India Change Management: Sixth Schedule and Deemed Approval

1. Key takeaways

India divides changes into major changes and minor changes, determined under the Sixth Schedule of the Medical Devices Rules, 2017. A major change requires prior approval from the Central Licensing Authority, which must state its position within 60 days; if no reply is received within that period, the change is deemed approved (Rule 38(1)(v)(vi)). A minor change requires only written intimation within 30 days of its occurrence (Rule 38(1)(vii)).

• Classification first: whether a change is major or minor is decided against the Sixth Schedule, not by internal judgement.
• Prior approval for major changes: the application goes in before the change is implemented, and the CLA has 60 days to decide.
• Deemed approval applies: silence beyond 60 days operates in the applicant’s favour under Rule 38(1)(vi).
• Minor changes run on notice, not approval: written intimation within 30 days after the change is enough.

2. Legal basis

The obligations for both categories, and the parallel rules on the manufacturing side, are set out below. The deadlines and the deemed-approval mechanism are statutory, not administrative practice.

3. Expert insights

Insight 1: India has written deemed approval into the text. This is one of the core design features for which the MDR 2017 has been described as offering high certainty: if the regulator does not reply in time, the applicant prevails. Few markets provide this, and it changes the negotiation position of a company facing a slow review — the clock, not the file, decides the outcome after 60 days. The practical corollary is that a well-documented submission filed on day one is worth more than a perfect submission filed late.

Insight 2: the deadlines differ between import and manufacturing. On the import side a major change is subject to 60-day deemed approval; on the manufacturing side the period is 45 days. The same substantive change therefore carries a different waiting period depending on the path under which the product is held, which matters when a group holds both an import licence and a manufacturing licence for related products. Planning a single change across both licences means planning to the longer of the two periods.

Insight 3: a change in constitution is a separate obligation. A change in the corporate constitution of the overseas manufacturer or the agent — shareholders, organisational form — must be notified to the CLA in writing within 30 days. This provision is often treated as a corporate-affairs matter and omitted from regulatory reporting, even though it sits in the same rule as the product-related change duties. The 30-day clock starts from the change itself, so the notification cannot wait for the annual compliance review.

Insight 4: the Sixth Schedule is the criterion, not common sense. The major/minor divide is determined by the Sixth Schedule. For example, under the analysis of the rules, a change in the manufacturer’s name or address is a major change, while a design change that does not affect specifications, intended use, performance or stability is a minor change. Classifying by intuition rather than by the schedule is how companies end up notifying a major change as a minor one — which is a substantive violation, not a paperwork error. The reverse error also occurs: treating a minor change as major and waiting 60 days for a decision that was never needed.

4. Practical recommendations

• Build an India change-classification card. GRZAN prepares a change-classification card for clients that maps the changes a company commonly makes — packaging change, change of material supplier, addition of a model, relocation of premises, change of company name, software version upgrade — line by line against the Sixth Schedule, marking each as major or minor, the applicable deadline, and whether prior approval is required.
• Use the card before the change, not after. The purpose of the card is to move change management from after-the-fact judgement to a look-up that happens before implementation.
• Never downgrade a major change to a minor one to save time. Mis-notifying a major change as minor is a substantive violation, and the 60-day deemed approval only helps those who filed in the correct category.
• Record the filing date of every major change. Because deemed approval runs from the prescribed period, the submission date is the evidential anchor if the CLA’s reply never arrives.
• Keep corporate changes on the regulatory calendar. Shareholder or organisational changes at the manufacturer or agent level should be routed to the regulatory team, not only to company secretarial staff.

5. Verification checklist

• □ Each change has been classified against the Sixth Schedule (major/minor)
• □ Major changes have been submitted to the CLA before implementation, with the submission date recorded
• □ The deemed-approval date has been calculated on the 60-day (import) / 45-day (manufacturing) basis
• □ Minor changes have been notified within 30 days of occurrence
• □ Changes in corporate constitution have been notified in writing within 30 days

Regulatory information verified as of 27 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including India. Our team prepares dossiers to CDSCO expectations, manages SUGAM submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com