Medical Devices (Third Amendment) Rules, 2026: What Has Changed for QMS, Testing Labs and EU-Approved Devices?

The Medical Devices (Third Amendment) Rules, 2026, change a small but important part of the Medical Devices Rules, 2017. The Ministry of Health and Family Welfare has added Quality Management System (QMS) compliance to the self-certification requirements under Rules 19H and 19J, changed the heading used for government medical device testing laboratories, and added European Union countries to a specific provision under Rule 63.

The QMS change is particularly relevant to manufacturers and importers of Class A non-sterile and non-measuring medical devices. The Rule 63 amendment has a different purpose. It concerns certain investigational medical devices that lack a predicate device and already have regulatory and marketing histories in specified overseas jurisdictions.

So, this is not a new licensing system for the entire medical device industry. Its impact depends on the rule under which a business or product currently operates.

Notification at a Glance

The notification itself is only three pages long. The important part is not its length, but where these changes sit within the existing Medical Devices Rules. Rules 19H and 19J address a specific category of Class A devices, whereas Rule 63 addresses an entirely different regulatory situation.

What Are the Medical Devices (Third Amendment) Rules, 2026?

The Medical Devices (Third Amendment) Rules, 2026, do not replace the Medical Devices Rules, 2017.

They amend selected provisions of the existing rules. This distinction matters because a reader could otherwise look at the QMS amendment and assume that a completely new certification or licensing system has been introduced. That is not what it says.

The final rules make four changes:

• QMS is expressly added to the self-certification requirement in Rule 19H(2)(v).
• The same QMS wording is added to Rule 19J (2) (v).
• The marginal heading of Rule 19 is changed to “Government Medical Device Testing Laboratories.”
• European Union countries are added to Rule 63(1), Proviso (IV).

Each of these changes must be read in conjunction with the original provision. Looking only at the amendment would tell a business what words have changed, but not necessarily how those words affect its regulatory position.

Why Was This Amendment Introduced?

The final Gazette gives the legal amendments, but earlier proceedings of the Drugs Technical Advisory Board (DTAB) provide useful background on why some of these changes were proposed.

Closing the QMS gap for certain Class A devices

Chapter IIIB of the Medical Devices Rules applies to Class A non-sterile and non-measuring medical devices. Under that framework, manufacturers and importers obtain registration by submitting prescribed information through the Online System for Medical Devices rather than following the licensing framework used for other categories.

During its 91st meeting, DTAB noted that Rules 19H and 19J already addressed registration and self-certification for these devices. Still, the scope of conformity with the Quality Management System was not expressly included in those clauses.

The Board's discussion linked QMS with the need to ensure that medical devices meet applicable standards and essential principles relating to safety and performance. DTAB therefore agreed with the proposal to add QMS requirements to Rules 19H and 19J.

The 2026 amendment puts that proposal into the rule text.

Distinguishing government laboratories from private testing laboratories

There was also a terminology issue around Rule 19.

The Medical Devices Rules separately use the term “medical devices testing laboratory” to refer to laboratories registered to test or evaluate devices on behalf of manufacturers. DTAB considered that the Rule 19 heading should make it clearer that the laboratories covered there are government testing laboratories.

Its minutes specifically record the proposal to change the heading from “Medical Device Testing Laboratories” to “Government Medical Device Testing Laboratories.”

Adding the European Union to Rule 63

The EU-related change has a longer history.

DTAB records show that the exclusion of the European Union from the countries listed in Rule 63 had been raised during an India-EU Sub-Commission on Trade meeting held on 6 June 2018. The Board later recommended amending Rule 63(1) to include the European Union.

It now makes that addition in the final rules.

From Draft Rules to the Final Amendment

The Government first placed these changes before the public in draft form.

Proposed amendments to Rules 19H, 19J, Rule 19 and Rule 63. The draft notification invited objections and suggestions from people likely to be affected. The consultation period was 30 days from the date on which copies of the Gazette were made available to the public.

The final notification records that the Gazette copies were made available on 10 April 2026 and that the Central Government considered the objections and suggestions it received before finalising the rules.

For compliance purposes, the difference is straightforward:

It was a draft proposal. IT contains the final rules.

Companies that reviewed the April draft should now update their internal notes and work from the final notification.

