Class II Medical Devices are those within the scope regulated by the medical device supervision and administration department, and categorized as lower-risk medical devices.
However, if they are to be sold in the international market, they need to obtain foreign certification standards such as ISO, CE, and FDA.
Some manufacturers have only obtained the medical device production license in China, without obtaining foreign certification standards. Therefore, these manufacturers often lower product prices due to the lack of international certification, thus gaining a competitive advantage in the market.
Obtaining international certification standards such as ISO, CE, and FDA requires significant financial and time investment (up to 2 years). For example, the maintenance cost of CE certification is high (approximately $15,000), and the initial application fee is also considerable (approximately $150,000).
Moreover, with the refinement of related regulations, the certification process becomes more complex and time-consuming. Additionally, the CE certification renewal period is long, and the review standards during the application process are increasingly stringent, adding to the difficulty of application.
Despite the substantial resources required to obtain international certification standards, they provide robust assurance of product quality and safety. This can enhance the competitiveness of products in the market and gain more recognition and trust in international markets. Therefore, although lower-priced products may attract some customers, many still prefer products with international certification standards when it comes to pursuing product quality and safety.
