CDSCO Certification for General Hospital Medical Devices

UMSPCS provides CDSCO certification and regulatory approval support for general hospital medical devices in India, including compliance and documentation.

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General Hospital Compliance Made Simple: A Guide to CDSCO Certification

While hospitals may have good infrastructure with experienced doctors and advanced treatment facilities, when medical devices come into the equation, compliance with regulations is as significant as the performance of those devices.

Various products can be used in a general hospital, which can come under the purview of regulation of medical devices in India. The Central Drugs Standard Control Organisation (CDSCO), an organization under the Ministry of Health & Family Welfare, regulates medical devices under the Drugs & Cosmetics Act, 1940 and the Medical Devices Rules, 2017 (MDR 2017).

The CDSCO has particularly issued a classification list for Medical Devices Pertaining to General Hospital Instruments. So, the regulatory requirement will be related to the medical device itself, its classification, and the activity being performed on it, whether it is manufacturing, importing, selling, or distributing it.

What Does CDSCO Certification for General Hospital Actually Mean?

The phrase CDSCO Certification for General Hospital is frequently used when talking about regulations of medical devices that would be used in a general hospital.

According to MDR 2017 definition, a medical device comprises instruments, apparatus, appliances, implants, materials, software and accessories intended for a particular purpose which relates to the diagnosis, prevention, monitoring, treatment, alleviation of disease, injury, disability, or for supporting or maintaining life, for disinfection of medical devices, for providing information for diagnostic or therapeutic purposes and for contraception.

CDSCO categorizes medical devices based on risk:

Risk Class	Risk Level
Class A	Low Risk
Class B	Low-Moderate Risk
Class C	Moderate-High Risk
Class D	High Risk

The classification of each device depends on its purpose and the classification criteria. So, it does not provide sufficient information for the classification to define the device merely as “hospital equipment”.

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Closer Look at Medical Devices Covered Under the General Hospital Classification

A specific notification on the classification of Medical Devices Related To General Hospital Instruments was issued by CDSCO. The list contains a number of diverse devices that are intended for use in hospitals and are assigned various risk classes.

Examples are the following:

Liquid crystal forehead temperature strips
Bed exit and fall prevention monitors
Monitors for electronic monitoring of gravity flow infusion systems
Spinal fluid pressure monitors and manometers
Scales for patients and stand-on
Indicators for biological and physical sterilization processes
Clinical colour change thermometers
Apgar timers
Hydraulic adjustable hospital beds
Paediatric medical cribs
Medical bassinets
Non-powered flotation therapy mattresses
Therapeutic medical binders
Burn sheets
Pressure infusors for IV bags
Automated air removal systems for intravascular administration sets
Patient lifts
Medical examination lights
UV environmental disinfection systems
Vacuum-powered body fluid suction system
Sterilization wraps
Ethylene oxide gas sterilizers
Dry heat sterilizers
Steam sterilizers
Medical washers and washer-disinfectors
Hydrogen peroxide gas plasma sterilization systems
Blood bank centrifuges
Blood storage refrigerators
Heat sealing devices
Stretchers and other patient transportation equipment
Vein locators
Other general hospital and orthopaedic devices

This is just an indicative list. The actual classification document issued by CDSCO includes a much more extensive list, and the relevant classification has to be verified based on the specific product and its intended application.

General Hospital Medical Devices Covered Under CDSCO Classification

CDSCO Classification of Medical Devices about General Hospital Instruments is an extensive list of products used in patient treatment, monitoring, sterilization, surgery, orthopedics, and support operations in hospitals. The document states the device name, its use, and the risk category. Thus, it serves as an essential source to define the regulatory path for a certain product.

Some of the most important examples are as follows:

S. No.	Device Name	Intended Use	Risk Class
1	Liquid crystal forehead temperature strip	A liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever, or to monitor body temperature changes.	B
2	Bed exit monitor, Fall prevention	Intended to be placed under the mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.	A
3	Electronic monitor for gravity flow infusion systems	Intended to electronically monitor the amount of fluid being infused into a patient.	C
4	Electrically powered spinal fluid pressure monitor	Intended to measure spinal fluid pressure by the use of a transducer which converts spinal fluid pressure into an electrical signal.	B
5	Spinal fluid manometer	A spinal fluid manometer is a device used to measure spinal fluid pressure using a needle and graduated column.	B
6	Stand-on patient scale	Intended for medical purposes that is used to weigh a patient who can stand on the scale platform.	A
7	Patient scale	A patient scale is a device intended for medical purposes that is used to measure the weight of a patient who cannot stand on a scale by placing the scale under a bed or chair to weigh both the support and the patient.	A
8	Sterilization process indicator (Biological)	A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization on a medical device.	B
9	Sterilization process indicator (Physical/chemical)	A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process on a medical device.	B
10	Clinical color change thermometer.	A clinical color change thermometer is a disposable device used to measure a patient's oral, rectal, or axillary (armpit) body temperature.	A

Key Compliance Requirements for CDSCO Medical Devices

The regulatory clearance process is not restricted to submission of the application through the online portal alone. It needs to establish that the product complies with the relevant safety, quality, and performance requirements.

