Consultancy on declaration of eligibility for medical equipment production

According to the current law, establishments/enterprises may only produce medical equipment after they have been issued a receipt of dossiers of production eligibility by the Department of Health.

Legal basis:

– Decree No. 36/2016/ND-CP on management of medical equipment

– Decree No. 169/2018/ND-CP amending and supplementing a number of provisions in Decree No. 36/2016/ND-CP on management of medical equipment

– Consolidated Document No. 01/VBHN-BYT of the Ministry of Health: Decree on management of medical equipment, date of promulgation: 16/03/2020

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

– Certificate of business registration

– ISO 13485:2016 quality management system certificate (with the scope of certification corresponding to production activities)

– Confirmation of the working time of the organization operating medical equipment confirming to the personnel responsible for production at the facility (minimum confirmation period of 24 months)

– Diplomas and training certificates of professional curators

– Decision on appointment of the person in charge of expertise at the production facility

– ID card/CCCD/Passport of the person responsible for production at the facility

– List of equipment at the factory

– List of personnel at the factory

– Production process and product quality management

– Test contract (if the facility does not have the capacity to check the quality to check the medical equipment that the production facility produces), the warehouse lease contract (if the facility does not have a storage warehouse), the transport contract (if the vehicle is a rental facility)

Strep 1: Prepare the application and submit the application to the Department of Health where the factory is located at the online page of the Ministry of Health: https://dmec.moh.gov.vn/.

Step 2: The expert receives the dossier, considers then issued an additional amendment (if the application is not valid), licensed (if the application is valid).

Step 3: After being licensed, the Department of Health will publicize the information of the facility about the eligibility to produce medical equipment.

NOTE:

All documents for the production facility, although submitted online, also need to prepare the full dossier at the facility. Because after issuing the License, the Department of Health can set up a post-inspection team at any time.

5.1. Services of GMP Groups

For start-ups in the medical field, the implementation of administrative procedures is often very difficult. GMP Groups provides customers with services to announce eligibility for medical equipment production including the following contents:

– Free consultation on related issues before proceeding with the procedure.

– Advising on preparation of dossiers and conditions to meet regulations on the production of medical equipment.

– Drafting dossiers, editing dossiers and carrying out procedures at competent state agencies on behalf of customers.

– Carry out the procedures for publication at the Department of Health, monitor records, respond to dossiers if requested under your authorization.

– Get the results and hand them over to the customer.

– Assist in solving any problems that arise during the implementation process.

5.2. Why should GMP Groups be the consulting unit that announces eligibility to produce medical equipment?

We have made a lot of applications for vouchers to qualify for the production of medical equipment for customers. We are aware of the provisions in the decrees and documents on the management of medical equipment as well as the order of application for receipt slips to ensure the quickest, most complete and accurate records.

GMP GROUPS – NO. 1 SERVICE ANNOUNCES ELIGIBILITY TO MANUFACTURE MEDICAL EQUIPMENT IN VIETNAM. 

GMP Groups Joint Stock Company

Head office: No 273 Hoa Ban, Ecoriver Eco-Investor, Hai Tan Ward, Hai Duong City, Hai Duong Province

Hotline: 0945.255.457 – Email: info@gmpgroups.com.vn – Web: gmpgroups.com.vn