For medical device companies preparing to enter Indonesia, Research Use Only (RUO) positioning may offer a way to begin local research activities before commercial registration is complete. It can support early collaboration, product testing, and market preparation, but it is not an alternative to commercial registration.
1. What Is Research Use Only?
Research Use Only medical devices are intended exclusively for research purposes, such as pre-commercial research, performance testing, non clinical validation, and feasibility studies. They are not intended for routine diagnosis, treatment, monitoring, or commercial healthcare use.
A device designated for research use should carry the label “For Research Use Only” and must be used within the scope of its stated purpose.
2. How RUO Can Support Early Market Preparation?
RUO devices may allow companies to work with local research institutions through performance studies, feasibility assessments, and non clinical validation. These activities can help companies evaluate product suitability, understand local research requirements, and establish relationships with potential research partners.
For companies planning to enter Indonesia next year, this early engagement may provide useful preparation while the commercial registration process is underway.
3. What Companies Need to Consider?
RUO positioning does not permit commercial distribution or routine clinical use. Using a research only designation for commercial purposes may create regulatory and compliance risks.
Depending on the product and study design, companies may also need a local research partner and approval for the relevant research protocol from the Ministry of Health or another authorized party, where applicable.
Before starting, companies should confirm the product’s intended use, prepare consistent labeling and documentation, review the applicable research requirements, and plan the commercial registration pathway.
RUO positioning can support early research engagement in the country when used appropriately. Mursmedic can help companies assess the relevant regulatory requirements and develop a market entry strategy for future commercialization
Connect with our team to discuss your product, research plans, and the regulatory pathway for future market entry
Email: marketing@mursmedic.com
Phone: +62 811-1929-2933
Website: www.mursmedic.com
LinkedIn: PT Mursmedic
