The new Exempt Resolution officially approves the Recommended Guide for Good Manufacturing Practices for Medical Devices, including In Vitro Diagnostic Medical Devices (IVDMD), prepared by the Chilean Institute of Public Health (ISP) through its National Medical Device Agency.

This guide seeks to establish a technical framework to ensure that medical device manufacturing processes meet appropriate quality, safety, and performance standards, in accordance with current national and international regulations.

This guide establishes the need for manufacturers to have a formally documented, implemented, and maintained quality management system (QMS). This system must be compatible with the NCh-ISO 13485:2017 standard, approved by the National Institute of Standardization (INN), and covers processes such as design, development, manufacturing, storage, distribution, sterilization, labeling, and kitting.

WHOM DOES IT IMPACT?

The direct impact is on manufacturers, importers, companies that package, sterilize, label, and distribute medical devices and IVDs in Chile, healthcare providers, and clinical laboratories.

ONCLUSION:

This guide represents an important technical advance in Chilean health regulation on medical devices.

Although its adoption is not legally binding as a law or regulation, its approval by the ISP makes it an essential reference instrument for certification and oversight processes, and non-compliance could generate indirect consequences during inspections or authorization processes. By establishing clear, technical guidelines aligned with international standards, the guide seeks to strengthen confidence in the quality of medical products offered in the country.