The first domestic "Class III Medical Device Certificate" for radiofrequency microneedles has been awarded to Peninsula Medical
The radiofrequency microneedle device "Bendao Counterclockwise" from Bendao Medical received its first domestic Class III medical device certification on October 29, becoming the first Class III radiofrequency microneedle to obtain dual certification from NMPA and FDA. This move aligns with regulatory directions and accelerates the company's efforts to meet Class III standards, seizing market initiative. The device integrates multiple radiofrequency modes and is primarily used for acne treatment, expected to promote the expansion of domestic radiofrequency products. Regulatory upgrades will drive the industry to transition from quantity expansion to quality competition
The first "Class III Medical Device Certificate" for domestic radiofrequency microneedles (commonly known as "gold microneedles") has arrived.
On October 29, Peninsula Medical announced that its radiofrequency skin treatment device (hereinafter referred to as "Peninsula Counterclockwise") has officially obtained the Class III medical device registration certificate.
This is the first domestic gold microneedle device to obtain the "Class III Medical Device Certificate."
Prior to this, Peninsula Counterclockwise had already obtained FDA 510(k) registration, and with this approval of the domestic "Class III Medical Device Certificate," it has become the first domestic radiofrequency microneedle with dual certification from NMPA and FDA.
The approval of the "Class III Medical Device Certificate" aligns with the regulatory direction of relevant authorities regarding radiofrequency products such as gold microneedles.
In July 2024, the National Medical Products Administration issued a notice titled "Announcement on Further Clarifying the Requirements for Radiofrequency Treatment Devices," which requires that starting from April 1, 2026, radiofrequency treatment devices and radiofrequency skin treatment devices must upgrade from Class II medical device certificates to Class III medical device registration certificates.
This has prompted Peninsula Medical and many other companies to accelerate their alignment with the "Class III Medical Device Certificate" standards to seize the market initiative after the regulatory upgrade.
According to Peninsula Medical, "Peninsula Counterclockwise" integrates monopolar, bipolar, and combined monopolar-bipolar modes of radiofrequency microneedling. With the addition of "dynamic layering technology," it addresses the treatment of different skin areas while ensuring concentrated energy output, eliminating the need for multiple treatments to meet different needs as in traditional projects, thus saving time costs and significantly reducing discomfort during the treatment process, primarily used for treating acne.
With the approval of Peninsula Counterclockwise, domestic radiofrequency products are expected to see expansion.
Xinfeng noted that in March of this year, Huadong Medicine (000963.SZ) had its optical radiofrequency treatment device V30 "Class III Medical Device Certificate" application accepted by the National Medical Products Administration.
Unlike "Peninsula Counterclockwise," which uses microneedling treatment, Huadong Medicine's V30 primarily utilizes laser energy, integrating radiofrequency, intense pulsed light, and Nd:YAG laser energy sources, intended for skin tightening, hair removal, vascular and pigment lesions, and acne treatment.
Overall, the regulatory upgrade has not restricted industry development; instead, it has filtered out companies with stronger technical capabilities through "compliance thresholds," promoting the transformation of domestic radiofrequency products from quantity expansion to quality competition, further accelerating the process of domestic substitution.
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