The major compliance areas include:

1. Proper Classification of the Device

The device shall be classified based on intended use and appropriate risk-based classification principles.

2. Essential Principles of Safety and Performance

CDSCO guidelines include Essential Principles related to various aspects of:

Chemical, physical and biological characteristics
Infection and micro-biological contamination
Manufacturing and environmental aspects
Medical device containing medicines
Biomaterials
Diagnosis and measurement
Software
Active medical devices
Protection from radiation hazards
Mechanical risks
Protection from risks due to energy or substance
Labelling and user instructions
Performance evaluation
Clinical evaluation, when applicable

3. Quality Management System

Medical Devices Rules, 2017 - Quality Management System provisions deal with various activities like design and development, manufacture, packaging, labelling, testing, installation, servicing, etc.

4. Technical Documentation

Based on the type of regulatory pathway, the applicant may have to provide various technical documents such as device specification, risk management documentation, verification, labelling and user instructions, clinical/performance data etc.

5. Testing and Evaluation

In the case of relevant devices, the testing process needs to take place via laboratories recognised through the regulatory system. Information about the testing laboratories for medical devices is also available at CDSCO.

Applicable Tests for General Hospital Medical Devices

Testing is not the same for all hospital devices. Testing is done according to the characteristics, usage, technology, risk classification, and relevant standards of the device.

For some products, testing requirements can be as follows:

Electric safety testing
EMC testing
Mechanical safety testing
Performance testing
Accuracy and measurements testing
Sterility testing
Microbiological testing
Biocompatibility testing
Chemical testing
Package and stability testing
Software Verification & Validation
Cleaning and disinfection validation
Sterilization validation
Clinical Evaluation Evaluation if applicable

For instance, a steam sterilizer will require completely different data compared to a patient scale, whereas a powered monitor may require electric safety and EMC testing that is not needed in the case of a manual hospital bed.

That is why CDSCO Medical Device Testing Requirements should be identified after profiling of the products.

What Are the Basic Eligibility Requirements?

Before embarking on the CDSCO Certification in India procedure, candidates need to ensure that:

The product is regarded as a medical device
The use of the product is defined
The appropriate risk classification has been determined
The applicant is legally authorized to carry out the planned operation
The manufacturing premises comply with the relevant criteria
Quality Management System requirements have been put in place
Technical documentation is available
Testing and validation are done
The labeling and Instructions for Use comply with relevant criteria
The applicant is able to submit the necessary regulatory documents for the particular application

For Class A and B manufacturing applications, MDR 2017 specifically requires a statement regarding adherence to Quality Management System requirements under the Fifth Schedule.

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End-to-end CDSCO Certification Process for General Hospital Medical Devices

Step 1: Classify the Medical Device

Classification of the medical device used in general hospitals is the first step, according to the Medical Devices Rules, 2017.
Points to Be Considered:

Identification of the appropriate risk class - Class A, B, C, or D

Intended use and purpose of the device

Regulatory requirements related to the device

CDSCO classification verification

Step 2: Preparation of the Documentation

The second step is preparation of the documents that need to be submitted as part of the CDSCO Certification for Medical Devices Application.
Key Documents That Could Be Needed Are As Follows:

Device Master File (DMF)

Plant / Site Master File (PMF/SMF), if any

ISO 13485 Certificate

Technical specifications of the product

Test report, if any

Risk management documents

Labels / Artwork of the product

Instruction For Use (IFU)

Manufacturer and applicant details

Step 3: Prepare the CDSCO Application

Next comes the step of application compilation with all details of the applicant, the manufacturer, and the medical device.
Important Points to Consider:

Filling of the CDSCO application form

Name of the product, its specifications, and intended use

Details of manufacturer and manufacturing site

Details of risk classification

Upload of the documents

Consistency of the technical and regulatory documents

Step 4: Filing of Application Online

Having completed the process of application filing and document preparation, the CDSCO application is filed through the designated online system of CDSCO along with payment of required government fees.
Important Points to Consider:

Upload of documents

Government fee payment

Filing of the application online

Checking of the application for completeness

Step 5: CDSCO Scrutiny and Regulatory Assessment

The application is then subjected to review by the concerned authority. It might conduct a review of technical data, test data, manufacturing data, among other information that is available with the application. Depending on the product and the pathway of regulation, there may be a need for further information, clarification, or even inspection.
Key Issues:

Review and verification of documents that have been submitted

Evaluation of the technical and regulatory information

Answering any deficiency questions raised by CDSCO

Inspection or audit of facility if applicable

Further submission of information as per requirement

Step 6: Issue of CDSCO Licence

When the application passes all the regulatory requirements, the concerned CDSCO licence will then be issued.
This will depend on the activity that one wishes to pursue, like manufacturing or importing the device.
Important Issues:

Issue of CDSCO licence as per the activity

Authorization for manufacturing or import

Meeting any other applicable post-approval regulations

Maintenance of technical and regulatory information

Ongoing compliance with the Medical Devices Rules, 2017

Essential Documents for CDSCO Certification

The actual documentation would depend on whether the applicant is a manufacturer, an importer, or other such regulated party, and also on the risk classification of the device.

