PGT-A Kit Listed as Class III Medical Device Under China's Mandatory Industry Standards for the First Time

On July 9, the General Office of the National Medical Products Administration issued a “Notice on Further StrengtheningMandatory Industry Standards for Medical DevicesNotice on Matters Concerning the Administration of... (hereinafter referred to as the “Notice”), which requires relevant entities to strengthen their understanding of industry standards, effectively promote mandatory industry standards for medical devices, and ensure their implementation. Among them,PGT-A kits will also be included for the first time in the national mandatory industry standards for medical devices as Class III medical devices on August 1.。

Mandatory industry standards for medical devices serve as the gold standard to be followed in the absence of mandatory national standards for such products. According to Article 6 of the General Provisions of the Regulations on the Supervision and Administration of Medical Devices, promulgated by the State Council in 2014: Medical device products shall comply with mandatory national standards for medical devices;Where no mandatory national standards exist, compliance with the mandatory industry standards for medical devices is required.. Fully affirmedMandatory Industry Standards for Medical Deviceslegal status, and requires all relevant entities to effectively uphold the authority of mandatory industry standards.

The “Notice” points out that mandatory industry standards for medical devices areUniform Technical Requirements for the Research and Development, Production, Operation, Use, and Supervisory Administration of Medical Devices, are standards designed to safeguard human health and life safety, covering product safety and essential performance requirements. Entities involved in the development, manufacturing, distribution, and use of medical devices shall actively participate in training and proactively conduct internal training to enhance their understanding of these standards and ensure their effective implementation.

In recent years, the National Medical Products Administration (NMPA) has continuously issued new policy documents to regulate the development of the medical device industry. Since the announcement of the first 75 medical device industry standards in 2009, a total of 41 announcements regulating medical device industry standards have been successively released, covering industry standards for more than 1,100 types of medical devices.

Among these, Announcement No. 60 issued by the National Medical Products Administration (NMPA) in 2019 stated: “PreimplantationChromosomal AneuploidyDetection Kit (Sequencing Method)” i.e., Preimplantation Genetic Testing for Aneuploidies(PGT-A) test kits were included for the first time in the national mandatory industry standards for medical devices, which came into effect on August 1, 2020.. Prior to this, PGT-A kits had remained in a regulatory void, lacking both standards and oversight.

Excerpted from Document No. 60 of 2019 issued by the National Medical Products Administration 

The inclusion of the PGT-A kit in the national mandatory pharmaceutical industry standards signifies the National Medical Products Administration’s (NMPA) heightened attention to and emphasis on the third-generation IVF market. It is foreseeable that the NMPA will strengthen strict regulation of testing kits related to third-generation IVF, thereby promoting compliance within the industry and accelerating the consolidation and reshuffling of the assisted reproductive technology sector.

PGT-A kits are classified as Class III medical devices., in accordance with the mandatory provisions of national laws and regulations on medical devices,Any medical institution (including hospitals, medical laboratories, and medical testing centers) must use medical devices with registration certificates when carrying out clinical application projects, and the platform on which product development relies must also obtain a Class III medical device registration certificate.。

Class III medical devices are the highest-risk category of medical devices in China, requiring special measures for strict control and management to ensure their safety and effectiveness. Class III medical devices generally refer to those that pose potential risks to the human body, need to be implanted into the human body, and are used to support and sustain life.

According to the public notice released on the official website of the National Medical Products Administration, PGT-A kits have already been approved for marketing in China. As early as February this year,Suzhou Beikang Medical Instrument Co., Ltd.(abbreviated as: Beikang Medical) the PGT-A third-generation IVF testing kit developed byCertified as a Class III Medical Device by the NMPA, andApproved for market launch (NMPA Registration No.: 20203400181)。

It is worth mentioning that this isChina's First PGT-A Testing Product Approved by the NMPA, also isThe only officially approved third-generation IVF product currently availableThe launch of this kit not only fills the technological gap in the application of third-generation IVF in China, marking the official entry of PGT-A testing for third-generation IVF into an era of certified products, but also alleviates the predicament of lacking legally approved third-generation IVF products domestically.

According to clinical data released by Beikang Medical, this PGT-A product can increase the average pregnancy rate of IVF to 72% and reduce the average miscarriage rate to 6.9%.

Under the oversight of mandatory national standards for the pharmaceutical industry, PGT-A kits will be required to obtain regulatory approval before market entry. This unified framework will standardize industry development, eliminate the current disparity in testing quality, ensure the accuracy of clinical test results for third-generation IVF, effectively safeguard the interests of expectant mothers, and reduce medical disputes.

Assisted reproductive technology (ART) institutions shall strictly comply with national mandatory pharmaceutical industry standards, ensuring thatLegal, Compliant, and Qualified, facilitating the maturation, standardization, and industrialization of third-generation IVF products.

Suzhou Beikang Medical Instrument Co., Ltd., established in 2010, is a leading enterprise in the reproductive health niche market. It operates four independent medical laboratories and 31 joint laboratories across China. Focusing on the application and research of genetic technologies in the field of reproduction, the company has innovatively developed products covering the entire reproductive lifecycle—preconception, prenatal, and neonatal—based on clinical needs, thereby establishing three robust lines of defense to reduce birth defects.