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September 25, 2026October 12, 2026
CDSCO, Compliance Guides, Import Compliance, Medical Devices

CDSCO Licence for Bone Cement in India: Class D Registration, ISO 5833 and Process

Bone cement (PMMA) anchors joint prostheses to bone and fills bony defects, curing in the body during surgery and bearing load thereafter. Because it is an implanted, load-bearing material, CDSCO classifies bone cement at the highest tier, Class D — and antibiotic-loaded cement is additionally a drug-device combination. This guide covers the full CDSCO registration pathway for bone cement under the Medical Devices Rules, 2017 — classification, licence route, ISO 5833, the antibiotic fork, the documents, the fees and the timeline. This guide explains CDSCO registration for bone cement in India — risk class, licence forms, standards, documents, fees and timeline.

Is CDSCO Registration for Bone Cement Mandatory in India?

Yes. Also, bone cement is a notified Class D medical device and cannot be manufactured, imported or sold in India without a CDSCO licence. Because it is Class D, a domestic manufacturer applies to the Central Licensing Authority in Form MD-7 for a Form MD-9 licence. Moreover, an importer applies in Form MD-14 for a Form MD-15 import licence. Plain and antibiotic-loaded cements are covered — antibiotic-loaded cement additionally engages the drug route for its antibiotic.

Risk Classification of Bone Cement

Every medical device in India falls into one of four risk classes (A, B, C, D) under the First Schedule of the Medical Devices Rules, 2017. In addition, the class fixes the authority, the form, the fee, the audit route and the timeline.

Also, bone cement is classified as Class D (high risk). Bone cement is an implanted, load-bearing material that cures in the body and is central to joint fixation, which places it in the highest risk class (Class D) under the First Schedule. Additionally, where a device could fall in two classes the higher class applies, and an accessory is classified in its own right. Always confirm against the current CDSCO classification list.

CDSCO Licence for Bone Cement: Which Licence You Need

To manufacture bone cement in India (Class D) — apply in Form MD-7 to the Central Licensing Authority (CDSCO headquarters). The licensing authority grants the licence in Form MD-9. A CDSCO joint audit team inspects the manufacturing site before the licensing authority grants the licence — site inspection is mandatory for Class C and D.
To import bone cement (any class) — the overseas manufacturer appoints an Indian Authorised Agent who files Form MD-14 with the Central Licensing Authority; CDSCO grants the import licence in Form MD-15.
Test licence — for a small quantity imported or made for testing, evaluation, demonstration or clinical investigation: Form MD-12 application, Form MD-13 licence.
Loan licence — using another licensee’s approved premises: Form MD-4 (Class A/B) or Form MD-8 (Class C/D) for a licence in Form MD-6 or MD-10.

Applicable Standards for Bone Cement

Bone cement is evaluated against the acrylic-cement standard plus biocompatibility and, for antibiotic cement, the drug component:

ISO 5833 — implants for surgery: acrylic resin cements.
ISO 10993 series — biocompatibility of the cured and curing cement.
Setting, mechanical (compressive/bending) and exotherm performance per ISO 5833.
Doughing/working-time and residual-monomer data.
ISO 11135 / 11137 — sterilisation validation of the components.
For antibiotic-loaded cement, the antibiotic (identity, dose, elution and stability) is assessed as a drug-device combination.

Documents Required for CDSCO Registration of Bone Cement

Whether you file for a manufacturing or an import licence, CDSCO expects the same core technical dossier built around the device:

Covering letter and application form — Form MD-3 / MD-7 (manufacture) or Form MD-14 (import) on the CDSCO Medical Device Online portal, stating every device, variant and site.
Device Master File (DMF) — device description and intended use, materials, design and manufacturing information, ISO 14971 risk file, verification/validation data, sterilisation validation where applicable, shelf-life/stability data and the Essential Principles checklist.
Plant Master File (PMF) — site layout, equipment, utilities/HVAC, organisation chart with competent technical staff and the QMS procedures governing production.
ISO 13485 QMS certificate — current, with a scope covering the device.
Essential Principles of Safety and Performance — a completed checklist mapping the device against each applicable principle with the standard/evidence relied on.
Risk management file (ISO 14971) — hazards, risk controls and residual-risk justification.
Test / performance reports — against the applicable BIS/IS or ISO/IEC standards from an accredited laboratory.
Labels, IFU and packaging — meeting the labelling requirements of the Medical Devices Rules (manufacturer, licence number, sterile status, single-use symbols).
Undertaking and declaration of conformity to the Essential Principles and applicable standards.
Government fee receipt — paid online through the CDSCO portal.

