MDR 2017 Testing Fees: What G.S.R. 743(E) Means for Medical Device Manufacturers

India's medical device regulatory framework has received an important update with the Medical Devices (Second Amendment) Rules, 2026, notified under G.S.R. 743(E).

The amendment to the Medical Devices Rules, 2017 (MDR 2017) introduces a dedicated fee structure for specified medical device tests and evaluations through a new Ninth Schedule. The amendment also links the prescribed testing fees to Rule 19 and Rule 69, creating a more structured framework for testing and evaluation of medical devices.

The notification was published in the Official Gazette on 19 August 2026.

This development is particularly relevant for medical device manufacturers, importers, applicants for regulatory approvals, medical device testing laboratories, and regulatory affairs professionals who need to plan testing activities and associated compliance costs.

What is G.S.R. 743(E)?

G.S.R. 743(E) is the notification titled the Medical Devices (Second Amendment) Rules, 2026.

It amends the Medical Devices Rules, 2017 and, among other changes, introduces the Ninth Schedule – “Fee for test or evaluation.” The Ninth Schedule is referenced in Rules 19 and 69.

The amendment follows the earlier draft proposal issued in April 2026, which proposed standardized fees for medical device testing and evaluation. The final notification was subsequently issued after consideration of objections and suggestions to the draft.

What has changed under MDR 2017?

The key regulatory change is the introduction of a defined fee schedule for specified tests and evaluations.

Previously, the MDR framework did not contain the same dedicated Ninth Schedule structure for these testing fees. The amendment now establishes prescribed costs for several categories of medical device testing.

The amendment also inserts a new provision into Rule 19, stating that the fees for test or evaluation are those specified in the Ninth Schedule. Rule 69 is also amended to connect applications made under that provision with the applicable fee specified in the Ninth Schedule.

New Medical Device Testing Fees under the Ninth Schedule

The fee structure includes the following categories:

These fee categories were set out in the Ninth Schedule proposed in the April 2026 draft and are reported as part of the August 2026 amendment introducing the schedule.

Why is the Ninth Schedule important?

The Ninth Schedule creates greater visibility around the cost of specified regulatory testing.

For manufacturers, this can make it easier to:

• estimate regulatory testing expenditure;
• prepare regulatory budgets;
• plan product development and verification activities;
• assess the cost of testing for new devices;
• coordinate testing with registered medical device testing laboratories; and
• incorporate testing expenses into regulatory and commercial planning.

It also provides a common statutory reference point for the specified tests rather than leaving the fee structure entirely outside the MDR framework.

Which MDR 2017 Rules are affected?

Rule 19 – Test or evaluation of medical devices

The amendment connects the fees for testing and evaluation with the Ninth Schedule.

The newly inserted provision provides that the fees for test or evaluation shall be those specified in the Ninth Schedule.

This is significant because Rule 19 deals with testing/evaluation of medical devices through the regulatory testing framework.

Rule 69 – Application for registration of medical device testing laboratory

The amendment also modifies Rule 69 so that the relevant application in Form MD-33 is accompanied by the fee specified in the Ninth Schedule.

Therefore, the amendment is not simply a standalone price list. It integrates the fee schedule into the operative provisions of MDR 2017.

What about tests that are not listed?

An important feature of the proposed Ninth Schedule is the treatment of tests or evaluations that are not specifically listed.

For tests not specified in the table, the charges are to be determined by the Director or Medical Device Testing Officer of the relevant laboratory/institute, as applicable.

This provides flexibility because medical device testing requirements can vary significantly depending on:

• device type;
• intended purpose;
• materials;
• design;
• method of operation;
• biological contact;
• sterilization method; and
• applicable performance or safety requirements.

Manufacturers should therefore not assume that the Ninth Schedule represents an exhaustive list of every possible medical device test.

Is there an annual increase in testing fees?

The April 2026 draft proposed that the prescribed cost of a test or analysis would automatically increase by 5% annually.

Because the final August notification is the legally controlling document, manufacturers should rely on the final Gazette wording when determining the applicable escalation mechanism and current fee rather than relying solely on the earlier draft.

This distinction is important when preparing long-term regulatory budgets.

Impact on Medical Device Manufacturers

The introduction of standardized testing fees is likely to have a practical impact across the medical device lifecycle.

1. Regulatory budgeting

Manufacturers can now factor prescribed testing costs into regulatory budgets at an earlier stage.

For example, a manufacturer requiring a sterility test can identify the prescribed fee of ₹2,000 under the Ninth Schedule, subject to the applicable regulatory and laboratory requirements.