When Do the Medical Devices (Third Amendment) Rules, 2026 Apply?

The rules say that, unless a provision states otherwise, they come into force on the date of their final publication in the Official Gazette. There are a few dates on the document, which can be confusing.

The Ministry's notification is dated 14 August 2026. The Gazette issue carrying the notification is dated 19 August 2026. Because commencement is tied to final publication rather than merely the date written below the Ministry heading, businesses should work from the final Gazette publication dated 19 August 2026.

The notification does not provide a separate transition period for the four amendments.

What Has Actually Changed?

The easiest way to understand the amendment is to separate the four changes rather than treating them as one large reform.

The first two changes affect the wording of an existing compliance declaration. The Rule 19 change mainly clarifies terminology. The Rule 63 amendment expands a country list inside an already conditional provision.

Those differences should be kept in mind before deciding what action, if any, a business needs to take.

QMS Is Now Expressly Included Under Rule 19H

Rule 19H applies to the manufacturer of a Class A non-sterile and non-measuring medical device.

Chapter IIIB states that these devices are registered via a designated online portal. Rule 19H then lists the information the manufacturer must upload. That includes manufacturing-site details, device details, classification-related declarations, and self-certification relating to safety, performance, and standards.

Before IT, clause (v) required the manufacturer to self-certify compliance with the standards specified in the Rules.

The new amendment inserts the words “and Quality Management System” after “standards”.

That may look like a small drafting change, but it changes what the manufacturer's self-certification must cover. A manufacturer relying on Rule 19H now needs to be confident that it can support a declaration covering both the applicable standards and the QMS required under the Medical Devices Rules.

This is where a proper internal quality review becomes more useful than simply updating the wording on a regulatory checklist.

What Changes Under Rule 19J for Importers?

Rule 19J deals with the import of Class A non-sterile and non-measuring medical devices.

The importer uploads prescribed information on the Online System for Medical Devices. Under the existing rule, this includes information about the importer and manufacturing site, details of the device, an undertaking about its Class A status, self-certification against essential safety and performance principles, self-certification against applicable standards, and specified overseas establishment or free-sale evidence.

IT now adds “and Quality Management System” to clause (v). For an importer, the practical issue is slightly different from that faced by an Indian manufacturer.

The importer makes the declaration in India, but the overseas manufacturing site controls the manufacturing process. The importer therefore needs enough reliable information from that manufacturer to understand whether the QMS requirement being certified is actually met.

This does not mean an importer should automatically start collecting every quality document held by a foreign manufacturer. It does mean that the basis for the self-certification should be clear and defensible.

Businesses uncertain about how much QMS evidence is relevant to a particular registration may need a product-specific review rather than a generic checklist of documents. This is one area where a medical device regulatory consultant can help identify the applicable rule and avoid unnecessary filings or unsupported declarations.

What Does “Quality Management System” Mean Under the Medical Devices Rules?

QMS is not a new term introduced in 2026.

The Medical Devices Rules already define the Quality Management System as the requirements for manufacturing medical devices specified in the Fifth Schedule.

A QMS is, in practical terms, the organised system through which a manufacturer controls how a medical device is made and checked.

It is broader than testing the finished product.

Depending on the applicable requirements, it addresses matters such as documented processes, responsibilities, manufacturing controls, quality checks, records, and problem handling.

That distinction explains why the Government chose to mention QMS alongside standards expressly.

A product can be designed against a particular technical standard, but consistent quality also depends on how the manufacturing operation is controlled day after day.

DTAB's own discussion described QMS as important for ensuring that devices meet relevant standards and essential principles of safety and performance, and referred to adherence to the Fifth Schedule.

Does the Amendment Mean Every Business Needs a New QMS Certificate?

No. IT does not itself create a new standalone QMS certificate or say that every Class A registrant must obtain a new ISO 13485 certificate.

The actual amendment is narrower.

It changes the existing self-certification requirement so that the manufacturer or importer certifies compliance with the standards and Quality Management System specified under the Medical Devices Rules.

That wording should be followed as written.

A company should therefore avoid two extremes.

One is to ignore the QMS addition, as no new licence form has been introduced. The other is to assume that the notification automatically creates a completely new certification procedure that is not actually stated in the rule.

The right compliance response begins with the device category, the applicable registration provision, and the QMS requirements relevant to the manufacturing operation.

