Posted by If you work with Operation Theatre (OT) equipment in India—buying, importing, manufacturing, or selling- you live under the Medical Devices Rules, 2017 (MDR 2017) and the watchful eye of CDSCO. This post breaks down the CDSCO classification of medical devices in the operating theatre, how the CDSCO Operation Theatre Medical Equipment license actually works, and the paperwork you’ll really be asked for.
What Counts as an Operation Theatre Device for CDSCO
CDSCO issues category-wise, risk-based classifications. One of those categories is the Operating Theatre (OT). In September 2021, CDSCO published a list of OT-specific devices with risk classes A, B, C or D (A = lowest risk; D = highest overall).
A Word of Caution
Many importers and manufacturers miss a practical yet subtle nuance. Devices commonly found in an OT, like anaesthesia workstations, ventilators, defibrillators, imaging gear, may be classified under other CDSCO categories (e.g., Anesthesiology, Respiratory, General Hospital, Interventional Radiology). This happens even though they physically sit in the OT. So when you’re mapping your portfolio, don’t stop at the “OT” list; check the other category lists too.
Do You Need a Special CDSCO Operation Theatre Medical Devices License?
Not exactly. In India, the license depends on what you do with the device. If you’re an importer, you apply in Form MD-14 and, if approved, you receive Form MD-15. This is your CDSCO import license for Operation Theatre Medical Devices. There’s an official CDSCO MD-15 checklist (and a specimen MD-14 form) you’ll be measured against.
If you manufacture medical devices used in OT, apply in following forms based on the device’s class:
- Class A & B: Apply Form MD-3 & Form MD-4. License is Form MD-5 & Form MD-6 (issued by State Licensing Authority).
- Class C & D: Apply Form MD-7 & Form MD-8. License is Form MD-9 & Form MD-10 (issued by Central Licensing Authority).
- Sell/stock/distribute (wholesale/retail): You need Form MD-42. It is the registration certificate to sell, stock, exhibit or offer for sale or distribute medical devices. If you plan to import and sell, Form MD-42 is the pre-requisite license.
So when you hear “CDSCO Operation Theatre Medical Equipment license” or “CDSCO Operation Theatre Medical Devices license,” it’s about MD-15 (import) or MD-5 & MD-6, MD-9 & MD-10 (manufacture) and, often, MD-42 (sale/distribution) layered on top.
Some Examples of Risk Classes of CDSCO Operation Theatre Medical Devices
CDSCO’s OT list maps every device and its intended use. It then assigns it a risk class. A few examples that your regulatory file may include are:
- Retractors/distractors – Class A
- Suction systems (portable, electrical/pneumatic, or vacuum line) – Class A
- Operation table systems (powered and manual variants) – Class A
- Surgical light system – Class A
- Sterile hemostatic clip applier – Class B (Non-sterile is Class A)
- Scalpel blade – Class B
- General-purpose electrosurgical unit – Class C
- Warming high-flow infusion pump / high-flow blood transfusion pump – Class C
- Multiparameter monitor with critical parameters – Class C
When in doubt, look at the official OT list. If your device is absent, check the other CDSCO Medical Device Classification list.
Official Classification of OT Medical Devices According to CDSCO
Refer to this table to find out the risk class of your device.
|
S. No. |
Device name |
Risk Class |
| 1 | Distractor / Retractors | A |
| 2 | Suction system portable, Electrical / Pneumatic | A |
| 3 | Suction system operated by vacuum | A |
| 4 | Operation table system | A |
| 5 | General-purpose diagnosis/treatment table | A |
| 6 | Surgical light system | A |
| 7 | Non-sterile Hemostatic clip applier | A |
| 8 | Sterile Hemostatic clip applier | B |
| 9 | Hemostatic knife | B |
| 10 | Non-sterile Scalpel | A |
| 11 | Sterile Scalpel | B |
| 12 | Scalpel blade | B |
| 13 | Non-sterile Surgical forceps | A |
| 14 | Sterile Surgical forceps | B |
| 15 | General-purpose electrosurgical unit | C |
| 16 | Long-term use enterostomy feeding tube | C |
| 17 | Warming high-flow infusion pump | C |
| 18 | High-flow blood transfusion pump | C |
| 19 | Non-sterile Staple remover | A |
| 20 | Sterile Staple remover | B |
| 21 | Non-sterile Surgical punch | A |
| 22 | Sterile Surgical punch | B |
| 23 | Non-sterile Surgical file | A |
| 24 | Sterile Surgical file | B |
| 25 | Non-sterile Blood vessel surgical stripper | A |
| 26 | Sterile Blood vessel surgical stripper | B |
| 27 | Non-sterile Surgical probe | A |
| 28 | Sterile Surgical probe | B |
| 29 | Multiparameter monitor with critical parameters | C |
| 30 | Surgical robot unit | B |
| 31 | Motorized diagnostic imaging view box | A |
| 32 | General-purpose manually-operated operation table | A |
| 33 | Powered general- purpose operation table | A |
| 34 | Operation table system | A |
How to Get an Import License for Operation Theatre Medical Devices (MD-15 via MD-14)
This is the path to follow if you’re bringing devices into the Indian market:
1. Application: File MD-14 on the CDSCO portal. Your license, if granted, comes as MD-15.
2. Core documents: The official CDSCO checklist for MD-15 is your north star. The essentials include device details, Free Sale Certificate, regulatory approvals in other markets (if any), labelling/IFU, QMS evidence, clinical/performance data where relevant, PMS/vigilance approach, and batch/CoA or software version evidence as applicable.
3. Local presence: Traditionally, Foreign manufacturers appoint an authorized Indian agent. In practice, if you are the Indian entity of record, you’ll still need the sale/distribution registration (MD-42) to legally stock and sell.
4. If no predicate device exists in India: Get permission in MD-27 (the “no predicate” pathway) before a full marketing license.
How to Get a Manufacturing License for OT Devices?
If you build medical devices in India, here are the license types and expectations from you:
| Steps | Applies To | Forms (Application → License) | Licensing Authority | What reviewers expect (key artifacts) | Practical notes |
| Manufacturing license | Class A & B OT devices (e.g., surgical lights, OT tables, non-sterile instruments) | MD-3 → MD-5 | State Licensing Authority (SLA) | • Device description & intended use (mapped to OT classification)
• Risk class rationale • Essential Principles checklist (MDR 2017) • ISO 13485 certificate (valid & scope-matched) • Site Master File, plant layout • Process validations (sterilization, packaging, cleaning where relevant) • Test reports to applicable BIS/IEC/ISO standards • Labeling/IFU • PMS plan (complaints, vigilance/MvPI flow) • QA/QC SOPs, calibration & equipment logs, training records |
• Expect a site inspection by SLA
• Keep forms/annexures naming exact device models • Keep labeling text consistent with intended use and application wording |
| Manufacturing license | Class C OT devices (e.g., electrosurgical units, multiparameter patient monitors, warming high-flow pumps) | MD-7 → MD-9 | Central Licensing Authority (CDSCO HQ) | • Everything from Class A/B plus
• Evidence aligned to the MD-9 checklist • Electrical safety/EMC (e.g., IEC 60601 series) • Software lifecycle file (if software/firmware present) • Clinical/performance evidence proportional to risk • Usability (IEC 62366) where applicable |
• Build your dossier to the MD-9 checklist order
• Early gap-assessment against standards • Keep a clean traceability matrix: Intended use → risks → controls → tests → labeling |
Post-Market Surveillance (PMS) & Materiovigilance – Why Is It an Ongoing Responsibility
Once your OT device is on the market, the job is not complete. CDSCO (via DCGI circulars) has repeatedly emphasized the timely reporting of medical device adverse events to MvPI (Materiovigilance Programme of India). The Indian Pharmacopoeia Commission runs MvPI and publishes the official adverse event reporting forms and toolkit. Build internal SOPs so incidents move quickly from hospital to manufacturer/importer to IPC.
Common Pitfalls While Applying for the License
Some misconceptions and consequent mistakes that will prevent you from getting approved are as follows:
- Calling it the wrong license. There’s no single OT license. Your license type follows your activity (import/manufacture/sell) and your device’s risk class.
- Forgetting MD-42 for the sales/stocking entity. Audits by the CDSCO professionals detect it quickly.
- Vague intended use. The risk class hinges on intended use. Copy it carefully from your IFU and keep it consistent across forms and labels.
- Weak PMS loop. MvPI reporting is not optional, so document and train.
How Dueran Consultant Helps You
At Dueran Consultant, our job is to make the approval process easier for you. Be it Manufacturing license or Import License, we’ll provide you with complete support and guidance from the beginning. Just share with us your device details and we’ll take you through the steps needed to complete the approval process. Not only this, but we’ll also create personalized strategies to enable your business to succeed in the Indian medical device market.