2. Product development planning

Testing should ideally be mapped against the device's risk classification, intended purpose and applicable standards before submitting an application.

A regulatory testing matrix can help identify:

• required tests;
• applicable standards;
• testing laboratory;
• sample requirements;
• estimated testing cost;
• expected testing timeline; and
• regulatory submission milestone.

3. Increased importance of testing strategy

The fee itself may be relatively modest compared with the overall cost of medical device development.

However, manufacturers should remember that the statutory testing fee does not necessarily represent the complete cost of regulatory compliance.

Additional costs may arise from:

• sample preparation;
• repeat testing;
• specialized testing;
• external laboratory services;
• transportation;
• additional verification;
• method development;
• technical documentation; and
• corrective testing following an unsuccessful result.

Therefore, companies should distinguish between the prescribed regulatory test fee and their overall testing budget.

Impact on Medical Device Testing Laboratories

The amendment is also relevant to laboratories operating within the MDR 2017 testing framework.

Laboratories should review their:

• fee schedules;
• application procedures;
• test request forms;
• quotations;
• invoices;
• regulatory documentation;
• internal SOPs; and
• communication with manufacturers.

Where a test is not specifically covered by the Ninth Schedule, the laboratory should ensure that the basis for determining the applicable charge is properly documented and consistent with the amended regulatory framework.

Does G.S.R. 743(E) apply to every medical device test?

Not necessarily.

The Ninth Schedule specifically identifies particular tests/evaluations and their prescribed costs. It also provides a mechanism for tests that are not listed.

Manufacturers should therefore determine the exact testing requirements applicable to their device rather than assuming that every test performed during product development will automatically fall under one of the listed fees.

This is particularly important for sophisticated devices requiring specialized performance, electrical safety, software, cybersecurity, biocompatibility, mechanical, chemical, or other device-specific evaluations.

What should manufacturers do now?

Medical device companies should consider the following compliance actions:

Review the Ninth Schedule

Identify which prescribed tests apply to the company's existing and pipeline devices.

Update regulatory budgets

Incorporate the prescribed testing fees into regulatory and product-development cost estimates.

Review testing plans

Map each required test to the applicable standard, laboratory and regulatory requirement.

Review laboratory arrangements

Confirm that testing is being conducted through laboratories authorized/registered under the applicable MDR 2017 framework.

Update internal SOPs

Regulatory affairs and quality teams should update procedures dealing with test requests, laboratory selection, documentation and regulatory submissions.

Monitor fee revisions

Where the regulatory framework provides for fee escalation, companies should ensure that their budgeting and compliance databases can accommodate future changes.

G.S.R. 743(E) vs. the April 2026 Draft

It is important to distinguish the April 2026 draft notification from the August 2026 final amendment.

The April proposal introduced the concept of the Ninth Schedule and specified the proposed testing fees. The August notification represents the subsequent final amendment to MDR 2017. The final Gazette, rather than the draft, should be used for legal compliance.

This distinction is particularly important for companies that began preparing for the change based on the draft notification.

Key Takeaways

The most important points from G.S.R. 743(E) are:

1. MDR 2017 now contains a Ninth Schedule for specified test/evaluation fees.
2. The schedule covers several common medical device tests and evaluations.
3. Fees include ₹5,000 for implantation testing, ₹2,000 for sterility testing, ₹3,000 for surgical sutures and up to ₹4,500 for quantitative bacterial endotoxin testing.
4. Rule 19 is amended to connect testing/evaluation fees with the Ninth Schedule.
5. Rule 69 is amended to require the applicable Ninth Schedule fee with the relevant application.
6. Tests not specifically listed may be subject to charges determined by the relevant Director or Medical Device Testing Officer under the applicable provision.
7. Manufacturers should update their regulatory budgets, testing plans and compliance procedures accordingly.
8. The amendment was published in the Official Gazette on 19 August 2026.

Conclusion

The introduction of standardized MDR 2017 testing fees through G.S.R. 743(E) is a significant procedural development for India's medical device regulatory framework.

For manufacturers, the immediate benefit is greater visibility into the prescribed cost of several regulatory tests and evaluations. At the same time, companies should not treat the statutory test fee as the entire cost of compliance. Proper planning still requires an assessment of the applicable standards, test scope, laboratory requirements, sample requirements and regulatory submission strategy.

Medical device manufacturers and regulatory affairs teams should therefore review the Ninth Schedule, Rule 19 and Rule 69 together and update their testing and regulatory planning accordingly.

Last Updated : 22 Aug 2026