Overview of CDSCO Guidelines for Medical Devices
All aspects of medical device regulation in India are administered by the Federal Drug Administration (FDA), who have been granted authority through the Medical Device Regulations (MDR), 2017, under the Drugs and Cosmetics Act of 1940. Therefore, the central purpose of the FDA is to oversee every aspect of the manufacturing, importing, and distributing of all medical devices in India.
Over the past few years, from 2021 to 2024, the FDA has introduced additional medical devices to the list of regulated products, as well as numerous regulatory documents. These documents guide the classification of medical devices, stability testing, clinical investigation, post-marketing surveillance and performance evaluation. All manufacturers, importers and distributors will need to comply with the MDR 2017, any applicable FDA notifications and any additional guidelines that are issued, in order to continue to sell medical devices in India after January 1, 2025.
What are Medical Devices Under CDSCO?
As defined by the MDR 2017 Directive, A medical device refers to an instrument, apparatus, software, implant, material, reagent or similar article which is intended for diagnosis, treatment, modification and/or diagnosis of disease/condition. Other types of medical devices are thosethath provide information regarding medical use via in vitro examinations of body fluids.
Government notification is required before any medical device can be regulated. As of 2024-25, almost all medical device categories have now undergone notification and regulation by the government.
Classification of Medical Devices Under MDR 2017
The classification system used by CDSCO is based on risk and aligns closely with the three classifications previously established by IMDRF and the classifications used by the EU GHTF. The classification system contains four classes:
Class A - Low Risk
Some Examples: Thermometers, reusable surgical instruments, simple wound care products.
Class B - Low-Moderate Risk
Some Examples: Needles, suction equipment, nebulisers, anaesthesia tubing.
Class C - Moderate-High Risk
Some Examples: Dialysis equipment, infusion pumps, ventilators, orthopaedic implants.
Class D - High Risk
Some Examples: Pacemakers, heart valves, implantable defibrillators, and blood bags to be used for transfusion.
The classification determines the regulatory path followed by the manufacturer, documentation requirements, technical requirements, study requirements and approval timelines. The classification list published by CDSCO is constantly updated, so manufacturers must ensure they refer to the most(current) up-to-date version whenever they are performing their device registration in the CDSCO.
Types of CDSCO Licenses for Medical Devices
Depending on the type of applicant and the category of product, CDSCO issues different types of licenses as per MDR 2017. The following are examples of licenses that CDSCO may issue as per MDR 2017:
Manufacturing License
- Manufacturing License for Class A & Class B
- Manufacturing License for Class C & Class D
Import License
- Import License for All Classes of Medical Devices
- Permission to Import for Clinical Investigation / Investigational Devices
Loan License
- Manufacturers who have access to another facility to manufacture their product use Form MD-6 / MD-10.
Clinical Investigation Permit
- Permit to conduct Clinical Investigation on Class C and Class D new devices.
Test License
- For Research & Development, Clinical Investigation, Examination, and Testing of Medical Devices.
Registration with a Notified Body’s Certification for Class A/B Manufacturer
- Class A or B Manufacturer may need to have their Quality Management System certified by a Notified Body before receiving a License from the State Licensing Authority.
Key CDSCO Guidelines for Medical Devices
The CDSCO (Central Drugs Standard Control Organisation) has released a series of guidance documents which apply to the manufacturers and the importers, such as:
1. Guidelines on Risk-Based Classification of Medical Devices
This is to assist the applicant in determining the risk to use, classifying the devices according to their intended use and risk classification and class.
2. Guidelines on Clinical Investigation of Medical Devices
This is to guide manufacturers of class C and class D devices on the protocols to be followed, the ethical approval process for clinical investigations and the necessary requirements to conduct a clinical investigation in accordance with the ISO 14155 guidelines.
3. Guidelines on Stability Testing (2023–2024)
This guideline is mandatory for devices with sterility, shelf-life and packaging integrity.
4. Guidelines of Post Market Surveillance and Materiovigilance
Manufacturers of devices must establish an adverse event reporting system and report vigilance through vigilance reports.
5. Guidelines on Import and Registration Requirements
These guidelines give manufacturers information to compile their device master files (DMF), plant master files (PMF), quality management systems (QMS) documentation and labelling requirements.
