India has updated its medical device regulations again, and for U.S. MedTech companies looking at the Indian market, there are a few changes worth reviewing.

By Himani Singh

In August 2026, India’s Ministry of Health and Family Welfare notified two amendments to the Medical Devices Rules, 2017. The updates address outsourced sterilization, testing fees, quality management self-certifications, for certain Class A non-sterile and non-measuring devices, and reliance on approvals from recognized foreign jurisdictions.

The good news? Some of these changes could make entering the Indian market more straightforward.

The important caveat? They do not create a blanket fast-track approval process for U.S. medical devices.

Here’s what companies should know.

Outsourcing Sterilization Just Got a Little Simpler

Many medical device manufacturers outsource sterilization rather than handling it in-house.

In 2025, India’s Central Drugs Standard Control Organization clarified that manufacturers generally do not need a separate loan license simply because sterilization is outsourced. Instead, the manufacturer can use an appropriately licensed sterilization facility while remaining responsible for quality control and final product release.

The 2026 reforms build on that approach.

If sterilization takes place at another licensed facility, the device label must identify the sterilization site’s manufacturing licence number using one of the prescribed descriptions or abbreviations. Manufacturers have six months from the amendment’s notification date to comply.

For manufacturers, that means less regulatory duplication, but more emphasis on traceability.

Companies using third-party sterilization providers should review:

• sterilization agreements and facility licences;
• process validation responsibilities;
• deviation and quality control procedures;
• product release controls; and
• labels, packaging specifications and change control documentation.

In short, outsourcing may be easier, but responsibility still sits with the manufacturer.

Testing Costs Are Becoming More Predictable

Another practical change involves testing fees.

The new Ninth Schedule establishes standardized fees for certain tests and evaluations, including sterility testing, implantation testing, surgical dressings, syringes, sutures and bacterial endotoxins.

For tests that are not listed, the applicable fee will be determined by the Director or Medical Device Testing Officer. Listed fees will also increase by five percent annually.

For companies planning an Indian launch, having standardized fees should make budgeting easier.

But cost certainty is not the same as timeline certainty.

The new schedule does not guarantee laboratory availability, turnaround times, or regulatory approval within a particular timeframe. Companies should still build flexibility into their launch schedules.

India Is Expanding Its Reliance on Foreign Regulatory Approvals

This is potentially one of the more useful changes for international MedTech companies.

India’s Third Amendment adds European Union countries to the jurisdictions recognized under Rule 63. The United States, United Kingdom, Australia, Canada and Japan were already included.

Rule 63 may be relevant when a medical device does not have a predicate device in India.

For U.S. companies whose devices are also approved by the regulatory authorities of, and marketed in, an EU country, the change provides an additional potentially qualifying regulatory history under Rule 63. EU safety, performance and pharmacovigilance data may also supplement the company’s U.S. regulatory records.

That could be particularly valuable when a device has a longer EU marketing history or a more extensive EU evidence package. However, the amendment does not expressly provide that U.S. and EU marketing periods may be combined to satisfy the two-year marketing requirement.

There is an important distinction, though: foreign approval does not equal automatic approval in India.

The Rule 63 pathway remains conditional and subject to the Central Licensing Authority’s determination. Clinical-investigation results may not be required where the device has been approved by the regulatory authorities of a listed jurisdiction and marketed there for at least two years. The Central Licensing Authority must also be satisfied with the device’s safety, performance and pharmacovigilance data.

In addition, there must be no evidence or theoretical possibility, based on existing knowledge, that the device will behave or perform differently in the Indian population. The applicant must provide a written undertaking to conduct a post-marketing clinical investigation under a protocol approved by the Central Licensing Authority.

Accordingly, FDA authorization or a qualifying EU approval and marketing history may support a request not to submit clinical-investigation results, but neither produces an automatic waiver or approval in India.

Quality Management Requirements Are Now More Explicit

The Third Amendment also expressly adds “Quality Management System” to the self-certification requirements for certain Class A non-sterile and non-measuring devices.

This applies to manufacturers and importers using India’s online registration pathway.

For companies already operating under this route, the practical takeaway is fairly simple: review your self-certification language and make sure your underlying quality documentation supports what you are certifying.

This does not create a new licensing regime. It expressly adds Quality Management System compliance to the existing self-certification requirements for this Class A non-sterile and non-measuring registration route.

What Should U.S. MedTech Companies Do Now?

If India is part of your growth strategy, start by determining exactly which regulatory pathway applies to each product. Device classification matters, as does whether you are importing, manufacturing domestically, registering a Class A device, or relying on Rule 63.

From there, companies should:

account for the new testing fees and annual increases when building launch budgets.

• map each product’s approval and marketing history across the U.S., EU and other recognized jurisdictions;
• review existing safety, performance, clinical and pharmacovigilance data for its applicability in India;
• identify products that rely on outsourced sterilization and review licences, agreements, validation records and labels;
• update applicable Class A self-certifications to expressly address quality management systems; and
• account for the new testing fees and annual increases when building launch budgets.

The Bottom Line

India’s 2026 medical device reforms are more of a targeted tune-up than a complete regulatory overhaul.

For U.S. MedTech companies, however, those targeted changes still matter. They can reduce unnecessary duplication, make certain costs easier to anticipate, and allow qualifying EU approval and marketing histories to support a request not to submit clinical-investigation results under Rule 63.

The key is not to mistake greater flexibility for automatic approval.

Companies considering the Indian market should review their regulatory pathway, supporting evidence, quality arrangements and labeling requirements early. Doing that work upfront can help avoid unnecessary rework and delays once the application process is underway.

Bagchi Law works with U.S. and Indian companies navigating cross-border market entry, including the corporate, commercial and contractual arrangements involved in manufacturing, licensing, distribution and commercialization in India.