What Has Changed for Government Medical Device Testing Laboratories?

Rule 19 now carries the marginal heading:

“Government Medical Device Testing Laboratories.”

The reason behind the wording is easier to understand when Rule 19's recent history is considered.

A 2023 amendment changed the framework to recognise State Medical Devices Testing Laboratories. It allowed a State Government to establish such a laboratory or designate an eligible laboratory for specified testing and evaluation functions.

At the same time, the Rules also use the expression “medical devices testing laboratory” for laboratories registered under a different provision to perform testing or evaluation on behalf of manufacturers.

DTAB later observed that the headings should distinguish government testing laboratories from private medical device testing laboratories.

The 2026 amendment therefore changes the heading.

It does not, by itself:

• Create a new government laboratory,
• Introduce a fresh testing procedure,
• Change test parameters,
• Establish a new laboratory registration form, or
• Introduce a separate testing fee.

For most manufacturers and importers, this is therefore a terminology and regulatory-reference issue rather than a new filing obligation.

Rule 63 Now Includes European Union Countries

The fourth change differs significantly from the QMS amendments.

Rule 63 concerns permission to import or manufacture a medical device that has no predicate device.

Under the existing rule, the authorised agent in the case of import, or the manufacturer in the case of domestic manufacture, applies to the Central Licensing Authority in Form MD-26 along with the prescribed information and fee. Where permission is granted, it is issued in Form MD-27.

The rule also contains several provisos addressing situations in which clinical data requirements may be treated differently.

One of those provisos covered devices approved by regulatory authorities in the:

• United Kingdom,
• United States of America,
• Australia,
• Canada, or
• Japan.

IT inserts “European Union countries” after Japan.

That is the legal change.

What it does not do is give every EU-approved medical device an automatic right to enter the Indian market.

What Was the Earlier Rule 63 Position?

Under the pre-amendment wording, results of clinical investigation could, subject to the rule, not be required to be submitted where a regulatory authority had approved an investigational medical device in one of the listed countries.

But foreign approval was only one part of the condition.

The rule also required that the device have been marketed in that country for at least two years. The Central Licensing Authority had to be satisfied with its safety, performance and pharmacovigilance data. The provision further addresses whether there is evidence or a theoretical possibility of differences in behaviour and performance in the Indian population and requires a written undertaking concerning post-market clinical investigation.

So even before the EU was added, the provision did not operate as a simple “approved abroad = automatically approved in India” rule.

That remains true after the amendment.

What Does the EU Addition Change in Practice?

The main change is that qualifying regulatory history from European Union countries can now fall within this particular Rule 63 proviso.

For an applicant with a device that does not have a predicate device, this may be relevant where the product already has the required approval and marketing history in an EU country.

The applicant still needs to satisfy the remaining conditions.

The Central Licensing Authority also continues to have a regulatory role. IT has not removed the Rule 63 permission process.

This means phrases such as “EU medical devices are now exempt from Indian clinical investigation” would be too broad.

A more accurate way to describe the amendment is:

• EU countries have been added to the overseas jurisdictions recognised under a conditional Rule 63 provision in which clinical investigation results may not be required to be submitted if the prescribed conditions are met.
• For companies dealing with such products, a review of medical device import compliance services may be useful before relying on the amended provision, particularly where foreign approvals, marketing history and Indian regulatory evidence need to be read together.

Why Was the European Union Added?

The Government's regulatory discussion on this issue dates back several years.

Minutes of the 91st DTAB meeting record that the matter had been raised during the India-EU Sub-Commission on Trade held on 6 June 2018. The concern was that Rule 63 referred to the US, the UK, Australia, Canada, and Japan, but not the EU.

DTAB subsequently recommended amending Rule 63(1) to include the European Union.

The final 2026 amendment gives effect to that recommendation.

For businesses, the important takeaway is not that Indian requirements have been removed for EU devices. The change is that EU regulatory history now receives express recognition under this provision, subject to the conditions already set out in Rule 63.

Who Should Pay Close Attention to the Amendment?

The amendment is not equally relevant to every company in the medical device sector.

A manufacturer of a Class C device with no connection to Rule 63, for example, should not assume that a new Rule 19H registration requirement suddenly applies to it.

The first question should always be: Which amended rule actually covers this product or activity?

