Medical Device Rules, 2017 – Draft Amendments (Dec 2025)
What Has Changed, Why It Matters, and How Industry Should Respond
The Ministry of Health & Family Welfare has released draft amendments to the Medical Device Rules (MDR), 2017 (Gazette dated 4 December 2025). These changes are not cosmetic. They directly impact Class A manufacturers, IVD players, testing laboratories, importers, and overseas manufacturing sites.
This newsletter breaks down each amendment, explains the regulatory intent, and provides practical examples to help manufacturers and regulatory teams prepare proactively.
1. Rule 44 – Labeling: Inclusion of Registration Number for Class A Devices
What changed?
Rule 44 clauses (m) and (n) now allow Registration Number (Reg. No.) instead of a Manufacturing Licence (M.L.) or Import Licence for:
- Class A Non‑Sterile, Non‑Measuring medical devices
Why this matters
Earlier, labeling language was ambiguous and often interpreted strictly, creating confusion for Class A manufacturers who are registered, not licensed.
Example
A manufacturer of non-sterile examination gloves (Class A) can now legally label:
“Reg. No.: MD/REG/XXXX”
instead of forcing a licence number that does not exist for Class A devices.
2. Rule 45 – Sale & Distribution Certificates: Registration Number Recognized
What changed?
- Rule 45(e) and its first proviso now recognize Registration Numbers for Class A devices in place of licence numbers.
Practical impact
Distributors and wholesalers dealing exclusively with Class A devices no longer face documentation mismatches during inspections.
Example
A distributor selling Class A surgical dressings can present a Registration Certificate instead of a Manufacturing Licence during state inspections.
3. Chapter IX – Removal of “Notified Body” Reference
What changed?
The words “AND NOTIFIED BODY” are removed from the Chapter IX heading.
Regulatory intent
This aligns MDR with India’s centralized regulatory model, clarifying that testing, inspection, and certification authority remains with CDSCO and notified testing labs, not EU‑style notified bodies.
Example
Manufacturers should not expect third‑party notified body certifications to substitute Indian regulatory approvals.
4. Rule 85 – New Compliance Obligation for Registered Testing Labs
New sub‑rule (xi)
Registered medical device testing laboratories must submit test/evaluation reports in newly introduced Form MD‑44.
Why this is critical
This standardizes lab reporting and strengthens enforcement actions related to sub‑standard or non‑compliant devices.
Example
If CDSCO draws samples of an IVD kit from the market, the testing lab must issue its results strictly in Form MD‑44, not a generic lab report.
5. Rule 85(ix) – Inspection Book Format Clarified
What changed?
Inspection book must now be maintained specifically in Form MD‑11.
Impact
Removes ambiguity during audits and inspections.
Example
A Class C implant manufacturer must ensure their inspection records follow MD‑11 structure, not internal templates.
6. Second Schedule – Overseas Manufacturing Sites (IVDs)
What changed?
Second Schedule Sr. No. 39(h) now clearly covers:
One overseas site manufacturing Class C or Class D IVD medical devices
Why this matters
This tightens oversight on foreign IVD manufacturers supplying to India.
Example
A European manufacturer of Class D HIV diagnostic kits supplying to India must ensure proper site registration and compliance under MDR.
7. Fifth Schedule – Applicability Extended to IVDs
What changed?
The Fifth Schedule now explicitly applies to:
- Medical devices AND In‑Vitro Diagnostic medical devices
Impact
IVD manufacturers must comply with quality system and audit requirements earlier assumed to apply mainly to non‑IVD devices.
Example
An IVD reagent manufacturer must now demonstrate Fifth Schedule compliance during audits.
8. Fifth Schedule, Annexure A – Environmental Controls Clarified
What changed?
Environmental requirements are now explicitly applicable to:
- All manufacturing activities
- Including IVD kits and reagents
Example
A rapid test kit manufacturer must justify temperature, humidity, and contamination controls during CDSCO inspections.
9. Perpetual Validity of Licences & Registrations (Major Reform)
Forms impacted
- MD‑2, MD‑40 (Registration)
- MD‑5, MD‑6, MD‑9, MD‑10, MD‑15 (Licences)
What changed?
Licences and registrations are now valid in perpetuity, subject to:
- Payment of retention fees
- No suspension, cancellation, or surrender
Why this is a big shift
Moves India closer to US FDA‑style establishment lifecycle management, reducing renewal burden.
Example
A Class C manufacturer no longer files licence renewal every few years but must track retention fee deadlines strictly.
10. Form MD‑11 – Expanded to Cover Registration Holders
What changed?
- “Licensee” replaced with “Licensee or Registration holder” across the form
- Physical signature/seal allowed (digital signature no longer mandatory)
Practical benefit
Simplifies compliance for small Class A manufacturers operating in semi‑digital environments.
11. Sample‑Related Forms (MD‑36, MD‑37, MD‑38) – Structured Data Tables Added
What changed?
Mandatory tables added capturing:
- Device name
- Batch/Lot number
- Manufacturing & expiry date
- Quantity
- Premises address
Impact
Improves traceability and enforcement during investigations.
Example
During a complaint investigation, CDSCO can now track an affected batch within minutes.
12. Introduction of Form MD‑44 – Test & Evaluation Report
What is MD‑44?
A comprehensive, legally defensible test report format covering:
- Physical, chemical, biological testing
- IVD sensitivity & specificity
- Opinion on standard vs non‑standard quality
Why this matters
MD‑44 will likely become the primary evidence document in:
- Show cause notices
- Product recalls
- Prosecution cases
Example
A failed sterility test reported in MD‑44 can directly trigger a Class I recall.
Final Thoughts: What Should Industry Do Now?
✔ Review labeling templates for Class A devices
✔ Update SOPs to reference MD‑11 and MD‑44
✔ Train QA & RA teams on retention fee tracking
✔ Assess overseas IVD site compliance
✔ Strengthen batch traceability systems
These draft amendments clearly signal a shift toward simplification with stronger post‑market control.
If implemented, they will reward regulatory maturity, not paperwork volume.
If you found this breakdown useful, feel free to share it with your QA/RA network.
https://advocategandhi.com/wp-content/uploads/2025/12/Medical-Devices-Amendment-Rules-2024.pdf