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
Wellness
AstraZeneca drug approved for breast cancer in EU

AstraZeneca’s breast cancer drug Etcamah has been approved in the EU as part of a combination treatment for advanced disease.
The European Commission acted on a positive opinion from the Committee for Medicinal Products for Human Use, the Cambridge, England-based drug maker said.
The decision followed positive results from the Serena-6 phase III trial, which showed a 56 per cent reduction in the risk of disease progression in advanced oestrogen receptor-positive breast cancer.
A phase III trial is a large, late-stage study used to assess a treatment’s safety and effectiveness before wider regulatory approval.
Oestrogen receptor-positive breast cancer is a form of the disease that can grow in response to the hormone oestrogen.
Etcamah, whose generic name is camizestrant, was tested in combination with a cyclin-dependent kinase 4/6 inhibitor.
Known as CDK4/6 inhibitors, these medicines block proteins that help cancer cells grow and divide.
AstraZeneca said the Etcamah combination has also been approved in Japan, the UAE and Saudi Arabia based on the Serena-6 trial results.
The company said breast cancer remains the leading cause of cancer death among women in Europe, with more than 140,000 deaths and more than 540,000 patients diagnosed in 2024.
AstraZeneca shares were down 0.6 per cent at 12,628 pence in London on Thursday.
Insight
From Hologic to Ark Surgical: Why Joseph LaBruzzo is betting on the future of women’s surgical innovation

After more than two decades leading organisations at some of the world’s most respected medical device companies, including Hologic, SenoRx Breast Care, and BTL Industries, Joseph B. LaBruzzo is embarking on a new chapter as President & CEO of U.S. Operations and Board Member at Ark Surgical.
We sat down with Joseph to discuss what drew him to Ark Surgical, why he believes women’s surgical innovation is entering a transformative era, and what it takes to bring meaningful technologies from concept to standard of care.
You have held leadership positions at some of the biggest names in MedTech. What attracted you to Ark Surgical?
Throughout my career, I’ve been fortunate to work with organisations that developed technologies capable of changing the standard of care.
What attracted me to Ark Surgical is the opportunity to help address a meaningful unmet need in gynecologic surgery with an innovation that has the potential to improve patient outcomes while preserving the benefits of minimally invasive surgery.
Opportunities like that don’t come along very often.
FemTech World recently highlighted that many women remain unaware of gynecologic cancers and that unexpected diagnoses continue to have a profound impact on patients and families.
How has your own experience shaped the way you think about innovation in women’s health?
Earlier in my career, I witnessed many women receive life-changing cancer diagnoses.
Those experiences stayed with me and reinforced my belief that if there’s an opportunity to reduce risk through better innovation, it’s one worth pursuing.
That’s one of the reasons I was drawn to Ark Surgical.
The vast majority of minimally invasive gynecologic procedures are performed for conditions believed to be benign. Unfortunately, in rare cases, pathology later reveals an unexpected malignancy.
LapBox was designed with a proprietary dual-wall tissue containment system to help facilitate contained specimen retrieval and minimise the risk of tissue spillage during laparoscopic procedures.
I believe innovations like this can help surgeons manage the unexpected while preserving the many benefits of minimally invasive surgery for women.
Women’s health has gained significant momentum in recent years, yet surgical innovation often receives less attention than diagnostics or therapeutics. Why do you think that is?
Women’s health has historically been underfunded and underserved across many areas of medicine, and surgery is no exception.
While we’ve seen tremendous advances in diagnostics and pharmaceuticals, there are still important opportunities to improve the surgical experience for both physicians and patients.
Innovation that enhances safety, efficiency, and outcomes has the potential to make a lasting impact.
What excites you most about LapBox?
LapBox addresses a very real challenge that gynecologic surgeons face during minimally invasive procedures.
It was thoughtfully designed to integrate seamlessly into the surgical workflow while providing an added layer of confidence when tissue retrieval is required.
I believe technologies that solve real clinical challenges in a practical way have the greatest potential to become part of the standard of care.
What do you see as the biggest unmet needs in minimally invasive gynecologic surgery today?
The future of surgery isn’t simply about making procedures less invasive. It’s about making them smarter and safer.
Surgeons need technologies that integrate seamlessly into their workflow while helping them navigate increasingly complex clinical situations.
Every advancement that helps reduce risk while preserving the benefits of minimally invasive surgery has the potential to improve outcomes for both physicians and patients.
That’s where I believe the greatest opportunities for innovation exist.
As you take on this new role, what are your priorities over the next 12 months?
Our focus over the next 12 months is to build a strong foundation for growth. That means expanding physician partnerships, driving early clinical adoption, growing our team, and ensuring that more surgeons have access to technologies like LapBox.
At the same time, we’re focused on building strategic relationships with investors, healthcare systems, and industry partners that support our long-term vision.
What advice would you give entrepreneurs building the next generation of women’s health companies?
Start with a real clinical problem and never lose sight of the patient.
Great technology alone isn’t enough. You also need strong clinical evidence, physician advocates, and a clear market strategy. The companies that succeed are the ones that bring all of those pieces together while remaining focused on improving patient care.
About Joseph B. LaBruzzo
As President & CEO of U.S. Operations and Board Member, Joseph LaBruzzo is leading Ark Surgical’s U.S. growth strategy, physician partnerships, strategic investment initiatives, and organisational expansion, supporting the company’s mission to advance safer minimally invasive gynecologic surgery through innovative technologies.
Pregnancy
Pregnancy complications may increase risk for artery disease, study finds

Pregnancy complications may increase women’s risk of peripheral artery disease later in life, new research suggests.
The study analysed data from more than two million women in Sweden who gave birth to single babies between 1973 and 2015.
Led by Casey Crump, the research examined the long-term risk of peripheral artery disease among women who experienced preterm delivery, pre-eclampsia, gestational diabetes or other adverse pregnancy outcomes.
Crump, professor in the department of family and community medicine at McGovern Medical School at UTHealth Houston, said: “Our prior work has already shown that adverse pregnancy outcomes are associated with long-term risks of heart disease, stroke, and heart failure.
“This study builds on that work by showing that these women have an increased risk of peripheral artery disease, an important but understudied cardiovascular condition.”
Peripheral artery disease is often a precursor to long-term cardiovascular complications, including stroke, ischaemic heart disease and premature death.
The condition affects millions of people worldwide and occurs when narrowed arteries reduce blood flow, most commonly to the legs and feet.
Ischaemic heart disease occurs when the heart does not receive enough blood and oxygen, usually because the arteries have narrowed.
Symptoms of peripheral artery disease can include leg pain, cramps while walking, numbness, cold feet and sores on the feet or legs that are slow to heal.
Crump said women who experience pregnancy complications have an important opportunity after giving birth to make plans with their primary care doctor to monitor long-term risks.
Women who have experienced complicated pregnancies should speak with their doctor about possible future cardiovascular health risks.
Checks for blood pressure, diabetes and cholesterol are important.
While the period after childbirth is an important time for women to monitor their health, Crump said it is never too late to lower the risk of peripheral artery disease.
He said: “Women with a history of adverse pregnancy outcomes who seem to be doing well may still have a higher risk that can emerge later in life.”
Crump also suggested preventive steps such as avoiding smoking, maintaining a healthy weight and following a healthy lifestyle.
He stressed the importance of long-term follow-up care and conversations with healthcare providers to help protect cardiovascular health later in life.
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