Medical devices used by healthcare professionals to administer treatment and provide patient care fall under general hospital medical devices category. These are basic common medical devices required to provide treatments planned in the hospital. Additionally, general hospital medical devices include devices required to cater to the medical needs of the community. Moreover, these devices are required both in general hospitals as well as secondary care units. Central Drugs Standard Control Organisation (CDSCO) is the apex regulatory body for all medical devices entering the Indian healthcare industry. As general hospital medical devices have a crucial role in the daily functioning of a hospital, they have to be strictly regulated. Therefore, securing the CDSCO general hospital medical devices license is a mandatory requirement.

The CDSCO aims to ensure high-quality, safe, and effective general hospital medical devices are available in the Indian medical device market. By preventing the entry of substandard medical devices in the Indian market, CDSCO aims to fulfil its vision of making India a global medical device hub. Hence, medical device manufacturers and importers are required to abide by the CDSCO regulatory guidelines. Furthermore, the manufacturing process should be at par with the standards set by CDSCO to ensure the finished products meet international quality benchmarks. In this blog, we will dive into the CDSCO license application process for general hospital medical devices.

CDSCO general hospital medical devices license application process

Securing the CDSCO general hospital medical devices license is mandatory to launch your devices in India. To manufacture general hospital medical devices in India, you have to secure the CDSCO medical device manufacturing license. In contrast, to import general hospital medical devices into India, you have to secure the CDSCO medical device import license. To secure these licenses, you have to abide by the CDSCO regulatory guidelines. Moreover, an understanding of the CDSCO medical device classification system is required to proceed with the CDSCO license application process.

Understanding the CDSCO general hospital medical device classification system

Based on the risk level associated with their intended use, the CDSCO has classified medical devices into four classes. The classes in increasing order of risk level are A, B, C, and D. This CDSCO medical device classification system has been developed to ease out the medical device license application process. Moreover, specific application processes and licenses are applicable for specific CDSCO medical device classes. To check which class your medical device belongs to, you can use our free tool.

CDSCO general hospital medical device classes

We have listed few examples of general hospital devices belonging to the different CDSCO classes.

CDSCO class A

• Bed exit monitor, Fall prevention
• Stand-on patient scale
• Patient scale
• Clinical color change thermometer
• Apgar timer
• Hydraulic adjustable hospital bed.
• Manual adjustable hospital bed.
• Nonpowered flotation therapy mattress.
• Therapeutic medical binder
• Burn sheet
• Neonatal eye pad
• Therapeutic scrotal support
• Umbilical occlusion device
• Cardiopulmonary resuscitation board
• Blood grouping slides
• Blood bank pipettes
• Blood mixing and blood weighing devices
• Blood bank centrifuge
• Hand-carried stretcher

Class B

• Liquid crystal forehead temperature strip
• Electrically powered spinal fluid pressure monitor
• Spinal fluid manometer
• Sterilization process indicator (Biological)
• Sterilization process indicator (Physical/chemical)
• Clinical electronic thermometer
• Clinical mercury thermometer
• Medical bassinet
• Pediatric medical crib
• Pressure infusor for an I.V. bag.
• Intravascular administration set, automated air removal system
• Patient care reverse isolation chamber
• Blood Vacutainer

CDSCO class C

• Electronic monitor for gravity flow infusion systems
• Infant radiant warmer
• Jet lavage
• Neonatal incubator
• Neonatal transport incubator
• Chemical cold pack snakebite kit
• Ethylene oxide gas sterilizer
• Dry-heat sterilizer
• Steam sterilizer
• Liquid chemical sterilants/high level disinfectants
• Medical washer-disinfector
• Hydrogen Peroxide Gas Plasma Sterilization System
• Wheeled stretcher

Documents required for securing the CDSCO general hospital medical devices license

We have listed the documents required to apply for the CDSCO general hospital medical devices license.

1. Organization identity proof
2. Sale Deed/Rent Deed of the Premises
3. Building Layout with Dimension
4. Documents for the team of qualified and experienced staff who can manufacture and test your medical devices.
5. Device Master File
6. Plant Master File
7. ISO 13485 Certificate
8. Test License, if required for testing the general hospital medical device
9. Environmental regulation compliance documents
10. Certificate of analysis of 3 consecutive batches

We have provided an overview of the documents required. For a detailed list of documents, feel free to contact us. Furthermore, we have extensive expertise in CDSCO document preparation. Our team of experts will help you prepare and compile the documents as per CDSCO guidelines.

CDSCO general hospital medical devices license types

• Importing general hospital medical equipment into India: MD 15 Import License has to be secured from the CDSCO to import general hospital medical equipment into India.
• Manufacturing class A and B general hospital devices: MD 5 License will be required to manufacture class A and B general hospital devices. Moreover, a fee of Rs. 5,000 for the manufacturing license is required. Additionally, Rs. 500 for each distinct device is required. The license has to be obtained from the state licensing authority.
• Manufacturing class C and D general hospital devices: MD 9 License  will be required to manufacture class C and D general hospital devices. Moreover, a fee of Rs. 50,000 for the manufacturing license is required. Additionally, Rs. 1,000 for each distinct device is required. The license has to be obtained from the central licensing authority.

CDSCO general hospital medical devices license validity

The CDSCO general hospital medical devices license is valid indefinitely. However, the license retention fee has to be paid every 5 years to maintain the license validity.

A step-by-step guide of the CDSCO general hospital medical devices license application process

The CDSCO license application process for general hospital medical devices involves the following steps:

• Check CDSCO Class: The first step while applying for CDSCO medical device license is to check which class your medical device belongs to.
• Document preparation: Compile all necessary documents, including clinical trial data and product specifications. All supporting documents have to be meticulously prepared.
• Application Submission: File the application online on CDSCO’s official online portal. Additionally, upload all the necessary documents.
• Query Resolution: CDSCO may raise queries that have to be promptly and accurately addressed.
• Inspection: Prepare for the CDSCO medical device facility inspection and audit phase. The regulatory officials may visit the medical device facility to carryout inspection.
• License Approval: Once all the criteria are satisfied, CDSCO will grant the medical device license.

Common CDSCO license application challenges and how to overcome them

Manufacturers and importers might face the following challenges while applying for their CDSCO license. Hence, we have provided some tips on how to overcome them.

• Documentation Gaps: Ensuring all documents are up-to-date and meet CDSCO’s requirements.
• Delays in Query Resolution: Setting up a dedicated team to address CDSCO queries promptly.
• Inspection Hurdles: Regular internal reviews of facilities to ensure they meet CDSCO guidelines.

Pharmadocx Consultants: Your trusted regulatory support

We offer comprehensive services to support medical device manufacturers and importers.

• Expert Guidance: Assistance throughout the CDSCO medical device registration process.
• Mock Audits: Conducting pre-inspection audits to ensure readiness.
• Query Resolution: Our team will help you promptly address CDSCO queries.
• End-to-End Support: Comprehensive support from the initial application to license approval. We will provide support till you successfully secure the CDSCO medical device license.
• Learn More

Mandatory CDSCO medical device license requirement ensures that healthcare professionals are equipped with the best tools for patient care. Moreover, compliance with CDSCO regulatory guidelines is a testament of the manufacturer’s dedication to patient safety and product quality. Furthermore, staying compliant ensures trust in the brand and helps avoid potential regulatory repercussions. Are you planning to apply for CDSCO general hospital medical license? Drop an email at [email protected] or call/Whatsapp on 9996859227 to let us help you.