Posted by In India, medical devices are strictly regulated under the Medical Device Rules, 2017, by the Central Drugs Standard Control Organization (CDSCO). When a device is approved, manufacturers and importers may seek modifications in licensing information over a period of time. These are called post-approval changes to medical devices, and they must meet regulatory procedures. Otherwise, the safety and performance of medical devices are at stake.
This post explains medical devices post-approval changes, differences between major and minor changes, and how to get approval from the CDSCO.
What Are Post-Approval Changes for Medical Devices in India
Post-approval changes for medical devices in India refer to any modifications in the following aspects:
- Device Design
- Material of Construction
- Intended Use
- Manufacturing Process
- Testing
- Labelling
- Packaging
Such changes are divided into major and minor changes. Major changes are those that require prior approval, and minor changes are those that require only notification. These post-approval changes determine the action that the manufacturer or importer must take before implementing the changes.
Types of Post-Approval Changes for Medical Devices
According to the Sixth Schedule of the Medical Device Rules, 2017, post-approval changes in medical devices fall into two categories:
1. Major Changes (Require CDSCO Prior Approval)
Major changes are significant as they impact the quality, safety, or performance of your device. You need approval from CDSCO before implementing the changes. List of major post-approval Changes are as follows:
1. Material of construction
2. Design which shall affect quality in respect of its specifications, indication for use; performance and stability of the medical device
3. Intended use or indication for use
4. Method of sterilization
5. Approved Shelf life
6. Name or address of:
(i) Domestic manufacturer or its manufacturing site
(ii) Overseas manufacturer or its manufacturing site (for import only)
(iii) Authorised agent (for import only)
7. label excluding change in font size, font type, color, label design
8. Manufacturing process, equipment or testing which shall affect quality of the device
9. Primary packaging material
2. Minor Changes (Require CDSCO Notification Only)
Minor changes impact the quality, safety, or performance of the device in a way that isn’t significant. So, they need just the CDSCO notification. But it is important to notify the CDSCO within the stipulated timelines of the change. Examples of minor changes include:
- Design which shall not affect quality in respect of its specifications, indication for use, performance and stability of the medical device;
- Minor Changes in the manufacturing process, equipment, or testing which shall not affect quality of the device;
- Packaging specifications excluding primary packaging material
CDSCO Post Approval Changes in Medical Devices – What Is the Approval Process
The approval process depends on the type of the change, if it is major or minor:
Approval Process for Major Changes
- Application Submission: Manufacturers/ Importers must submit a request to the CDSCO for approval.
- CDSCO Review: The CDSCO reviews the request and either grants approval or raises objections.
- Approval: After successful examination of documents, authority grant the approval for major changes.
Approval Process for Minor Changes
- Notification: Inform the CDSCO within 30 days of making the change.
- Approval: Only notification is required.
Tips to Stay Compliant
Here are some effective ways to stay compliant with the medical devices post-approval changes process:
- Categorise changes into major/ and minor categories accurately.
- Have clear documentation for all the major and minor changes.
- Comply the official timelines for notifications related to your change and follow them diligently.
- Communicate with our regulatory experts for guidance that will help you avoid compliance issues.
Pre-requisites for Doing Post-Approval Changes in Medical Devices
Before you make the changes and ask for approval, you must have the following ready:
- Manufacturers/ Importers must have valid manufacturing/ Import license. It means Form MD-5/Form MD-6 for Class A/B or Form MD-9/ Form MD-10 for Class C/D devices. Importers must hold a valid import license in Form MD-15.
- Manufacturers/ Importers must have updated Device Master File (DMF) or Plant Master file (PMF) as applicable. It should be in line with the proposed change.
How Can Dueran Consultant Help?
As a leader in offering regulatory guidance and support, we help you to understand whether it is major or minor changes, further preparation of technical documentation and managing submissions through the CDSCO MD SUGAM portal.
We also keep a steady communication with the CDSCO officials on your behalf, track timelines for approvals or notifications, and provide customised compliance advice. You can seek our assistance in filing of major or minor Post approval changes to the existing manufacturing or Import licenses by contacting us anytime or schedule a free consultation.
