CDSCO Medical Device Registration- An Overview

If you are engaged in the medical devices business in India, obtaining CDSCO medical device registration is mandatory. For expert guidance on the registration process, connect with the CDSCO Medical Device registration consultants at Fastzeal.

The Central Drugs Standard Control Organization (CDSCO) is India’s regulatory authority responsible for the approval, registration, and oversight of pharmaceuticals, medical devices, and other health-related products.

India's healthcare industry, valued at $200 billion in 2023, is projected to grow to $370 billion by 2025. With over 900 pharmaceutical manufacturers, India is the 4th largest producer of pharmaceuticals globally. Under the supervision of the Drug Controller General of India, the CDSCO regulates this dynamic industry.

Earlier, only 15 categories of medical devices were regulated, leaving much of the market unregulated and dominated by global med-tech companies. However, the introduction of uniform standards has elevated Indian medical equipment to meet global quality benchmarks.

Talk to our CDSCO medical device license consultants for effortless registration.

CDSCO Medical Device Manufacturing License

In India, any medical device manufacturer must obtain a CDSCO Medical Device Manufacturing license. As such, medical devices that are cover under class A and B, the manufacturing licenses will be issued from the State Licensing Authority.

On the other hand, medical devices under category C and D the manufacturing licenses shall be issued from the Central Licensing Authority.

Benefits of CDSCO Medical Device Registration in India

Manufacturers and importers of medical devices looking to enter the Indian market are required to obtain CDSCO medical device registration. Below are the key benefits of securing CDSCO registration:

• Access to Market: This allows the manufacturers or importers of medical devices to sell and distribute their products in the Indian market, one of the largest pharmaceutical and medical device markets in the world.
• Brand Recognition: It facilitates brand recognition by enhancing its credibility as it demonstrates that the products have met the rigorous safety, efficacy, and quality standards as per the CDSCO regulations.
• Regulatory Compliance: CDSCO medical device registration ensures that the manufacturers have complied with the Indian regulatory requirements including GMP and MDR.
• Competitive Advantage: It also provides a competitive advantage as prior CDSCO registration enables manufacturers to participate in tenders and procurements issued by governments and various other private institutions.

Who can Apply for CDSCO Medical Device Registration in India?

The given below are the entities or individuals who can apply for CDSCO medical device registration in India:

• Domestic manufacturers of Medical Devices and IVDs
• Importer of Medical Devices/IVDs/Cosmetics
• Foreign Manufacturers of Medical Devices and IVDs
• Authorized Agent of Medical Devices and IVDs
• Indian Subsidiary of Medical Devices and IVDs

Requirements for CDSCO Medical Device Registration in India

The requirements for CDSCO medical device registration in India are as follows:

• Compliance with Indian laws and regulations
• Manufacturing facilities details
• Regulatory Certificates such as European CE, Free sale certificate, ISO 13485, etc.
• Labelling and Packaging requirements
• CDSCO registration fees

Documents Required for Medical Device Registration

The list of documents required for medical device registration is as follows:

• Form 40
• ISO 13485 Certificate
• Full Quality Assurance Certificate
• CE Design Certificate
• Undertaking of information being authentic and genuine
• Free sale certificate or certificate from the foreign government
• Certificate of marketability from GHTF
• Plan Master Report
• Device Master File
• PMS Surveillance
• Fee Challan
• Test Protocol

How to Apply for CDSCO Registration for Medical Devices?

Here, given below is a step-by-step guide that will help you understand the process to apply for CDSCO registration for medical devices:

• Step 1: Classification of Medical Devices: The applicant must first determine the correct classification of the medical device before proceeding with the application. The application should include comprehensive details about the drug or medical device, such as its composition, formulation, manufacturing process, required regulatory certificates, and intended use. If available, the application should also include relevant clinical trial data.
• Step 2: Application Submission: Once the application is prepared, it must be submitted online through the CDSCO portal, along with the required fees for medical device registration in India. The CDSCO will then review the submitted application and may request additional information if further clarification is needed.
• Step 3: CDSCO Review: Upon receiving the application, the CDSCO will review it to assess whether the drug or medical device is safe and effective for use. This review process involves evaluating all relevant data, conducting site inspections, and consulting with experts in the respective field.
• Step 4: Approval or Rejection: Based on its evaluation, the CDSCO may approve the drug or medical device for sale and distribution in India. However, if the drug or medical device fails to meet the required safety and efficacy standards outlined in the regulations, the CDSCO may reject the application for medical device registration.
  
