STAMEQ – UL online workshop on Medical Devices Standards

Post by: Biên tập viên ISMQ - Post date: Tuesday, Aug 3, 2021 | 18:07 - View count: 401

On August 2, the Directorate for Standards, Metrology and Quality (STAMEQ) and the American Association of Laboratories Underwriter Laboratory (UL) co-organized a Webinar on Standards for medical devicesfor the purpose of sharing, contributing knowledge and information on the development and application of equipment standards in the world and in Vietnam.

 Over the past two years, the Covid-19 pandemic has taken a huge loss to people and the world and there is currently no sign of stopping. The field of manufacturing and importing Medical devicesalso faces common difficulties but also unprecedented opportunities due to the increasing demand for medical equipment.

Recognize the importance of Medical devicesin the current context, the Directorate for Standards, Measure and Quality (STAMEQ) and the American Association of Laboratories – Underwriter Laboratory (UL) have co-organized a Standard Workshop for Medical devicesfor the purpose of sharing , contributing knowledge and information about building and applying equipment standards in the world and in Vietnam.

The workshop is within the framework of the signed cooperation agreement between STAMEQ and UL. The workshop was attended by more than 70 vietnamese delegates who are members of the relevant Technical Department, officials and experts of the Ministry of Health, GDVT and relevant ministries.

The speakers presented at the seminar were experienced experts from UL – USA and Technical Departments of Vietnam including Ms. Cao Thi Van Diep – Head of Technical Department TCVN/TC194, Chief of Office of Vietnam Medical devicesAssociation; Ms. Doan Thi Bich Nga, Main Engineer, Vietnam Institute of Quality Standards, Secretary of TCVN Technical Departments for Medical devicesand Ms. Chenchen Lee – Program Director/Department of Consumer, Health and Information Technology of UL.

The reports highlighted the situation of medical device manufacturing in Vietnam, highlighting the difficult situation of Vietnam’s medical device manufacturing industry in the context of most enterprises establishing new or converting to manufacturing Medical devices, especially masks in a very short time. Enterprises do not know the policies, legal corridors, procedures, certifications necessary in production and export and it is difficult to find reputable legal consultancy units to meet the standards …

The delegates were also updated to update the standardization situation in the field of Medical devicesin Vietnam today, thereby showing that with current TCVN, it has basically met the requirements in the quality management of Medical devicesin the current context.

Among them is the Set of TCVN 7303 (fully accepted IEC 60601) for medical electrical equipment – Basic safety requirements and essential features of specialized medical equipment. Some TCVN related to respiratory equipment and ventilators are also being urgently built and announced to serve the needs of medical examination and treatment in the context of the Covid-19 pandemic. However, up to now, the TCVN system with 260 standards is still quite modest and has not covered all the subjects in this field.

In particular, UL has sent an UL experienced expert in Medical devicestesting to give an overview of international standards for Medical devicesand testing requirements, including IEC 60601, devices within the scope of this standard…