributed across the Gates Foundation’s Contraceptive Drug Accelerator network for testing in sperm function models.
“That specificity is the goal,” Willson said.
“We’re trying to shut down sperm function without interfering with the hormonal cycles that regulate women’s health.”
Researchers note that the work remains at an early stage and that any resulting contraceptive would still be several years away from clinical use.
“At the end of the day, the more we understand about human biology, the better drugs we can make,” Willson said.
“Open science removes barriers and lets the best ideas rise to the top.”
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