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Medical Device Operation License Application

Setting up medical device companies in China is becoming more common. Hongda supports classification checks, document preparation and the application for a medical device operation license.

Classification checks
Document preparation
Application support

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Requirements

Requirements for Applying for a Medical Device Operation License

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.

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.

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 a “Class III License”, a qualified warehouse is mandatory. Premises, staffing and management software must meet the requirements for the products and the local authority.

Classes

Differences Between the Three Classes of Medical Device Operation Licenses

Class I devices have low risk and typically include non-invasive, low-risk products. Class II devices pose a moderate level of risk. Class III devices are considered high-risk products, often involving complex technologies and invasive procedures.

Different types of medical devices may fall into different classes where application materials and requirements vary.

Personnel

Personnel Requirements by Class

Personnel requirements differ by class:

Class I: basic qualifications for key personnel only
Class II: at least 1 professional with expertise in medical devices for wholesale enterprises dealing with no more than 8 categories of products
Class II: at least 2 full-time quality management personnel, with at least 1 person possessing expertise in medical devices for enterprises dealing with more than 8 categories of products

Class III: staffing as required for the products, including personnel with a professional background in medical devices or a related field
Class III: additional requirements for specific categories, 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.

How it works

The application for a medical device operation license, step by step.

Quick answer: the application runs in five steps, from establishing the company to applying for the license. Select a step for detail.

Stage 1 of 5

Establish the company

Establish a company as the business entity (usually a WFOE) and obtain a business license.

If the business involves cross-border trades of medical devices, an Import and Export License is also required.

If you already have a company

Already Have Your Company for the Application?

If your company is already registered, the application follows these steps.

Steps one and two

Step One: Understand relevant laws and regulations. Before applying, it is crucial to have a solid understanding of the relevant laws and regulations, which can be acquired through the official website of the National Medical Products Administration.

Step Two: Qualification review application. Prepare the necessary documentation for a qualification review, which verifies whether the applicant meets the conditions for operating medical devices. Required documents include the business license and the legal representative’s identification, along with other supporting materials.

Steps three and four

Step Three: Submission of application materials. 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.

Step Four: On-site assessment. The government conducts an on-site assessment of the company, covering 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.

Requirements and maintenance

Premises, Quality Management and Cancellation

Premises and quality management

Your business premises and warehouses must fit the business scope and scale. Warehouses should meet storage requirements, have necessary facilities like light-proofing ones, and for those with special storage needs (e.g., cold chain products), proper conditions must be provided.

Your enterprise should establish and maintain an effective quality management system covering procurement, acceptance, storage, sales, transportation and after-sales service, ensuring the traceability of medical device quality and safety, like having an incoming inspection record system.

If you stop the business

Why Hongda

Why Choose Hongda for a Medical Device Licence?

Coordinate the licence with the company setup around it, with one China-based service team.

Since 2007

Serving foreign companies in China since 2007, with client relationships that go back to 2008.

One team, end to end

Company setup, banking, tax, payroll and work permits coordinated by one team.

In English, on the ground

English-language project management with a China-based team in seven locations.

Clear scope and limits

We confirm the scope before work begins and say which decisions rest with authorities or banks.

Trusted by companies including

Client voices

Clients who have stayed with us for years.

Travis Perkins

David Finch BA ACMA CMIIA CAMA

Director of Group Business Risk & Assurance, Travis Perkins PLC

With Hongda since 2008

Travis Perkins PLC (a leading builders merchant in the UK) has been using Hongda Business Services since 2008 for accounting and professional services. Throughout this time, we have found the team at Hongda to be very helpful and professional in their dealings with us. We look forward to working with the company in the future.

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Your team

The people you will work with.

Meet the three chief consultants at Hongda, including founder Angel Ho and co-founder Bobby Lee.

Angel Ho

Chief Consultant, CEO

Founder of Hongda in 2007. Holds Chinese Tax Agent, IPA (Australia) and IFA (UK) certificates. Provides one-stop services covering market access, company establishment, financial settlement, financial and tax consultation, and human resources management.

Bobby Lee

Chief Consultant

Co-founder of Hongda. Many years of corporate legal consultancy and involvement in managing client enterprises. Familiar with tax, personnel and project management work across Guangdong, Hong Kong and Macau. Excellent English communication skills.

Strong Song

Chief Consultant

24 years in enterprise management, business development, and financial and tax compliance. Has provided financial and tax advisory services for hundreds of companies. In-depth learning and practical experience in IFRS (International Financial Reporting Standards), Generally Accepted Auditing Standards and International Taxation.

Meet the full team

FAQ

Medical Device Licence FAQs

Practical answers about requirements and cancellation.

Ask your question

What should I do with the license if my enterprise no longer engages in the business of medical devices?

If your enterprise voluntarily terminates the business of medical devices, you shall apply to the original issuing department for the cancellation of the “Medical Device Business License”. You are required to submit the cancellation application and relevant supporting materials, such as the statement that the inventory has been cleared. After being approved by the original issuing department, the license will be cancelled and the corresponding business termination procedures will be completed.

What are the requirements for personnel when I apply for the medical device business license?

Different categories of medical devices have different requirements. For Class III medical devices, your enterprise needs a quality management organization or qualified personnel with relevant professional degrees or titles. Staff in acceptance, etc. should have corresponding knowledge and capabilities. For in vitro diagnostic reagents, relevant staff need a lab medicine background.

What are the regulations on the business premises and warehouses for my enterprise?

What are the essential requirements for my enterprise’s quality management system?

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Medical Device Operation License Application

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Requirements for Applying for a Medical Device Operation License

Differences Between the Three Classes of Medical Device Operation Licenses

Personnel Requirements by Class