Requirements for Applying for a Medical Device Business License

• Covering the “medical device operation” within the company’s business scope: The application for medical device operation must be submitted based on the company entity whose main business scope is medical device operation. When registering a wholly foreign-owned enterprise in China, it is necessary to ensure the planning of relevant and comprehensive business scope
• Meet mandatory requirements for different categories: According to Chinese industry standards, the operation of medical devices can be further divided into three categories (Class 1, Class 2, and Class 3) with different requirements. Different types of medical devices may be classified into different categories, with different application materials and requirements
• Ensure compliance with actual operating conditions: In other words, the place where you store medical equipment or operate must comply with public supervision and inspection requirements. For example, for a Class III license, there must be a qualified warehouse. The office area should not be less than 60 square meters, with at least 5 employees (including at least 1 professional with a background in the medical device field), and equipped with specialized medical device management software

Comparison of Differences in Three Types of Medical Device Business Licenses

	Class I	Class II	Class III
Scope of application	Low risk medical devices	Medium risk medical equipment	High risk medical equipment
Describe	These devices have low risk and typically include non-invasive low-risk products	This type of device has moderate risk, including products that need to invade the body, with higher associated risks	These devices are considered high-risk products, typically involving complex technology and invasive procedures
Instrument Example	Surgical instruments, X-rays, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags, general hospital beds, wheelchairs, etc	Tape, condom, thermometer, blood pressure monitor, oxygen concentrator, spray, etc	Infusion sets, syringes, venous catheters, cardiac stents, ventilators, CT scanners, magnetic resonance imaging (MRI), pacemakers, artificial heart valves, artificial joints, etc
Usage	No additional application is required	Submit a filing application for approval to the municipal drug regulatory department	Submit an application to the Market Supervision Bureau of the city where you are located (on-site inspection is required)
Personnel requirements	Only for the basic qualifications of key personnel	At least one professional provides professional knowledge in medical devices for wholesale enterprises that operate no more than 8 types of products. Enterprises involving more than 8 types of products require at least 2 full-time quality management personnel, including at least 1 person with professional knowledge in medical devices	More than 5 employees, at least 1 of whom has a professional education background in medical devices or related fields. Additional requirements for specific categories of medical devices need to be met, such as contact lenses IVD、 Invasive and implantable medical devices

*Medical device expertise includes medical devices, biomedical engineering, mechanical engineering, electronics, medicine, biotechnology, chemistry, pharmacy, nursing, rehabilitation, laboratory medicine, management, and related disciplines.

Gradually apply for a medical device business license

• Establishing a company as a business entity (usually a wholly foreign-owned enterprise) and obtaining a business license: If you want to engage in the medical device business industry, you need to register a company as the main operating entity, covering the “medical device business” project in your business scope. Hongda will assist you in completing this process and provide all necessary assistance so that you do not have to worry about compliance requirements when determining the scope of business
• Open a bank account and register for taxation: Hongda can also help you keep financial records and declare taxes through our bookkeeping services. For more information, please visit our accounting service page
• Establishing offices and warehouses: The government has established standards for the offices and operating areas of any medical device company, including location, size, fire control, and other standards. Ensure that your ideal location meets all requirements, or let Hongda help you
• Recruitment of employees: Due to the nature of the medical device industry involving high-tech operations and understanding of complex technical indicators, comprehensive knowledge in this field is required. Therefore, it is necessary to evaluate and review the education and professional qualifications of employees in accordance with relevant laws and regulations. Hongda can also help you
• Applying for a Medical Device Business License: Prepare all necessary materials and documents and submit the application for the Medical Device Business License for approval! If the business involves cross-border trade of medical devices, an import and export license is also required. But don’t worry, Hongda will help you complete all of this

Has your company already applied?

Step 1: Understand relevant laws and regulations
Before applying for a medical device business license, it is necessary to fully understand the relevant laws and regulations. Familiarity with these regulations is crucial to avoid errors in the license application process. These knowledge can be obtained through the official website of the National Medical Products Administration or other regulatory inquiry websites. However, the simplest way is to collaborate with HTC and let us tell you everything you need to know!

Step 2: Qualification Review Application
After understanding the applicable laws and regulations, the next step is to prepare the necessary documents for qualification review. The purpose of this review is to verify whether the applicant meets the operating conditions for medical devices. The required documents include business license, organization code certificate, tax registration certificate, legal representative identity certificate, and other supporting materials.

Step 3: Submit application materials
Submitting application materials is a crucial step in obtaining a medical device business license. Before submission, it is necessary to thoroughly understand the relevant regulations and the specific documents required. The application materials usually include a business plan, medical device product catalog, quality management and financial system documents, as well as qualification certificates of relevant personnel. Hongda will help you overcome difficulties with the promise of “no success, no charge”. Take it easy!

Step 4: On site evaluation
After submitting the application materials, the government will conduct an on-site evaluation of the company. This evaluation includes aspects such as warehouse size, equipment, number of office personnel, and assessment of product quality management system.

Step 5: Approval!
After on-site evaluation, the application will go through the approval process. Upon approval, the company will obtain the Medical Device Business License. If not approved, it is necessary to explain the reasons for rejection and may require resubmission of the application.

Why choose Simon?

Rapid Processing

With experienced team members, we can handle your project faster than others.

Unsuccessful, no charge

Simon promises that we will only charge after your project is successfully completed.

Tailored services

We will provide the most suitable business plan based on your situation.

Traceable process

Simon has an online system for you to track any updates to the project.

Frequently Asked Questions

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