November 19, 2021, after more than two years of unremitting efforts, Pingchuang Medical finally passed the FDA 510(K) certification today! This means that our products have gained access to the US market.
First, What is FDA 510(K) certification?
510(K), in essence, is the "product listing registration" that must be done before medical products are marketed and sold in the United States. It is a section of the U.S. Food, Drug and Cosmetic (FD&C) Action Committee Act, and this section of the Act, which happens to be in the U.S. FD&C Act Section 510, so many people habitually refer to it as 510(K). Together is the FDA 510(K).
Second, what are the advantages of passing the FDA 510(K) certification?
According to the requirements of this 510(K) section of the Act, all medical devices introduced into the U.S. market, are required to meet the requirements of this Act, those not exempt from 510(K) Class I or Class II or Class III medical devices, must do "product listing registration", so this product listing registration, which is usually we So this product listing is what we usually call FDA 510(K) certification.
Therefore, if you want to export Class I, Class II, or Class III medical devices that are not exempt from 510(K) to the United States, you must first pass FDA 510(K) certification, and you can clearly see that the U.S. trade deficit with China has been increasing in the past two years, and as early as May 2020, China has leaped to become the largest U.S. deficit, and also the largest trading partner.
After the outbreak of the global epidemic, the U.S. imports of Chinese medical devices are very exaggerated, Chinese production of masks, disinfectant, respirators and other types of medical devices in short supply, in addition to epidemic prevention medical products, China exports a large number of a class of products to the United States every year, that is, human lubricants. In China, human lubricants are classified as civilian products, and the jurisdiction is slightly more lenient. However, the United States classifies human lubricant as Class II medical device, which undoubtedly raises the threshold of exporting human lubricant to the United States, and there is great profit space for human lubricant export to the United States, but because human lubricant belongs to Class II medical device, so it needs to pass the FDA certification first, this step has stuck more than 99% of manufacturers, although many human lubricant manufacturers Although a lot of human lubricant manufacturers come to us, but the long time and difficulty of applying for FDA certification make them back out.
Third. Company's future prospect
Since its establishment, Pingchuang Medical has been deeply engaged in the field of medical devices, and has obtained 6 independent invention patents, 18 utility model patents, ISO13485, US FDA, EU CE certification, US FDA 510(K) certification, etc. The medical device products produced by Pingchuang Medical have been used in 1000+ hospitals nationwide for long-term clinical use, and the quality is well known. In addition, our medical devices and human lubricants are also exported to Europe, America, Korea and Japan, etc. This FDA 510(K) certification also clears the hurdle for our company to export our medical devices and human lubricants to America, which is a crucial step.
Of course, passing FDA 510(K) certification is far from the end, our company will be more strict in product quality control, so as to alleviate the difficulties in export qualification certification and let our products go to the world faster and wider!