6. Guidance on Performance Evaluation of Diagnostic Devices (if applicable)
These guidelines are required for IVD devices and their corresponding analysers.
7. Guidelines for Inspection and Verification at the Ports of Entry
CDSCO can randomly sample, conduct port inspections and enforce compliance before the release of the consignment.
8. Guidelines for Change Management and Post-Approval Modifications
These guidelines apply to changes to the design, raw materials, manufacturing location, QMS changes or labelling of the product.
In addition to the above guidelines, the guidelines must be adhered to in conjunction with all the requirements of the Medical Device Regulation of 2017.
CDSCO Registration Documents for Medical Devices
Although all classes of documents will include a different set of documents, each has a core set of documents, which are:
General Documents
Application Form (MD-14, MD-5, MD-9)
Cover Letter
Fee Challan Payment Receipt
Power of Attorney (for importers)
Free Sale Certificate (or Market Authorisation - if it applies)
Technical Documents (DMF & PMF)
Device Description
Intended Use
Design and Manufacturing Process
Raw Materials and Specifications
Biocompatibility Reports, as applicable
Sterilisation Validation (if applicable)
Electrical Safety Standards (IEC 60601 Series as applicable)
Software Validation (IEC 62304 - as applicable)
Risk Analysis (ISO 14971)
Quality System Documents
ISO 13485 Certification
QMS Procedures
Supplier Management & Validation Reports
Internal Audit & CAPA Records
Performance and Safety Data
Bench Studies
Clinical Investigation Data (for Class C and D new devices)
Pre-Clinical Test Reports
Stability Studies
Labelling and Packaging
Artwork Proofs
IFU/User Manual
Evidence of Shelf-Life and Storage Conditions
Other Certification
CE certificate (or US FDA Clearance - if applicable)
Declaration of Conformity
Undertakings Required for MDR 2017
CDSCO Registration Process for Medical Devices
1. Determine Classification
Identify the appropriate classification from A-D as defined by MDR 2017 and the CDSCO (the Central Drugs and Standards Organisation of India) classification issued most recently.
2. Determine Appropriate License Type
The type of license you will require for your product is based on whether you will be manufacturing, importing, have an existing license or are preparing to conduct a clinical trial.
3. Prepare Technical Documents
Technical documents for your product should include, but are not limited to: Drug Master File (DMF), Product Master File (PMF), Quality Management System (QMS) evidence, risk analysis and clinical/performance data.
4. Apply through CDSCO’s Online Portal (SUGAM)
The application requires completed forms MD-5, MD-9, MD-14, and other relevant forms and documentation, as well as the appropriate fees, to be submitted via the online portal.
5. Review by CDSCO
During the review process, CDSCO may request that you provide corrections, clarifications, additional data, or perform testing (either by submitting additional samples or performing a Good Manufacturing Practice [GMP] audit).
6. Notified Body Audit
All manufacturers of Class A and B products must undergo an audit by the notified body (QMS) before obtaining a manufacturing license from the state licensing authority.
7. Site Inspection
When issuing a license for Classes C and D, CDSCO will usually perform a plant inspection to ensure compliance with QMS and GMP.
8. Issue of License
Upon completion of the review and inspection, CDSCO will issue a manufacturing/importation license.
9. Compliance Post-Licensing
Post-licensing obligations will consist of the following items that must be reported to CDSCO: product market surveillance (PMS) and safety/adverse event reports, recalls, notification of changes, quality audits, updated labels and renewals/periodic submissions.
Conclusion
The Indian Government has established a regulatory framework regarding the medical device industry. The Indian Government has established a risk-based oversight program to monitor the approval of medical devices. In 2023, the Indian Government has adopted a risk-based approach to monitor the medical device industry and to establish a risk-management framework that aligns with the international standards for medical devices.
To obtain or maintain access to the marketplace in India, the manufacturer or importer of the medical device must comply with the following:
Classify the device appropriately.
Create extensive and complete technical documentation;
Implement an ISO 13485-based quality management system;
Consistently adhere to CDSCO guidance documents; and
Once your license is granted, maintain continued compliance. A thoroughly developed regulatory strategy reduces the possibility of unintentional delays and helps the CDSCO expedite approval of your application.
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