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Secondary medical device production license,Is it easy to obtain a Class II medical device certificate?

If you want to apply for a Class II medical device license, you can read this article! If you want to produce and operate Class II medical device equipment facilities in Shenzhen, such as:Face mask、Forehead thermometer、Infrared thermometer and other equipment,You need to apply for a Class II medical device license,Own

Process

Unfamiliar、Trouble and effort。Hong Kong Xintong International is a professional qualification agency company,Professional handling of rare qualifications、Qualification

Process

familiar、Processing speed is fast。Can provide you with fast professional qualification processing services。

Make the whole process easier for you、Worry free、Get your license easily,Can be put into legal and compliant production faster to create greater benefits。

Materials required for Class II medical devices and

Process

  1. Class II medical device business registration form;
  2. business license(It can only be based on the company as the main body)and a copy of the organization code certificate;
  3. legal representative、Business person in charge、Proof of identity of the quality manager、Copy of academic qualification or professional title certificate;
  4. Organizational Structure and Department Setup Instructions;
  5. Business scope、Description of business methods;
  6. Business premises、Geographical location map of warehouse address、floor plan、Property ownership certificate or a copy of the lease certificate issued by the house leasing agency;
  7. Business facilities、Device catalog;
  8. Operation quality management system、Work program and other file directories;
  9. Certificate of authorization of the person in charge;
  10. Other supporting materials (such as operating in vitro diagnostic reagents,According to the business standards for applying for in vitro diagnostic reagents

Require

Provide additional materials such as medical laboratory personnel and cold chain facilities and equipment)。

As our pace of life accelerates,Many needs require professional and quick solutions,If you are dealing with rare qualifications。If you still choose to do it yourself。Market opportunities will be missed。The issue of this qualification has not yet been handed over to a professional team.,Provide you with professional services。Hong Kong Xintong International has 13 years of experience in professional qualification processing。Save you trouble、Get the documents you need quickly and easily。

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