Medical Device Operation License Application

Requirements for Applying for Medical Device Operation License

1. 

   Covering ‘operation of medical device’ in the company’s business scopes: Application for the operation of medical devices must be submitted based on a company entity whose main business scope focuses on the operation medical device. Ensuring a related and comprehensive business scope should be planned as you register your WFOE in China.

2. Meeting the compulsory requirements of different classifications: According to China’s industry standards: the operation of medical devices can be further divided into three classes (Class I, Class II, and Class III) with different requirements. Different types of medical devices may fall into different classes where application materials and requirements vary.

3. Ensuring the compliance with practical operating conditions: In other words, the place s where you will be storing your medical devices or running your operation must meet the requirements for public supervision and inspection purposes. For example, for a "Class III License," a qualified warehouse is mandatory. The office space should not be less than 60 square meters, with a minimum of 5 employees (including at least 1 professional with previous background in the medical device field) and equipped with dedicated medical device management software.
   

Please see the following table for the comparison of the differences between those three classes of Medical Device Operation Licenses.

*Professional expertise in medical devices includes fields such as medical devices, biomedical engineering, mechanical engineering, electronics, medicine, bioengineering, chemistry, pharmacy, nursing, rehabilitation, laboratory medicine, management, and related disciplines.

Application of Medical Device Operation License Step-by-Step

1. Establish a company as the business entity (usually a WFOE) and obtain a business license: If you want to engage in medical device operation industry, you need to register a company as the main business entity, covering the item ‘medical device operation’ in your operation scope. Hongda will help you through this process and provide all necessary assistance so that you don’t need to worry about the compliance requirements about determining your business scope!
2. Open a bank account and register for taxation: Hongda can also help you keep your financial records and report your taxes with our bookkeeping services. Please visit our bookkeeping service page for more information!
3. Set up an office and warehouse: The government has set regulations on the standards of the office and operation areas of any medical device companies, including location, sizes, fire controls, and other criteria. Make sure your ideal location meets all the requirements or let Hongda help you!
4. Recruit employees: Due to the nature that medical device industry involves high-tech operation and understanding of complex technical indicators, which requires comprehensive knowledge within this field, the educational and professional qualifications of the employees need to be assessed and examined, according to related laws and regulations. Hongda can also help you with this!
5. Apply for a Medical Device Operation License: Prepare all the materials and documents needed and submit the application for your Medical Device Operation License to be approved! If the business involves cross-border trades of medical devices, an Import and Export License is also required. But no worries as Hongda will help you with all these!

Already Have Your Company for Application?

Step One: Understand Relevant Laws and Regulations

Before applying for a Medical Device Operation License, it is crucial to have a solid understanding of the relevant laws and regulations. Familiarity with these regulations is essential to avoid errors during the license application process. This knowledge can be acquired through the official website of the National Medical Products Administration or other regulation inquiry websites. The easiest way to do so, however, is to work with Hongda and let us tell you everything you need to know!

Step Two: Qualification Review Application

After gaining knowledge of the applicable laws and regulations, the next step is to prepare the necessary documentation for a qualification review. This review is conducted to verify whether the applicant meets the conditions for operating medical devices. Required documents include the business license, organization code certificate, tax registration certificate, and the legal representative's identification, along with other supporting materials.

Step Three: Submission of Application Materials

Submitting the application materials is a critical step in obtaining a Medical Device Operation License. Before submission, it is essential to thoroughly understand the relevant regulations and the specific documentation required. Application materials typically include a business plan, a catalog of medical device products, quality management and financial system documentation, and proof of qualifications for relevant personnel. Hongda will help you all the way through with our ‘no success, no charge’ promise. Just relax!

Step Four: On-Site Assessment

Following the submission of application materials, the government will conduct an on-site assessment of the company. This assessment covers aspects such as warehouse size, equipment, office staff numbers, and an evaluation of the product quality management system.

Step Five: Approval!

After the on-site assessment, the application undergoes an approval process. If approved, the company will receive the Medical Device Operation License. In the event of non-approval, addressing the reasons for rejection is necessary, and the application may need to be resubmitted.

What Makes Hongda Your Ideal Partner

As you may be aware, the medical device industry is governed by complex regulations and approval processes to ensure public safety. At Hongda, we offer comprehensive one-stop services, from company registration to obtaining a Medical Device Operation License. Our professional team will accompany you throughout the process, ensuring precision and efficiency at every step. Whether it's product registration, quality management system certification, or market access strategy, we provide tailored solutions to meet your specific needs.

• Business License Registration: Before you embark on your journey to China, we can assist you in properly handling your company's business license. Our team will ensure a smooth and efficient process, regardless of your location.
• Preparatory Planning: We do more than just handle your business license; we also start the preparatory work for your Medical Device Operation License application before you arrive in China. Our goal is to ensure that you can commence operations immediately upon arrival, without wasting precious time on administrative procedures.
• Site Leasing and Employee Recruitment: Beyond administrative tasks, we offer site leasing recommendations and professional recruitment services to ensure your enterprise complies with all regulations and standards from the outset.

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