Inside Bach Mai Hospital, the largest COVID-19 outbreak epicenter in Viet Nam, during the lockdown period in March-April 2020. Photo: Nguyen Khanh, Tuoi Tre newspaper

According to Resolution 60/NQ-CP dated 29 April 2020 by the Government and Document 3255/VPCP-KGVX dated 24 April 2020 by the Prime Minister Nguyen Xuan Phuc, the Ministry of Health was assigned to instruct enterprises manufacturing medical masks and medical equipment to enhance management and ensure quality of masks, medical equipment and test kits to respond to COVID-19 domestically and for export. The Ministry of Health (Department of Medical Equipment and Work) collaborated with the Directorate for Standards, Metrology and Quality – Ministry of Science and Technology, Viet Nam Certification Center (QUACERT) and UNDP to organise the workshop: “Enhancing quality and production capacity of PPE and supporting the export of PPE to respond to COVID-19”.

The workshop was organized to support enterprises that manufacture products to respond to COVID-19 including medical masks, gloves, and personal protection equipment to understand better the requirements of relevant standards and technical regulations for higher compliance, quality assurance and meeting requirements of domestic markets and expanding to the export markets.

At the workshop, Mr. Nguyen Minh Tuan, Director General of the Department of Medical Equipment and Construction, said that COVID-19 had significantly affected social activities and manufacturing of Viet Nam and other countries in the world, causing an abnormal increase in demand of PPE, particularly personal medical equipment including masks, gloves and PPE. To implement the Prime Minister’s direction and to support enterprises that manufacture medical equipment in Viet Nam, the Ministry of Health – Department of Medical Equipment and Construction has promulgated temporary regulations to instruct enterprises to meet fundamental requirements on standards and technical requirements to meet the domestic and international demand such as:

-          Decision 870/QD-BYT dated 12 March 2020, Temporary guidance for anti-bacterial cloth masks

-          Decision 1444/QD-BYT dated 29 March 2020, Temporary guidance on selection and usage of masks in prevention and response to COVID-19

-          Decision 1616/QD-BYT dated 08 April 2020, Temporary guidance on techniques, classification and selection of personal protection equipment for prevention and response to COVID-19

Manufacturing products meeting certain standards and technical regulations is a fundamental requirement of the world and of Viet Nam. The Government of Viet Nam always supports the efforts to promote sustainable production and to enhance capacity and productivity meeting the domestic demand and expanding to the export market. In terms of long-term development, the Ministry of Health will collaborate with the Ministry of Science and Technology to develop and promulgate standards and technical regulations for medical equipment, with the support of UNDP.

Representative of the Directorate for Standards, Metrology and Quality, Viet Nam Certification Center (QUACERT), Mr. Tran Quoc Dung – Deputy Director, highly appreciated the collaboration between the Ministry of Science and Technology and the Ministry of Health in providing information on standards and technical requirements for enterprises manufacturing medical equipment. The workshop supported enterprises to understand more about the requirements in order to manufacture products meeting standards and regulations of the domestic and overseas markets, contributing to socio-economic stability and development during COVID-19 and moving towards sustainable development. He also said the Directorate for Standards, Metrology and Quality, with its mandate, will collaborate with the Ministry of Health in development relevant standards and technical requirements on medical equipment.

Ms. Sitara Syed, Deputy Resident Representative of UNDP in Viet Nam, said “We are together with the Government of Viet Nam in supporting domestic enterprises in enhancing the quality and production capacity of medical masks and PPE to protect the frontline healthcare workers and public health. We see the crucial need to enhance the current standards, quality assurance and certification system to meet the domestic and export demand. Viet Nam can turn the COVID-19 challenge into an opportunity of becoming a leading country in manufacturing PPE for the world.”

Participants of the workshop exchanged and shared information to enhance quality and production capacity as well as find solutions to expand the manufacturing and export of medical equipment to respond to COVID-19.

The workshop had following presentations:

-          Mr. Doan Quang Minh – Department of Medical Equipment and Construction (Ministry of Health) had a presentation on general policy and regulation to support the manufacturing of medical equipment to respond to COVID-19.

-          Mr. Pham Quoc Binh – QUACERT, Directorate for Standards, Metrology and Quality, MOST had a presentation on the standards and technical regulations system on goods in general and on medical masks and gloves and personal protection equipment in particular; requirements for products/manufacturing process; requirements for certification.

-          Ms. Duong Thi Phong Hien, EUROFINS company– had a presentation on overview of production and export of PPE during COVID-19, opportunities for Viet Nam, requirements of USA and EU markets, issues on FDA and CE certificates in Viet Nam  

In addition, the workshop spent time for representatives of enterprises to share difficulties and advantages in manufacturing and export of medical equipment. The questions and answer section identified challenges and barriers in the production process and discussed on how to address these challenges and barriers. 

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