Requirements for Applying for Medical Device Operation License
- Covering ‘operation of medical devices’ in the company’s business scopes: An application for the operation of medical devices must be submitted based on a company entity whose main business scope focuses on the operation of medical devices. Ensuring a related and comprehensive business scope should be planned as you register your WFOE in China.
- 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.
- Ensuring compliance with practical operating conditions: In other words, the place 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.
Comparison of the Differences between Three Classes of Medical Device Operation Licenses
| Class I | Class II | Class III | |
| Scope of Application | Low-risk medical devices | Medium-risk medical devices | High-risk medical devices |
| Description | These devices have low risk and typically include non-invasive, low-risk products. | Devices in this category pose a moderate level of risk and include products that require invasion into the body, with higher associated risks. | These devices are considered high-risk products, often involving complex technologies and invasive procedures. |
| Examples of instruments | Surgical instruments, X-ray films, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags, regular hospital beds, wheelchairs, etc. | Adhesive bandages, condoms, thermometers, blood pressure monitors, oxygen concentrators, nebulizers, etc. | Infusion sets, syringes, intravenous catheters, cardiac stents, ventilators, CT scanners, magnetic resonance imaging (MRI), pacemakers, artificial heart valves, artificial joints, etc. |
| Application method | No additional application is required. | Submit a record application for approval to the municipal department responsible for drug supervision and management. | Submit an application to the municipal Administration for Market Regulation in your city (on-site inspection is required). |
| Personnel Requirements | Basic qualifications for key personnel only. |
At least 1 professional with expertise in medical devices for wholesale enterprises dealing with no more than 8 categories of products. At least 2 full-time quality management personnel are required, with at least 1 person possessing expertise in medical devices for enterprises dealing with more than 8 categories of products. |
Over 5 employees, with at least 1 person possessing a professional educational background in medical devices or a related field*. Additional requirements need to be met for specific categories of medical devices, such as contact lenses, IVD, and invasive and implantable medical devices. |
* 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
- Establish a company as the business entity (usually a WFOE) and obtain a business license: If you want to engage in the 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!
- 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!
- 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!
- Recruit employees: Due to the nature that the 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!
- 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.
