From April 1, 2024, China’s radiofrequency (RF) beauty device industry will face a major shake-up as the government introduces stringent regulations, classifying these devices as class 3 medical devices. This move surpasses the regulations set by the U.S. FDA and is poised to significantly impact Chinese manufacturers while simultaneously creating lucrative opportunities for American companies in this sector. Euromonitor International reports that China’s market for small personal care appliances, notably driven by RF beauty devices, soared to $5.6 billion in 2023, marking a steady growth with a 4.8% CAGR since 2018. This segment, which has been a magnet for new businesses, is now at a crossroads with the upcoming regulatory changes.
The 2024 regulations, announced by the China Center for Device Evaluation of the State Food and Drug Administration, will treat RF beauty devices as high-level medical devices. This new classification is expected to bring about major changes in the market, increasing production and operational costs for manufacturers. As a result, many existing products might be pulled from the market due to the heightened costs associated with these new requirements.
Part of the new regulation includes mandatory and expensive clinical trials for new products, estimated to cost between 4 to 5 million yuan. This could deter many companies from launching new products in the post-April 2024 era.
This move is in line with China’s recent trend of enforcing strict regulations across different sectors. Previous actions in online gaming and education have led to significant impacts on major domestic companies, including massive job losses.
Although the Chinese government has been focusing on economic growth, these regulatory crackdowns have had mixed effects on businesses. “No sector is safe from China’s crackdown.” said tech analyst Jordan Schneider during a CNBC interview
With the upcoming changes, products formerly categorized as simple household appliances will now be treated as Class III medical devices. Companies have been given a two-year window to comply, a challenging task given the complexity of the regulatory process.
In contrast, the U.S. FDA’s approach to medical device classification, which is based on risk assessment, appears less stringent compared to China’s new regulations.
China’s decision not to exempt low-energy, low-risk devices from these strict controls has led to a broad and challenging regulatory landscape for companies.
These stringent new rules in China cast a shadow over its beauty device industry, potentially spelling the end of a $5.6 billion market and impacting a million jobs from April 2024.
However, this presents a prime opportunity for U.S. RF beauty device companies. The U.S. boasts a strong presence in this market, with 11 out of 19 major players in the RF microneedling market, as per Data Bridge Market Research. The challenges faced by Chinese companies could open doors for American firms to capture a significant share of China’s growing beauty device market.
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