Conditions for medical equipment trading establishments (Article 40)

Content

Detailed requirements

Personnel

At least 01 technical staff with a college degree or higher in engineering, medicine, pharmacy, chemistry, biology, or medical equipment engineering. Alternatively, another major is acceptable if relevant to the type of medical equipment being traded.

Storage warehouse

- Adequate space suitable for the types and quantities of medical equipment.

- Well-ventilated, dry, clean, and not located near sources of pollution.

- Meets other storage requirements as specified in the equipment’s instructions for use.

Transportation means

Appropriate for the type of medical equipment being traded.

If the establishment does not have its own warehouse or transportation, it must have a contract with a qualified facility to ensure storage and transportation.

Trading in medical equipment containing narcotic substances and precursors

- The person in charge must hold a university degree or higher in medical equipment engineering, medicine, pharmacy, pharmaceutical chemistry, or biology.

- Storage warehouse must comply with Article 7 of Decree No. 80/2001/ND-CP.

- A system must be in place to monitor and manage inventory (import, export, stock).

2. Dossier and procedures for declaration of eligibility to trade (Article 41)

Content

Detailed requirements

Declaration dossier

01 set, including:

1. Written declaration of eligibility for trading medical equipment.

2. Personnel list.

3. Documents proving compliance of the storage warehouse and transportation means.

4. Documents proving the inventory management system for medical equipment containing narcotics and precursors.

Procedures

- The establishment submits the dossier to the Department of Health where the trading location is based.

- The Department of Health publishes the dossier and declaration information on the medical equipment management portal.

- During operation, if there are any changes in the declared information, the establishment must notify and update the dossier within 03 working days from the date of change.

3. Cases exempted from conditions and declaration (Article 42)

Content

Detailed requirements

Exempted from conditions & declaration

Medical equipment of classes B, C, D included in the list issued by the Minister of Health may be traded as ordinary goods. They are not subject to the conditions in Article 40 and not required to declare under Article 41.

Still required to comply

Conditions on storage, preservation, and transportation as specified by the equipment owner.