VINTECOM International delivers MDR training and technical file consulting under Regulation (EU) 2017/745 for Merap Group toward CE Marking for the EU market.

Training & Consulting Program on CE Marking Product Technical File under Regulation (EU) 2017/745 (MDR)
As regulations governing medical devices in Europe become increasingly stringent, full compliance with the legal requirements of the European Union has become a prerequisite for Vietnamese products to access international markets. Recently, VINTECOM International conducted an advanced training program, consulting on Product Technical File development, and management system assessment for Merap Group—one of the leading pharmaceutical corporations in Vietnam and the owner of several reputable brands in the market, including Osla.
The program was implemented to support the enterprise in standardizing its management system and product technical documentation in accordance with Regulation (EU) 2017/745. This serves as a foundation for products to meet the evaluation requirements of EU Notified Bodies (NB-EU) and to obtain CE Marking, enabling eligible products to be exported to the European market.
Training and System Standardization under MDR 2017/745
Within the framework of the program, the expert team from VINTECOM International conducted intensive training sessions and practical guidance for the technical, quality management, and research & development teams of Merap Group.
The training content focused on helping the manufacturer clearly understand and correctly implement the core requirements of MDR, including:
+ Overview of the EU medical device regulatory framework
+ Medical device classification under MDR
+ Quality management system requirements for manufacturers
+ Development of product technical documentation according to Annex II and Annex III
+ Risk management in accordance with international standards
+ Clinical Evaluation (CER)
+ Post-Market Surveillance (PMS) and Vigilance
For products classified as non-invasive devices that come into contact with mucous membranes, VINTECOM experts guided the enterprise in determining the correct classification under Rule 5 – Annex VIII, where devices with transient mucosal contact are classified as Class I.
Consulting on Product Technical File Development According to EU Standards
One of the key components of the program was the development and completion of the Product Technical File in accordance with the MDR standard structure.
The VINTECOM expert team guided the enterprise in establishing the critical elements of the Technical File, including:
+ Device description and Intended Purpose
+ Device classification under MDR and justification of classification
+ Design documentation and manufacturing process
+ General Safety and Performance Requirements (GSPR) Checklist
+ Product risk management documentation
+ Testing data and biological evaluation
+ Clinical Evaluation Report (CER)
+ Product labeling and Instructions for Use (IFU)
+ Post-Market Surveillance Plan
Preparing a complete technical documentation package is a critical requirement for products to be evaluated by EU Notified Bodies or to perform self-declaration of conformity for Class I devices in accordance with MDR regulations.
System Assessment and Readiness for CE Marking
In parallel with training and technical documentation consulting, VINTECOM International also conducted an assessment of the company’s quality management system, focusing on key elements such as:
+ Product design control
+ Supplier and raw material control
+ Production control and batch traceability
+ Change control procedures
+ Complaint handling and medical device vigilance
+ Post-market surveillance of products

Figure 1: Nasal hygiene solution – Deep Sea Water XISAT developed by Merap Group for the EU market in accordance with MDR 2017/745.
This assessment process enabled the enterprise to identify areas requiring improvement within its management system to ensure full compliance with MDR requirements prior to CE Marking declaration.
Supporting Vietnamese Enterprises in Accessing the EU Market
With extensive experience in consulting international standards for enterprises within the global supply chain, VINTECOM International continues to demonstrate its capability in supporting Vietnamese companies in developing technical systems and documentation that comply with the strict regulatory requirements of the European Union market.
The collaboration program with Merap Group represents an important milestone that helps the enterprise:
+ Standardize its management system according to MDR requirements
+ Complete product technical documentation in accordance with EU standards
+ Prepare for evaluation by EU Notified Bodies
+ Enhance access to the European market through CE Marking
Through comprehensive training and consulting activities, VINTECOM International continues to accompany Vietnamese enterprises in strengthening their technical capabilities, complying with international standards, and expanding into global markets.
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☎ VINTECOM International Office in Ha Noi City: 16th Floor - Green Stars City, 234 Pham Van Dong Street, Phu Dien Ward, Hanoi City. Hotline 094-886-5288/ (024) 730-588-58

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