Indonesia Requires New Medical Device Specification Template for Product Registration

On March 10, 2026, Indonesia’s Ministry of Health issued Circular Letter No. FR.03.01/E.V/0395/2026, introducing a Standardized Medical Device Specification Template for medical device registrations. Where a Ministry-issued product-specific template is available, applicants must use the official Standardized Medical Device Specification Template.

The requirement applies to new registrations, renewals, and variation applications for medical devices in Indonesia. It aims to:

• improve alignment between product specifications and data recorded in the KFA system
• Standardize technical information across submissions
• Improve efficiency in the evaluation process

Standardized Specifications Become Mandatory for Regulatory Submissions

Information included in the Standardized Medical Device Specification Template (available here) must accurately reflect the device’s technical characteristics, correspond to the model or variant being registered, and remain consistent with the supporting dossier documentation.

The completed template must be uploaded in the medical device registration system as part of:

• New registration applications (Form C1)
• Renewal applications (Supporting Documents – Point 15)
• Variation applications (Supporting Documents – Point 15)

Where no official template exists for a specific product category, applicants may develop their own specification format. However, the document must align with applicable product standards and provide a complete technical description of the device.

Recommended Actions for Manufacturers and Registration Holders

Rather than treating the specification template as a final administrative requirement, companies should incorporate it into document preparation and review activities from the outset.

Recommended actions include:

• Confirm whether a Ministry-issued product-specific template is available and use it whenever required
• Develop an internal specification template aligned with applicable standards only where no official template exists
• Verify consistency between the specification template, KFA data, labels, IFUs, test reports, certificates, and other supporting documentation

A Clear Signal of Indonesia’s Focus on Data Integrity

The introduction of the standardized template reflects Indonesia’s broader emphasis on data integrity and regulatory system alignment across medical device registrations. By strengthening the connection between technical specifications, registration records, and KFA system data, the requirement makes inconsistencies more visible during regulatory review and places greater importance on maintaining consistent information throughout the submission dossier.

Contact Cisema to review your documentation, identify potential alignment gaps, and prepare compliant submissions under Indonesia’s updated requirements.

Further Information

Explore Cisema's services for medical device registration in Indonesia.

Reference

Circular Letter No. FR.03.01/E.V/0395/2026

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