What Certifications Should My IVF Clinic Have?
If you are comparing IVF clinics, you have probably noticed that some clinics proudly display certificates from national or international bodies as a sign of quality. But what do these certifications mean, and which ones really matter?
Your clinic may hold four different kinds of credentials, and they are not interchangeable: a government license, an accreditation specific to assisted reproductive technology (ART), a hospital-wide accreditation, and conformance certificates such as the ISO standards. Let’s look more closely at each one.
First is a government license to operate as an IVF clinic and laboratory. In most countries this is mandatory, and you can usually check on a government website whether your clinic holds one. If a clinic is operating without a license that it is required to hold, this is a major red flag. But surprisingly, a few countries have no IVF-specific license at all. Japan has no national licensing system for fertility clinics, Malaysia licenses them as ordinary private hospitals or clinics with no fertility category, and the Philippines has no assisted reproduction law at all. In those countries, “licensed” means only licensed as a medical facility. In countries with mandatory licensing, the process varies a great deal. Taiwan inspects a clinic before it will issue a permit, and publishes the expiry date of every clinic’s permit. Hong Kong carries out unannounced inspections. Elsewhere the process may not be as robust.
Second is an ART-specific accreditation. These are usually voluntary. Examples include the Reproductive Technology Accreditation Committee (RTAC) of the Fertility Society of Australia and New Zealand (FSANZ); the College of American Pathologists (CAP) Reproductive Laboratory Accreditation Program; the European Society of Human Reproduction and Embryology (ESHRE) center accreditation, which is open to European clinics only; and the Japanese Institution for Standardizing Assisted Reproductive Technology (JISART). After mandatory licenses, this category matters most, because these are the only accreditations that assess the IVF lab (the room where your eggs are fertilized and your embryos are grown). The ones you are most likely to encounter in Asia are RTAC and CAP, and we’ll come back to both later.
Third is hospital or general accreditation, which is also voluntary. Examples include Joint Commission International (JCI) and national hospital schemes such as the Malaysian Society for Quality in Health (MSQH) or Thailand’s Healthcare Accreditation Institute, whose program is known as HA. These assess the institution, not the fertility unit inside it. It is good to know that a hospital meets these standards, but it tells you nothing about the quality of its IVF lab. So treat it as a signal of hospital quality, not as a criterion for judging the IVF lab.
Finally, ISO certificates. These voluntary certificates show that a facility follows a documented process or was built to a particular specification. ISO 9001, for example, confirms that a clinic reliably does what its own procedures say it does. This makes it a useful administrative discipline but doesn’t have any clinical meaning. Some clinics advertise ISO 15189, which is a genuine laboratory accreditation, but it is granted only for a certain list of tests. In most countries, embryology is not on that list. So, when a fertility clinic advertises ISO 15189, it almost always refers to its genetics or sperm-testing work rather than the IVF lab. If you want to be thorough, ask the clinic which tests the accreditation covers. Even so, these certificates should not be a make-or-break criterion.
Most clinics advertise their accreditations and certifications. In Asia, the three you are most likely to see are RTAC, CAP and JCI, so let’s look at each in a little more detail.
RTAC is an awarding body and a standing committee of the Fertility Society of Australia and New Zealand (FSANZ). FSANZ is a professional society, not a government body. There are actually two separate codes: a domestic Australia/NZ Code, and an International Code of Practice licensed for use by certifying bodies outside Australia and New Zealand. Asian clinics are certified against the International Code. Currently, clinics in Thailand, Malaysia and Vietnam advertise RTAC accreditation.
In Australia and New Zealand, RTAC accreditation is effectively mandatory: it is what makes patients eligible for rebates under Australia’s public health system, and it is written into several state ART laws. Clinics there also report their results into a shared national database called ANZARD, and a clinic whose results fall below the national benchmark must investigate why and, if the problem persists, work to an improvement plan under closer supervision.
Is the RTAC process the same in Asia? Partly. The audit structure is similar, with annual visits and the full set of criteria covered over three years. But Asian clinics are certified against the International Code, and they do not report into ANZARD, the national results database. ANZARD is a large part of what gives RTAC its teeth at home, and it simply does not apply overseas. So, an RTAC certificate in Asia tells you a clinic passed an audit of its systems; it does not tell you how one clinic compares to another.
Next let’s look at the CAP Reproductive Laboratory Accreditation Program (RLAP). This is the most IVF-specific laboratory accreditation in existence, and it is available internationally. The awarding body is the College of American Pathologists, a US professional society. It covers embryology, andrology, reproductive hormone testing, the freezing and storage of eggs, sperm and embryos, and genetic testing of embryos – in short, the major things you’ll want your IVF lab to do. Technically it is voluntary, but in the US, it is effectively compulsory: membership in the Society for Assisted Reproductive Technology (SART), the main professional body for fertility clinics there, requires the embryology lab to be accredited by CAP or The Joint Commission every two years. CAP also sets qualification requirements for the laboratory director and lab staff, though not for the doctors. Inspections take place every two years and are carried out by working embryologists from other labs. The bottom line: this is a rigorous accreditation, and it is meaningful if your clinic holds it. CAP publishes a searchable directory of accredited labs, and searching it suggests that in Asia, only clinics in Taiwan have pursued it so far.
Finally, let’s turn to Joint Commission International, the international division of The Joint Commission, a US private non-profit. JCI accredits only organizations outside the United States; a US clinic’s “Joint Commission accreditation” is the separate domestic program. Many hospitals across Asia hold JCI accreditation. It’s a good sign if your hospital is one of them, but the general hospital accreditation contains nothing specific to IVF. JCI does, however, run a separate accreditation for laboratories, and that one covers the IVF lab. It checks, among other things, that a second person verifies the identity of eggs, sperm and embryos at each critical step — what labs call witnessing — that every sample can be traced, and that everything in frozen storage is properly tracked. JCI also publishes an online directory, so this is another one you can check for yourself.
So what should you do with all this? Three suggestions:
Check for yourself that your clinic holds every mandatory government license, using the online register published by the regulator or licensing body.
Check voluntary accreditations on the accrediting body’s website where one exists (CAP and JCI both publish directories), or by asking the clinic for a copy of its certificate where one does not (RTAC has no public register).
Ask which specific program an accreditation refers to, and whether it covers the IVF lab or only the hospital (particularly for JCI or ISOs).
If a clinic holds none of the voluntary accreditations, don’t rule it out on that basis alone. Plenty of good clinics have never sought them, particularly in countries where nobody else has either. Treat these as one signal among several, not as a scorecard.
We hope this helps to demystify licenses, accreditations, and certifications in Asia, and which ones matter when you choose an IVF clinic. At Building Asian Families, we exist to provide independent information on egg donation and surrogacy for Asian families so that you can make the best decision for your family. We want to give you the information to make decisions confidently and quickly, so that you can move on to building the family of your dreams.
