According to legal regulations, the implementation of ISO 13485 is one of the mandatory requirements for enterprises engaged in the manufacturing and trading of medical devices.

Increasing Demand for Certification

ISSQ Institute is a certification body licensed by the Directorate for Standards, Metrology and Quality under the Ministry of Science and Technology. Currently, ISSQ Institute provides certification services in the field of science and technology, including ISO 13485:2016 certification.

Since new regulations on certification of Medical Device Quality Management Systems were introduced, the demand for ISO 13485 certification at ISSQ Institute has been increasing significantly. In just two years, from early 2020 to November 2021, ISSQ Institute conducted assessments and granted certificates to 448 organizations operating in the medical device manufacturing and trading sector.

ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes (collectively referred to as the Medical Device Quality Management System) was issued by ISO (International Organization for Standardization) in 2003. On March 1, 2016, ISO 13485:2016 was published to replace the previous version ISO 13485:2003.

ISO 13485:2016 is a standard that specifies requirements for quality management systems applicable to organizations involved in the production and trading of medical devices and equipment. ISO 13485 is an important condition for ensuring the capability to supply products that meet customer requirements and legal regulations.

This standard specifies requirements for a Quality Management System (QMS) when an organization needs to demonstrate its ability to consistently provide medical devices and related services that meet customer requirements and applicable regulatory requirements.

ISO 13485 can be applied to organizations and enterprises of all sizes and types that are involved in one or more stages of the medical device life cycle, including design and development, production, storage and distribution, installation, servicing of medical devices, as well as the design and development or provision of related activities (e.g., technical support).

Compliance with Legal Regulations

According to Article 68 of Government Decree No. 36/2016/ND-CP dated May 15, 2016 on Medical Device Management, effective from July 1, 2016:

“Medical device manufacturing facilities that were operating before the effective date of this Decree may continue their production activities but must complete the declaration of eligibility for manufacturing before July 1, 2017. Regarding quality management system requirements: medical device manufacturing facilities must complete the implementation of ISO 9001 quality management system before January 1, 2018 and ISO 13485 quality management system before January 1, 2020.”

There was a transition period of three years for manufacturers and other organizations to convert from the old version to the new version. That means by February 28, 2019, when ISO 13485:2003 expired, upgrading to the new version ISO 13485:2016 from ISO 13485:2003 had to be completed no later than January 1, 2020. Therefore, January 1, 2020 was the final deadline for enterprises to develop and obtain certification in accordance with ISO 13485:2016 as required by law.

Benefits of ISO 13485 Standard

• Meeting legal requirements (Decree 36/2016/ND-CP).

• Helping leadership manage operations effectively and promote better working discipline.

• Enhancing corporate image and credibility with customers through better control and provision of high-quality products and services.

• Providing products and services based on a systematic approach to continuously satisfy customers.

• Managing business processes in an integrated manner, focusing not only on individual procedures but also on their interactions.

• Helping enterprises manage and obtain evidence regarding the operation of the entire process, thereby enabling better decision-making and optimal allocation of resources.

• Employees become proactive in handling tasks by clearly identifying their responsibilities and authorities, enabling them to make decisions and actively improve the processes they frequently use.

ISO 13485 Certification by ISSQ Institute

In the medical device industry, “quality” and “safety” are inseparable requirements. The requirements specified in ISO 13485:2016 must be implemented throughout all stages of the medical device life cycle, including post-production stages such as delivery, servicing, and maintenance.

To meet the minimum legal requirements under Government Decree No. 36/2016/ND-CP dated May 15, 2016, ISO 13485:2016 has become increasingly essential for organizations and enterprises operating in the medical device sector.

At ISSQ Institute, customers will receive the best service information. Moreover, with a reliable and experienced team of experts, customers will be thoroughly guided and supported throughout the certification process in a clear and cost-effective manner.

ISSQ Institute is always ready to accompany companies during the period of integration and development.

Please contact us via hotline: +84 981851111 | +84 2422661111 or email: vienchatluong@issq.org.vn | tcvn@issq.org.vn

Posted date: November 24, 2021