What Does This Mean for Class A Medical Device Manufacturers?

For a manufacturer already registered under the Class A non-sterile and non-measuring route, the practical focus should be on self-certification.

The company should review whether its quality system is aligned with the relevant Fifth Schedule requirements and whether its regulatory records are consistent with that position.

This is not simply a paperwork exercise.

When a business signs a self-certification, the value of that declaration comes from the records and controls behind it.

Rule 19L also requires manufacturers and importers under this chapter to maintain relevant manufacturing or import records together with sales or distribution records and to produce specified records when requested by the licensing authorities.

The amendment therefore makes it sensible to review QMS evidence alongside the existing registration record, rather than updating a single sentence in isolation.

What Does This Mean for Importers?

Importers have an extra layer to manage because the manufacturing site is outside India.

Rule 19J places the self-certification obligation on the importer. At the same time, the underlying quality processes will generally sit with the overseas manufacturer.

A sensible review may therefore cover:

• Whether the device is correctly treated as Class A non-sterile and non-measuring,
• Whether the overseas manufacturing site details match the registration record,
• What information supports QMS conformity
• Whether applicable product standards have been correctly identified,
• Whether free-sale or establishment documentation remains consistent with the registration, and
• Whether the submitted declaration can be supported by the records available to the importer.

Not every importer will need the same documents. The exact evidence depends on the product, manufacturing arrangement, and regulatory record.

A medical device regulatory consultant or an experienced internal regulatory team can be useful here, as the aim is not to compile the largest possible file. It is to identify what actually supports the legal declaration.

Does IT Create a New License or Registration?

IT does not introduce a new license category, a new registration form, or a separate application merely because QMS has been added to Rules 19H and 19J.

• The Class A registration route already existed.
• The amendment changes what is expressly covered by the self-certification within that route.
• Similarly:
• The Rule 63 permission mechanism already existed,
• Form MD-26 and Form MD-27 already formed part of that framework,
• Rule 19 already dealt with testing laboratories, and
• The 2026 notification does not prescribe a new standalone government testing-laboratory filing.
• This distinction can save companies from unnecessary compliance work.
• The correct response is to update the existing applicable process rather than invent a new one.

Compliance Readiness Checklist for Medical Device Businesses

The purpose of this exercise is not to create more documents. It is to make sure the documents already relied upon tell the same regulatory story as the amended rules.

Compliance Risks Worth Avoiding

Treating the Amendment as Applicable to Every Medical Device

Rules 19H and 19J have a defined scope. They fall under the framework for Class A non-sterile, non-measuring devices. Applying these provisions to an unrelated device category can lead to the wrong compliance route.

Updating the Declaration but Not Checking the QMS

Changing the wording of a self-certification is easy. Being able to support it is the more important part. Affected manufacturers and importers should understand the evidence underpinning the QMS declaration before submitting or relying on it.

Assuming ISO Certification Is Automatically the Entire Answer

The 2026 amendment refers to the Quality Management System specified in the Medical Devices Rules. The Rules themselves link QMS to the Fifth Schedule. A certificate may be relevant in a particular compliance setting, but IT should not be rewritten to require every affected business to obtain a new ISO certificate.

Assuming Any EU Approval Is Enough under Rule 63

The amendment adds EU countries to the list. It does not delete the other conditions. A company should therefore avoid relying solely on an EU approval certificate and instead consider factors such as marketing history, safety, performance, pharmacovigilance, and other requirements under the proviso.

Confusing Rule 63 with the Regular Import Route

Rule 63 deals with medical devices without a predicate device. It is not a general shortcut for every medical device being imported from Europe.

Is This More of a Regulatory Clarification or an Additional Burden?

It is a mixture of both, although the nature of the impact differs across the four amendments.

For Class A manufacturers and importers, the QMS addition clarifies compliance expectations. That can mean additional work where QMS records were not previously reviewed as part of the registration process.

At the same time, the Government has not added an entirely separate application or licensing layer.

The Rule 63 amendment is more clearly a regulatory expansion of an existing provision. It gives EU regulatory history a place within the specified proviso. However, the protection built into the rule remains: the applicant must still meet the conditions, and the Central Licensing Authority must still be satisfied.

The Rule 19 heading is the least burdensome of the changes. Its main purpose is clarity.

