This 2024, Qualtech secured the first-ever approval for Hyaluronic Acid Dermal Fillers in China solely through a Clinical Evaluation Report (CER). This milestone not only underscores the efficacy of Qualtech’s medical writing team but also sets a new precedent in the medical aesthetic industry.
This article delves into the details of how Qualtech was able to achieve this feat.
The Product: What is a Hyaluronic Acid Dermal Filler?
A hyaluronic acid dermal filler is a cosmetic product that is injected into the skin to smooth wrinkles, add volume, and sculpt facial features. This specific dermal filler is made with hyaluronic acid (HA), a naturally occurring substance that plays an important role in keeping your skin hydrated and plump.
Because hyaluronic acid dermal fillers are a non-surgical option to address wrinkles, fine lines, and facial volume loss, it is widely used because of the minimally invasive cosmetic procedures for facial contouring and augmentation.
The Market: Why China?
The allure of China’s market for medical aesthetics is undeniable.
According to a 2023 report from Deloitte, the spending power of China’s urban residents increased with a CAGR of 35% in the last 5 years. This rise in the per capita disposable income only highlights the potential of China’s consumer market.
With a burgeoning middle class, along with a cultural emphasis on youthful aesthetics and a growing acceptance of aesthetic enhancements, China presents a lucrative landscape for innovative medical solutions.
The Complexity: What were the Regulatory Challenges Faced in China?
China’s medical device regulatory framework is notoriously intricate. Not only is the required documentation complex, but testing is also a rigorous process.
How so?
The mandate for local clinical trial results added an extra layer of complexity that led to a more time-consuming and resource-intensive endeavor. This requirement can lead to delays and uncertainties in product launch timelines, posing a substantial hurdle for medical device companies aiming to enter the Chinese market.
The Solution: What was Qualtech's Strategic Edge?
Despite all the challenges, Qualtech’s experienced medical writing team adeptly managed by:
- Having an advanced CER project management strategy,
- Producing an extensive CER, and
- Providing immediate and qualified responses to the reviewer’s inquiries.
The Outcome: What exactly did Qualtech Accomplish?
The approval of Qualtech’s Hyaluronic Acid Dermal Fillers is a pioneering milestone, marking the first instance of a product category earning regulatory approval based entirely on a detailed CER.
This achievement has enabled remarkably quick registration approval within 2.5 years, facilitating faster market entry and providing Qualtech with a strategic advantage in the competitive landscap
Qualtech Consulting Corporation’s achievement in obtaining regulatory approval for Hyaluronic Acid Dermal Fillers through only a CER is a testament to the power of innovation and strategic regulatory planning. It highlights the importance of a dedicated and skilled medical writing team.
The Bottomline
Qualtech Consulting Corporation’s achievement in obtaining regulatory approval for Hyaluronic Acid Dermal Fillers through only a CER is a testament to the power of innovation and strategic regulatory planning. It highlights the importance of a dedicated and skilled medical writing team.
