Regulations you need to know when medical equipment business

Medical equipment business brings great opportunities as the demand for health care increases. However, this field requires businesses to strictly comply with quality, safety, and legal regulations to ensure products meet medical standards. Understanding these regulations not only helps businesses avoid risks but also builds reputation in the industry, enhances competitiveness and best serves customers.

General Regulations on Medical Equipment Business

According to Decree 98/2021/ND-CP, medical equipment businesses need to meet three basic requirements. Specifically:

Personnel requirements:

• Enterprises need to have at least 01 technical employee with a college degree or higher, specialized in the type of medical equipment the enterprise is trading;
• The person in charge of the profession must have a university degree, with a major related to medical equipment, ensuring the ability to monitor and control quality throughout the production, preservation and distribution of the product.

Facility requirements:

• Medical equipment storage warehouses must meet hygiene and safety standards as prescribed, ensuring that the equipment is not damaged or lost quality during storage;
• The means of transportation must be suitable for the nature of the medical device, ensuring safety during the transportation process from the warehouse to distribution points or customers;
• The quality management system must comply with national or international standards on quality management, including strict quality control processes at each stage from import, production, storage to distribution, to ensure the quality of medical equipment always meets standards and is safe for users.

Regulations related to manufacturing and importing medical devices

Decree 98/2021/ND-CP provides detailed regulations on the process of manufacturing and importing medical equipment. Businesses need to comply with national and international technical standards. The quality management system must meet ISO 13485 standards.

Conditions for quality management of medical equipment manufacturing facilities:

1. Meets ISO 13485 quality management system standards.
2. For facilities manufacturing medical equipment containing narcotics and precursors, in addition to meeting the conditions specified in Clause 1 of this Article, the following additional requirements must be met:

• There is a system to monitor and manage the process of exporting, importing, storing, and using raw materials that are drugs and precursors, the process of exporting, importing, and storing medical equipment, and raw materials containing drugs and precursors;
• Medical equipment, raw materials containing narcotics and precursors are stored in a separate area in a separate warehouse or warehouse, which must ensure safety.

Organizations and individuals importing medical equipment that already has a circulation number must meet the following conditions:

• Be the owner of the circulation number or have authorization from the circulation number owner. The owner of the circulation number, when authorizing an import facility to import medical equipment, must simultaneously send that authorization document to the agency issuing the circulation number and the customs authority;
• Have warehouses and transportation vehicles that meet regulatory requirements or have a contract with a facility with sufficient capacity to preserve and transport medical equipment;
• There is a storage warehouse and a monitoring and management system for the export, import and inventory of medical equipment containing narcotics and precursors that meet regulatory requirements.

CSPL: Article 8, Article 47 of Decree 98/2021/ND-CP.

Requirements for Medical Device Quality

The quality of medical equipment must meet standards prescribed by the Ministry of Health. The product needs to have complete documents proving safety and effectiveness. The periodic inspection process must be strictly implemented.

• Already have a circulation number or import license as prescribed in this Decree, except for the cases specified in Clause 8, Article 3 and Article 24 of Decree 98/2021/ND-CP;
• Have a label with full information according to current regulations of law on goods labels;
• Have instructions for use of the medical device in Vietnamese;
• There is information on the warranty facility, conditions and warranty period, except for single-use medical devices as prescribed by the medical device owner or there is documentation proving that there is no warranty.

Some notes when importing and exporting medical equipment

Import and export activities of medical equipment must comply with the regulations of the Ministry of Health and Customs. Businesses need to prepare complete legal documents. The customs clearance process must be strictly followed. Some notes to keep in mind include:

• License and certification: Businesses need a medical device business license and quality certification (CE, FDA, etc.) depending on the export market.
• Customs procedures: Need to fully declare product information, origin and documents proving quality. Imported equipment must pass inspection by the Ministry of Health.
• Distribution and preservation system: Build a medical equipment preservation system according to standards, especially products that require strict storage conditions.
• Ensuring product quality: Check equipment quality before exporting and comply with quality inspection procedures when importing.
• Labels and instructions for use: Equipment must have clear labels, information on origin, instructions for use and safety warnings, translated into the language of the importing country.
• Monitoring and maintenance: Enterprises need to have a system to monitor and maintain equipment after import, ensuring that the equipment always operates safely.

Support and advice on medical equipment business conditions and procedures

With a team of experts with many years of experience at Long Phan, we provide professional consulting services on medical equipment business conditions. Services provided by Long Phan include:

• Providing full service support for medical equipment business procedures;
• In-depth consulting on business conditions for businesses;
• Guidance on completing dossier components, representing customers to carry out procedures with competent state agencies;
• Support to review and complete documents for implementing medical equipment business procedures;
• Accompany customers in solving problems that arise during operations.

Medical equipment business is a field that requires strict compliance with regulations to ensure user safety and product quality. Businesses that want to operate in this field need to fully meet the business license conditions. If you need in-depth advice, please contact Long Phan immediately via the hotline: 0906735386 for detailed advice on medical equipment business conditions and processes.