Device-Specific Documents for Bone Cement

Device-specific documents on top of the core set for bone cement:

ISO 5833 test reports — setting time, compressive and bending strength, modulus and exotherm.
Residual-monomer and working-time data.
Biocompatibility (ISO 10993) reports.
Sterilisation validation for powder and liquid components.
Antibiotic drug data (antibiotic cement) — identity, dose, elution profile and stability.
Country-of-origin approval and Free Sale Certificate for imports.

For an import licence (Form MD-14) there are three further essentials:

Free Sale Certificate (FSC) — from the National Regulatory Authority of the country of origin, legalised (apostille/embassy attestation).
Country-of-origin regulatory approval — US FDA 510(k)/PMA, EU CE certificate or equivalent.
Power of Attorney and Authorised Agent licence — notarised, legalised PoA to the Indian Authorised Agent, plus the agent’s valid wholesale/manufacturing licence.

QMS & Essential Principles — What CDSCO Checks

Essential Principles of Safety and Performance (Fifth Schedule) — the device must be safe and perform as intended, with risks reduced as far as possible. Shown through recognised standards and the risk-management file.
Quality Management System (ISO 13485) — design controls, supplier control, process validation, traceability, complaint handling and CAPA, evidenced at audit.
Risk management (ISO 14971) — a living file with residual risks justified and communicated in the IFU.
Clinical evidence — proportionate to the class: clinical evaluation for lower-risk devices and clinical investigation data for many Class C/D and novel devices.

Label & IFU Requirements Specific to Bone Cement

Bone-cement labelling is checked for type, mixing and sterility:

Product name, viscosity/type and whether antibiotic-loaded (with the antibiotic named).
Manufacturer name and address, and the CDSCO licence number.
Batch/lot number, date of manufacture and use-by date.
“STERILE” with the sterilisation-method symbol for each component.
Mixing ratio, working/setting time and handling information in the IFU.

Plain vs Antibiotic-Loaded: the Drug-Device Fork

The pivotal decision for bone cement is whether it carries an antibiotic. Plain PMMA cement is regulated purely as a Class D device on ISO 5833 and biocompatibility evidence. Antibiotic-loaded bone cement is a drug-device combination: the cement is licensed as a device, but the antibiotic brings a drug evaluation — identity, dose, elution kinetics and stability — and can involve the drug wing of CDSCO. Confirm the antibiotic status at the outset, because it changes the dossier, the reviewers and the timeline.

Step-by-Step CDSCO Registration Process for Bone Cement

Confirm the classification. Fix the risk class against the CDSCO classification list and the First Schedule — Class D here — which decides the form, authority, fee and audit route.
Choose the route. Manufacture (Form MD-7 → MD-9) or import (Form MD-14 → MD-15). Importers appoint an Indian Authorised Agent holding a valid manufacturing or wholesale licence.
Build the Device Master File and Plant Master File. Assemble device description, materials, design and process data, the ISO 14971 risk file, sterilisation/stability data and the site file with the QMS.
Complete the Essential Principles checklist. Map the device against each applicable essential principle and cite the BIS/IS or ISO/IEC standard or test report relied on.
Draw the test and performance reports. Test to the applicable standards at an accredited laboratory. Sterile and measuring devices carry additional validation.
Register and file on the CDSCO Medical Device Online portal. Create the account, pay the government fee online and upload the full dossier under the correct form.
Site audit / inspection. A CDSCO joint audit team inspects the manufacturing site before the licensing authority grants the licence — site inspection is mandatory for Class C and D.
Respond to queries and receive the licence. Answer the deficiency letter within the stipulated period. On approval the licence issues in Form MD-9 (manufacture) or MD-15 (import).

CDSCO Registration Fees and Timeline for Bone Cement

The Second Schedule of the Medical Devices Rules sets the fees, and you pay them online through the CDSCO portal. Also, for manufacture of a Class D device the fee is Rs 50,000 per site plus Rs 1,000 for each distinct device, paid to the Central Licensing Authority (CDSCO headquarters). CDSCO charges import fees under Form MD-15 per site and per device in USD — roughly USD 1,000 per site plus USD 50 per device for lower-risk devices, up to about USD 3,000 per site plus USD 1,500 per device for Class C and D. In fact, a test licence (Form MD-13) carries a modest fee. Always confirm the current figure on the CDSCO portal before filing.

