Medical equipment are all kinds of equipment, tools, materials, implants, reagedies and in vitro standard materials, software that meets the conditions of diagnosis, prevention, monitoring, treatment … According to the regulations of the Ministry of Health, medical equipment is divided into 02 groups:
– Group 1 includes medical equipment of type A – medical equipment with a low risk level
– Group 2 includes medical equipment of groups B, C, D
However, regardless of the group, the medical equipment production facility must meet the following conditions:
2.1. Eligibility for receipt of declaration of eligibility for medical equipment production for enterprises
In order to operate the medical equipment industry, customers first need to set up a business.
In case the customer has had a previous enterprise, the company must be registered to operate the medical equipment manufacturing industry.
In case the customer already has a company, however, the equipment factory is achieved differently from the head office of the company, the enterprise needs to establish a branch or business location at the address where the factory is located.
2.2. Eligibility for receipt of declaration of eligibility for medical equipment production for manufacturing establishments
– There are locations and area of production plants in accordance with the requirements of the type of medical equipment.
– Production facilities must be certified iso 13485 quality standard
– There is a system of production subdivisions
– Having equipment and production process, quality inspection in accordance with the requirements of the type of medical equipment that the production facility produces.
– The museum warehouse meets the preservation requirements of the equipment according to the instructions for use.
– Facilities that meet fire protection and environmental conditions
– Having means of transporting medical equipment from the production facility to the place of delivery in accordance with the type of medical equipment that the production facility produces.
2.3. Eligibility for medical equipment production vouchers for personnel
a. Conditions of the person in charge of expertise:
The person in charge of expertise with a degree from a technical college of medical equipment or higher or a degree from a university majoring in engineering or majoring in medicine or pharmacy or higher. For medical equipment manufacturing establishments containing narcotics and precursors, the person in charge of expertise must have a university degree in medical equipment, medicine, pharmacy, chemistry or biology.
– Have a direct working time on medical equipment techniques at medical equipment establishments for 24 months or more.
– Working full-time at the production facility.
b. Staff conditions
There are staffs who meet the production requirements for the type of medical equipment that the facility produces.
Manufacturing medical equipment