Conditions for establishing a medical equipment trading company

Article overview

Established a medical equipment trading company today not only meets market demand but also creates great opportunities for entrepreneurs. In a context where society increasingly focuses on health and safety, providing high quality medical equipment is extremely necessary. However, to turn this idea into reality, businesses need to prepare carefully and clearly understand the legal conditions and quality standards. In the following article, Long Phan will work with customers to clarify the above regulations.

Established a medical equipment trading company
Established a medical equipment trading company

Classification of medical equipment

Pursuant to the provisions of Article 4 of Decree 98/2021/ND-CP, medical equipment is classified into 4 types A, B, C and D based on the level of potential risk:

  • Type A: Medical equipment with low risk level.
  • Type B: Medical equipment with low-medium risk level.
  • Type C: Medical equipment with medium-high risk level.
  • Type D: Medical equipment with a high level of risk.

This classification plays an important role in determining the legal requirements and business registration process for each type of medical equipment. Businesses need to clearly understand this classification to ensure compliance with legal regulations during business processes.

Conditions for establishing a medical equipment trading company

Conditions for establishing a medical equipment trading company

To establish a medical equipment business, a business needs to meet the following conditions:

  • Charter capital: According to Clause 34, Article 4 of the Enterprise Law 2020, charter capital is the total value of assets contributed or committed to be contributed by members. Currently, the law does not stipulate a minimum capital level, except for some specific industries.
  • Subject of establishment: Pursuant to Clauses 1 and 2, Article 17 of the Law on Enterprises 2020, all organizations and individuals have the right to establish enterprises, except for some cases prohibited by regulations.
  • Business lines: Enterprises are allowed to register for business lines that are not prohibited by law. For conditional business lines, enterprises must meet the conditions prescribed in Article 27 of the Enterprise Law 2020 and Clause 9, Article 2 of the Investment Law 2020.

Conditions for medical equipment business

According to Decree 98/2021/ND-CP specifically regulating medical equipment business conditions, including:

Conditions for medical equipment manufacturing facilities

  1. Need to meet ISO 13485 quality management system standards.
  2. For equipment containing drugs and precursors, it is necessary to establish a management tracking system and separate storage area.

Conditions for facilities to purchase medical equipment

  1. The facility needs to have at least 01 technical staff with a college degree or higher, majoring in engineering, medicine, pharmacy, chemistry, biology or medical equipment engineering, appropriate to the type of equipment that trading facility.
  2. It is necessary to have storage warehouses and transportation vehicles that meet the following minimum criteria:
  • Storage warehouse:
    • The area must be appropriate to the type and quantity of medical equipment being stored.
    • Must ensure the space is cool, dry, clean and not near sources of pollution.
    • Must meet other storage requirements according to instructions for use.
  • Means of transportation: Must be suitable for the type of medical equipment the facility is delivering.
  • If there is no warehouse or storage facilities, the facility needs to sign a contract with a qualified unit to ensure the preservation and transportation of medical equipment.

For establishments that purchase and sell equipment containing narcotics and precursors, the following conditions must be met:

  1. The person in charge of the expertise must have a university degree in medical equipment, medicine, pharmacy, pharmaceutical chemistry or biology.
  2. It is necessary to have a storage warehouse that meets the provisions of Article 7 of Decree No. 80/2001/ND-CP dated November 5, 2001, guiding the control of domestic drug-related activities.
  3. There must be a system to monitor and manage the import, export and inventory processes for equipment containing narcotics and precursors.
Business conditions
Business conditions

Procedures for establishing a medical equipment trading company

The process of establishing a medical equipment business includes the following steps:

Step 1: Prepare documents to establish a company

Documents needed to prepare will depend on the specific type of business:

  1. Private enterprises (Article 21 of Decree 01/2021/ND-CP):
  • Application for business registration
  • Copy of legal documents of the business owner
  1. Partnership company (Article 22 of Decree 01/2021/ND-CP):
  • Application for business registration
  • Company charter
  • List of members
  • Copies of members’ legal documents;
  1. LLCs with two or more members and joint stock companies (Article 23 of Decree 01/2021/ND-CP):
  • Application for business registration
  • Company charter
  • List of founding members/shareholders
  • Copies of legal documents of the legal representative and members/shareholders
  1. One-member LLC (Article 24 of Decree 01/2021/ND-CP):
  • Application for business registration
  • Company charter
  • Copies of legal documents of the legal representative and company owner

Step 2: Submit documents to establish a company

According to Clause 1, Article 32 of Decree 01/2021/ND-CP, the application will be submitted to the Business Registration Office where the enterprise is headquartered.

Step 3: Get results

Pursuant to Clause 1, Article 33 of Decree 01/2021/ND-CP, the Business Registration Office will issue a Business Registration Certificate within 03 working days from receipt of valid documents.

Step 4: Post the announcement on the National Information Portal on business registration

According to Clause 2, Article 35 of Decree 01/2021/ND-CP, business registration information will be published on the National Business Registration Portal.

 Procedures for establishing a company
Procedures for establishing a company

Consulting and support services for establishing a medical equipment business in Long Phan

With a team of experts with many years of experience, Long Phan will provide the following consulting and support services:

  • Provide detailed information about legal regulations related to the establishment of medical equipment trading companies;
  • Support in preparing and completing business registration documents, including documents related to product certification and necessary licenses;
  • Consulting on facility appraisal and preparation, helping customers ensure production or purchasing facilities meet quality and safety standards;
  • Representing customers to carry out registration procedures with authorities, ensuring all processes are carried out accurately and quickly;
  • Monitor application processing progress;
  • Consulting solutions when registration documents are rejected;
  • Consulting on other related issues.

Establishing a medical equipment business is a complex process, requiring compliance with many legal regulations. Customers need to consider carefully and find out full information before deciding. For professional support in the process of establishing and operating a business, please contact Long Phan via hotline 0906735386. We are ready to advise and accompany customers throughout the business development process.