Furthermore, a complete Class D manufacturing file typically clears in about six to nine months. An import (MD-15) file usually takes six to nine months. Also, every deficiency letter effectively restarts the clock. Unlike the old registration certificates, an MDR 2017 licence does not expire — it stays valid as long as you pay the retention fee (equal to the licence fee) every five years and meet the conditions of licence.

Common Mistakes That Trigger a CDSCO Query

Class D implant-material files draw detailed queries. Moreover, recurring reasons for bone cement are:

Mechanical (compressive/bending) or setting data short of ISO 5833.
Antibiotic cement filed as a plain device, with no drug dossier.
Residual-monomer or exotherm data missing.
Sterilisation validation absent for one of the components.
Free Sale Certificate scope not covering the product on import.

Related Approvals to Plan Alongside CDSCO

DGFT Importer-Exporter Code — mandatory for any importer of record before the first consignment.
Wholesale / sale licence (Form 20B/21B or Form MD-42) — for stocking and distributing the device. The Indian Authorised Agent for an import licence must already hold one.
Legal Metrology (LMPC) registration — importers of pre-packaged devices declare MRP, net quantity, importer details and country of origin on the pack.
BIS certification — where the device or its electrical components fall under a mandatory BIS/CRS scheme.

Post-Approval Obligations

Print the licence number on the label and keep the Essential Principles conformity current.
Operate a Post-Market Surveillance (PMS) system and file the Periodic Safety Update Report (PSUR) on the schedule for the device’s class.
Report adverse events and field safety corrective actions through the Materiovigilance Programme of India (MvPI) and to CDSCO within the prescribed timelines.
Report any change in device, materials, site, labelling or QMS, and any regulatory action or recall in another country.
Retain distribution records for traceability and allow CDSCO to draw samples and inspect the premises.
Pay the retention fee every five years to keep the licence in force, and track BIS/ISO standard revisions.

FAQs on CDSCO Registration for Bone Cement

What CDSCO class is bone cement?

Bone cement is Class D, so a domestic manufacturer files Form MD-7 for an MD-9 licence with the Central Licensing Authority, and an importer files Form MD-14 for an MD-15 licence.

Which standard applies to bone cement in India?

ISO 5833 for acrylic resin cements (setting, mechanical and exotherm performance), with ISO 10993 biocompatibility and validated sterilisation.

Is antibiotic-loaded cement treated differently?

Yes — antibiotic-loaded bone cement is a drug-device combination, so on top of the Class D device dossier you must provide the antibiotic’s identity, dose, elution and stability.

Does CDSCO require a site inspection?

Yes — for Class D manufacture, a CDSCO joint audit team inspects the site before the licensing authority grants the MD-9 licence.

How long does bone-cement registration take?

Budget roughly six to nine months for a plain cement (MD-9/MD-15). In addition, antibiotic cement takes longer due to the additional drug evaluation.

Does the licence expire?

No — the MDR 2017 licence is perpetual, subject to the five-yearly retention fee and continued compliance.

Why Choose PCN India Global

Classification triage — we confirm the correct risk class for your bone cement against the current CDSCO list before we draft anything.
Route selection — manufacture (MD-5/MD-9) or import (MD-15), with the Indian Authorised Agent arrangement handled.
Dossier build — Device Master File, Plant Master File, Essential Principles checklist and ISO 13485/ISO 14971 readiness.
Standards and testing — the right BIS/IS or ISO/IEC standards mapped and accredited test reports coordinated.
End-to-end online filing — application, audit support, query response and the licence grant managed for you.
Adjacent approvals — DGFT/IEC, LMPC, wholesale/sale licence and BIS coordinated alongside your CDSCO licence.

PCN India Global manages the complete CDSCO process for bone cement — from classification and route selection to Device and Plant Master File preparation, online filing, audit support and the licence grant. Also, whatsapp or call +91 80109 05029, or email admin@pcnindiaglobal.com, to get your registration underway.

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Related CDSCO Registration Guides

Need end-to-end help? See our CDSCO registration services, or read these related guides:

Official references: Central Drugs Standard Control Organisation (CDSCO) and the CDSCO MD Online portal.