CE certification for Medical Devices, Medical Masks, Medical Gloves according to directive 93/42/EEC Medical devices to be eligible for export to the EU market. CE certification classification guidelines for medical devices.

CE marking certificate compliance with the EU directive
CE certification for Medical Devices, Medical Masks according to directive 93/42/EEC Medical devices - Guidelines for classification of medical devices
The Medical Devices Directive aims to harmonize the laws relating to medical devices in the European Union. The MD Directive is a 'New Approach' Directive and therefore, for a manufacturer to place a medical device legally on the European market, the requirements of the MD Directive must be met.
Medical device manufacturers need to identify their products according to the classification below, before proceeding with the procedures to apply for CE certification under directive 93/42/EEC for medical devices.
MD 0101 - Non-functioning device for anesthesia, emergency and intensive care.
MD 0102 - Inactive device for injection, transfusion, blood transfusion and dialysis.
MD 0106 - Instrument not working.
MD 0108 - Non-functioning medical devices for sterilization, cleaning, washing.
MD 0300 - Wound care equipment.
MD 0301 - Wound dressings and dressings.
MD 1100 - General operating medical equipment.
MD 1101 - Devices for extracorporeal circulation, infusion and coagulation.
MD 1103 - Stimulating or inhibitory devices.
MD 1104 - Active surgical equipment.
MD 1107 - Active devices for sterilization and disinfection.
MD 1108 - Rehabilitation devices and active prostheses.
MD 1109 - Active device for patient positioning and transport.
MD 1111 - Software.
MD 1300 - Monitoring equipment.
MD 1301 - Instrument for monitoring non-critical physiological parameters.
MD 1302 - Monitor for important physiological parameters.
MD 1400 - Radiation and heat therapy equipment.
MD 1402 - Equipment using non-ionizing radiation. 

Figure 1: CE marking expert assessor VINTECOM International at the production site
VINTECOM International was officially appointed by the EU directive notification agency to participate in supporting medical equipment manufacturers in Vietnam in training, conformity assessment and consulting and guiding activities for businesses. qualified for CE certification for Medical Devices as above classification in accordance with the order and procedures specified in EU directive 93/42/EEC for medical devices.

📶📶📶 Contact us to register for CE mark certification compliance with the EU directive.

Customers, organizations and enterprises require The Medical Device Single Audit Program (MDSAP) or CE marking Certification services, please click on "Registration - Quotation" or on the right toolbar below the PC screen to receive a quotation for training, consulting and certification services.

📶📶📶 Further information, please contact us as below:

🌐  VINTECOM International Office in Ha Noi City: 16th Floor - Green Stars City, 234 Pham Van Dong, Bac Tu Liem District, Ha Noi City. Hotline 094-886-5288/ (024) 730-588-58

🌐  VINTECOM International Office in Ho Chi Minh City: Golden City House - 182 Ha Huy Giap, 12 District, Ho Chi Minh City. Hotline 0938-083-998/ (028) 7300-7588


Head Office: No. 5 Hoang Sam treet, Nghia Do, Cau Giay district, Ha noi City


Address:   16th Floor - Green Stars City

234 Pham Van Dong Street, Bac Tu Liem District, Ha noi City

Tel       :    (024) 730.588.58/ (024) 730.333.86

Hotline:     094 886 5288

Skype:       kd.vintecom 

Email :       office-hn@vintecom.com.vn

Web :         www.vintecom.com.vn


Address : Golden City House 

182 Ha Huy Giap Street, District 12, Ho Chi Minh City

Contact:   Ms. Pham Thu Ha

Tel:          (028) 7300 7588  

Hotline:   0938 083 998

Email :    office-hcm@vintecom.com.vn

Web :      www.vintecom.com.vn

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