What Should Businesses Do Now?

The best response is not to reopen every medical device file in the company.

Start with the products that actually fall under one of the amended provisions.

• First, check classification. Manufacturers and importers should determine whether any product is registered as a Class A non-sterile, non-measuring medical device.
• Next, review the current registration record. Review the self-certification used under Rule 19H or Rule 19J, and ensure the amended QMS requirement is understood.
• Then look behind the declaration. Quality and regulatory teams should assess whether the available QMS records provide a reasonable basis for certification.
• For imports from the EU, separate ordinary imports from Rule 63 cases. The fact that a device comes from Europe does not, by itself, make the new proviso relevant.
• For genuine Rule 63 cases, review every condition. Country approval is only one part of the analysis.
• Update internal references. SOPs, regulatory trackers and compliance notes that reproduce the old wording of the affected provisions should be corrected.
• Keep watching official CDSCO updates. If operational guidance is issued later on implementation, affected businesses should assess whether it changes their existing processes.

How Corpseed Can Help With Medical Device Regulatory Compliance

A three-page amendment can still raise difficult questions when applied to an actual product.

A manufacturer may know that its product is Class A but be unsure whether the non-sterile and non-measuring registration route applies. An importer may have QMS documents from an overseas manufacturer but still need to understand whether those records adequately support the Indian self-certification. A company dealing with a device without a predicate may have European approval but may not know whether the complete Rule 63 conditions are satisfied.

Corpseed can support medical device businesses in areas such as:

• Medical device regulatory applicability assessment: Reviewing the product, classification, and business activity to identify the relevant provisions of the Medical Devices Rules.
• Class A medical device registration support: Assistance with the registration framework applicable to Class A non-sterile and non-measuring devices.
• Quality Management System compliance review: Assessing the QMS requirements relevant to Rules 19H and 19J and reviewing whether available records support the required regulatory position.
• CDSCO registration services: Supporting businesses with applicable CDSCO registrations, submissions and regulatory documentation.
• Medical device import compliance services: Reviewing the regulatory route for imported devices, overseas manufacturing information and India-specific requirements.
• Rule 63 regulatory assessment: Examining whether the device falls within the no-predicate-device framework and whether the amended EU provision may be relevant.
• Technical document review: Checking regulatory records, declarations, product information and supporting documents for consistency before submission.
• Medical device compliance gap assessment: Comparing existing documentation and processes against the applicable Medical Devices Rules.
• Overseas manufacturer and authorised-agent support: Helping organise information used for Indian medical device regulatory filings involving a foreign manufacturing site.
• Medical device registration and licence support: Assisting with applications, amendments or ongoing regulatory processes where the applicable law requires them.
• Regulatory monitoring: Tracking later CDSCO and Ministry notifications that may affect the product or regulatory route.

Using a medical device regulatory consultant is most useful where there is a genuine question of applicability or documentation. The aim should be to identify the right route first and file only what the law actually calls for.

Corpseed's role is to assist businesses with regulatory interpretation, documentation, and filing support. Approval, permission, registration, exemption and other regulatory decisions remain with CDSCO and the competent licensing authorities.

Businesses reviewing IT, Class A registration, QMS compliance, or the revised Rule 63 position can use Corpseed's medical device compliance services to organise the regulatory review and address gaps before the next filing or regulatory interaction.

Key Takeaways

The Medical Devices Third Amendment Rules 2026 are targeted amendments rather than a new medical device regulatory system.

The most immediate change is for manufacturers and importers of Class A non-sterile and non-measuring devices, because QMS is now expressly included in the self-certification wording under Rules 19H and 19J. The other changes should also be read carefully:

• IT contains the final amendment to the Medical Devices Rules, 2017.
• The Ministry notification is dated 14 August 2026 and appears in Gazette No. 678 dated 19 August 2026.
• Rules 19H and 19J now expressly include the Quality Management System alongside standards.
• The QMS referred to under the Rules is connected with the Fifth Schedule.
• The Rule 19 marginal heading is now “Government Medical Device Testing laboratories.”
• European Union countries have been added to Rule 63(1), Proviso (IV).
• EU approval alone does not automatically remove Indian regulatory requirements.
• The notification does not create a new general license or a new registration category.
• Affected companies should first check applicability and then review the records behind their existing regulatory declarations.