Changes to medical devices and in vitro diagnostic devices with existing distribution permits can be classified as either significant or insignificant. This classification depends on their impact on safety, quality, and performance.
To report these changes, companies may submit a new distribution permit, request a change to the existing permit, or notify the Minister of Health and the Director General of Pharmaceuticals and Medical Devices. This must be done in accordance with applicable regulations. Specifically, if changes do not affect safety, quality, or performance, companies should submit a request for a change in the distribution permit. In contrast, if changes impact product labeling, they should be reported as a notification to the Director General.
Types of Changes to Medical Devices and In Vitro Diagnostic Medical Devices
1. Changes to the production process, facilities and/or quality management system including quality control.
| Changes to Production Process, Facilities and/or Quality Management System | ||
| Examples | Category | Registration Type |
| Changes or additions to the manufacturer’s address and changes to the scope for registered devices. | Significant | NewApplication |
| Changes to postal codes, corrections to typos and improvements to quality management system certificates and their attachments. | Not Significant | Request for changes |
2. Changes to the design of a medical device or in vitro diagnostic medical device
| Design Changes for Medical Devices and In Vitro Diagnostic Medical Devices | ||
| Examples | Category | Registration Type |
| Changes in risk analysis results during design validation that lead to safety issues, such as changing from direct current (DC) to alternating current (AC) or vice versa. | Significant | NewApplication |
| Change in the color of reagent caps | Not Significant | Request for changes |
3. Changes to the sterilization facility, processes and/or quality management system of the sterilization facility
| Changes to Sterilization Facilities, Processes and/or Quality Management Systems | ||
| Examples | Category | Registration Type |
| Change from ethylene oxide gas sterilization to gamma radiation | Significant | NewApplication |
| Change from using air (80% nitrogen and 20% oxygen) to pure nitrogen in the aeration process to prevent gas mixture explosions | Not Significant | Documented in the quality management system (sterilization validation documents) |
4. Software changes
| Software Changes | ||
| Examples | Category | Registration Type |
| Changes to software that result in critical modifications to the laser processing for eye therapy | Significant | NewApplication |
| Changes to software to disable specific functions that do not interact with other functions | Not Significant | Documented in the quality management system |
5. Changes in raw materials for medical devices
| Changes in Medical Device Raw Materials | ||
| Examples | Category | Registration Type |
| Change in gelatin source from pork to beef | Significant | NewApplication |
| Change in supplier or vendor of materials, provided that the materials meet the specifications of the manufacturer as previously reviewed. | Not Significant | Documented in the quality management system |
6. Changes to Raw Materials for In Vitro Diagnostic Devices
| Raw Material Changes for In Vitro Diagnostic Devices | ||
| Examples | Category | Registration Type |
| Changes in reagent formulation in test kits (e.g., buffer concentration, addition of preservatives) | Significant | NewApplication |
| Changes in non-critical raw materials, such as switching magnesium stearate from animal to plant sources in reagents for in vitro diagnostic devices, without changes in product performance specifications. | Not Significant | Documented in the quality management system |
7. Changes to Labeling
| Labeling Changes for Medical Devices | ||
| Examples | Category | Registration Type |
| All changes to medical device labeling, including additions, deletions, and/or revisions to warnings, cautions, and/or contraindications that do not arise from safety and/or performance issues | Significant | NewApplication |
| Labeling changes due to typographical errors: | Not Significant | Request for changes |
For more detailed information, please refer to the Guidelines for the Management of Changes in Medical Device and In Vitro Diagnostic Device Registration (https://farmalkes.kemkes.go.id/unduh/pedoman-manajemen-perubahan-izin-edar-alat-kesehatan-dan-alat-kesehatan-diagnostik-in-vitro/)