A common technical and regulatory documentation would comprise:

Form MD 40
TR6 Challan
Power of Attorney
Device Master File
Covering letter
Plant Master File
Quality Assurance certificate
Conformity declaration
Covering letter
Certificate of Incorporation
Approvals documents

Whereas the MDR 2017 prescribes documentation through its schedules, the regulatory pathway from CDSCO prescribes the requirements for the Plant master file and device master file.

CDSCO Certification Cost for General Hospital Medical Devices

However, there is no static rate that is charged for CDSCO Certification of General Hospital products.

The cost can comprise:

Cost Component	Depends On
Government fee	Device class and application type
Product testing	Device type and applicable tests
Laboratory charges	Tests and laboratory selected
Clinical evaluation	Whether applicable
Documentation	Complexity of technical file
Inspection/audit	Whether applicable
Consultancy	Scope of professional support
Import-related compliance	Manufacturer, product and regulatory route

There are government charges that are laid out in the Second Schedule of the Medical Devices Rules, 2017, and not through a single certificate charge.

Hence, it would be incorrect to quote a static amount for every general hospital medical device by any consultant without analyzing the product.

How Long Does CDSCO Certification Take?

The timeline will differ greatly among the various products. The issues that could affect the timeline include:

Classification of the product
Availability of the documents
Testing procedures
Laboratory testing period

Stage	Estimated Timeline
Product Classification	2 - 5 Working Days
Documentation Preparation	1 - 3 Weeks
Application Submission	2 - 5 Working Days
CDSCO Review & Query Handling	Varies depending on product complexity
Grant of Registration/License	Subject to successful regulatory review

Nevertheless, the above timeline cannot be generalized as the timeline for all CDSCO medical device applications.

In UMSPCS, the expected timeline will be determined after the above factors are considered.

Why Choose UMSPCS for CDSCO Certification?

Seeking CDSCO certification in India might require several technical and regulatory processes. We help organizations navigate through this process in an organized manner rather than taking it lightly and considering it just as filling out forms.

With 600+ products in compliance and 6+ years of experience, UMSPCS is committed to helping manufacturers, importers and businesses simplify their compliance requirements when venturing into India’s regulated market.

Support Provided by Us Includes:

Product profiling and regulatory assessment
CDSCO medical device classification
Determining suitable regulatory route
Documentation gap assessment
Technical document creation assistance
Arranging for suitable product testing
Application filing and preparation support
Answering regulatory queries
Importation documentation assistance
Manufacturing compliance assistance
Post-approval regulatory assistance

Conclusion

Compliance for a medical device is more than just about getting a certificate; it is all about ensuring that the product complies with the appropriate regulations, safety and quality requirements.

If you are an Indian manufacturer, foreign manufacturer, importer, medical supply company or a businessman dealing with medical devices meant for use in general hospitals, then the first thing you need to do is know what regulatory pathway your product needs to follow.

UMSPCS will take care of all your questions regarding how to proceed further with product specific assessment and compliance for your products.

Looking for CDSCO Certification for General Hospital medical devices?

Contact us at UMSPCS and get your product assessed before starting the process of application. Also get to know more information about CDSCO Certification for Urological Medical Devices.

Frequently Asked Questions (FAQs)

This would generally refer to CDSCO compliance for medical devices falling within the General Hospital Instruments Category. There is no one blanket certificate granted to every general hospital.

No, CDSCO requirements are generally applicable to medical devices and activities like manufacturing, importation, sale or distribution of medical devices.

The products may include hospital bed, patient scales, sterilizers, examination lights, suction apparatus, blood-bank apparatus, patient transport apparatus, disinfecting apparatus and many more medical devices.

Classification of medical devices takes place into Class A, B, C and D on the basis of risk under MDR 2017.

The documents may include technical specification, device master documentation, test report, risk management information, QMS documents, label, IFU and many other regulatory documents.

The requirement for testing depends upon the device, its classification, standards, and regulatory route. No single testing can be performed for all devices.

The cost is based upon classification, government charges, testing, documentation, inspection, and consulting services. The product can be evaluated and an estimated cost can be provided.

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CDSCO Certification for General Hospital Medical Devices