profeesional ISO13485 ISO9001certification for mask and protective clothing

about us
Founded in2005,Sunchine Inspection,with offices in China and in Europe, Sunchine Inspection has become one of the best third party inspection companies in China,serving over 1200 regular clients in various fields,from all the Continents in the world.
Our Certification:
Description of FDA
FDA is the abbreviation of U.S. Food and Drug Administration. It is the authoritative body of international medical audit. It is the highest law enforcement agency specializing in food and drug management authorized by the U.S. Congress, that is, the federal government. FDA is a government health regulatory agency composed of doctors, lawyers, microbiologists, pharmacologists, chemists and statisticians dedicated to protecting, promoting and improving national health. Food, medicine, cosmetics and medical devices certified by FDA are safe and effective for human body. In the United States and nearly a hundred other countries, only through the FDA approved materials, devices and technologies can commercial clinical applications be carried out.
Question 1: Which institution issued the FDA certificate?
Answer: There is no certificate for FDA registration. Products will be registered with FDA and get the registration number. FDA will send a reply to the applicant (signed by the Chief Executive of FDA), but there is no FDA certificate.
Question 2: Does FDA need a designated certification laboratory test?
A: The FDA is a law enforcement agency, not a service agency. If someone says they are affiliated with the FDA, they are at least misleading consumers, because the FDA has neither a public-oriented service certification body nor laboratories, nor so-called "designated laboratories". The FDA, as a federal law enforcement agency, can't be a referee or an athlete. FDA will only recognize the GMP quality of service testing laboratories and issue qualified certificates, but will not "designate" or recommend a specific one or several to the public.
Question 3: Does FDA registration necessarily require an American agent?
A: Yes, Chinese applicants must appoint an American citizen (company/association) as their agent when they register for FDA. The agent is responsible for the process service in the United States and is the medium to contact FDA and applicants.
Our advantage
*One multi-language team combined with Chinese and Western Expertise.
*One experienced Consulant/Advisor Team+Acccrediatedd inspector team.
*Quick reaction service and online security payment system
*Strict European Quality Standard for Inspection +Inspector selected according to product classificitation.
We don’t produce goods, but we create Values;
We don’t sell products, but we build up Confidence,
We don’t export cargos, but we are the symbol of Insurance.
The clients choose us, because we know better their Needs.