  

  Classification of Medical Devices under CDSCO Regulations

  The Central Drugs Standard Control Organization (CDSCO) in India has classified medical devices into four classifications as given below:

  Class A Medical Devices: Class A medical devices are low-risk devices, such as stethoscopes, bandages, and basic medical instruments. These devices have minimal potential to harm patients or users.

  Class B Medical Devices: Class B medical devices are low to moderate-risk devices, including blood pressure monitors, syringes, and needles. While malfunctions could cause harm, the risk is not life-threatening.

  Class C Medical Devices: Class C medical devices fall under the moderate to high-risk category, such as artificial heart valves, orthopedic implants, and catheters. Malfunctions in these devices could result in serious harm or injury to patients.

  Class D Medical Devices: Class D devices are high-risk medical devices, including pacemakers, heart-lung machines, and ventilators. These devices are critical for patient health and survival, and malfunctions could lead to severe harm or even death.

  CDSCO Forms for Registration of Existing Medical Devices

  The list of CDSCO forms for registration of existing medical devices is as follows:

  Application MD-14 Permission:MD-15: This is for importers for a medical device category A, B, C, D for applying importer license

  Application MD-3 permission:MD-5: Manufacturers for medical device categories A and B must apply under this CDSCO form to obtain a manufacturing license in India.

  Application MD-4 Permission:MD-6: This form is for manufacturers who want a CDSCO loan license in India.

  Application: MD-7 Permission: MD-9: This form is for manufacturing licenses for the medical device category under C and D.

  Application: MD-8 Permission: MD-10: This form is for a manufacturer who wants a CDSCO loan license in India.

  CDSCO Forms for Registration of New Medical Devices

  Application MD-22 Permission MD-23: This application is for importers for medical device categories A, B, C, and D for clinical investigation permission.

  Application MD-26 Permission MD-27: This application is for importers of medical device categories A,B,C,D for an import license.

  Application MD-16 Permission MD-17: This application is applicable to categories A, B, C, D for a test license.

Renewal of CDSCO Medical Device Manufacturing License

As per the Central Drugs Standard Control Organization (CDSCO), the medical device manufacturing license must be renewed at least nine months before the expiration of the registration certificate.

While no additional documents are required for the renewal of CDSCO medical device manufacturing license, the certificate holder shall submit a copy of the Plant Master File (PMP) and Device Master File (DMF) to confirm that no changes have been made.

Post Compliance Medical Device Registration Online

Some of the important post compliance after obtaining medical device registration online are as follows:

• It is to be informed by the concerned manufacturer and authorized representative of the importer to the concerned licensing authority in case there arises a change in the constitution of the firm or the address of the registered office or factory premises.
• If any changes occur in the existing CDSCO medical device registration certificate, it will remain valid for three months from the date of the change. During this period, the manufacturer or authorized representative must apply for and obtain a new CDSCO medical device registration.

Recent CDSCO Update

As per the new updates from the Central Drugs Standard Control Organization (CDSCO) all medical devices now require a mandatory registration for import and sale in India that shall be effective from October 1, 2023.

Fees for CDSCO Medical Device Registration

The government fees for CDSCO medical device registration are specified into several categories depending upon the type of license and classification of medical devices.

The CDSCO Medical Device Manufacturing License Fees, for device class A and Class B, the governmental fee is INR 5000/-(one site) and INR 1000/- (for each distinct medical device). For class C and D medical devices, the governmental fee is INR 50000 (one site), and INR 1000 (for each distinct medical device).

Timeframe for Obtaining CDSCO Medical Device Registration

The timeframe for obtaining CDSCO medical device registration takes around six to nine months. Meanwhile, the validity period of CDSCO medical device registration is three years from the date of issue of registration unless it is revoked or suspended by the concerned authority with a relevant cause.

Offerings by our CDSCO Medical Device License Consultants

Have a look at the key offerings by our CDSCO medical device license consultants-

• Medical Device Classification and Grouping Strategy in India
• Regulatory Intelligence and Due Diligence Services in India
• Indian Authorized Agent (IAA) Representation
• Listing of Non-regulated Medical Devices
• SUGAM Account Creation and Account Management
• Manufacturing License for Regulated Medical Devices and IVDs
• Loan License for Regulated Medical Devices and IVDs
• Liaison with the CDSCO, Central, and State Licensing Authorities
• In-country Testing Services
• Manufacturing Site Registration
• Test License for Medical Devices and IVDs
• Post-market Surveillance
• AERB Approval for Radiation Diagnostic Services

Why Pick Fastzeal for CDSCO Registration for Medical Devices?

Fastzeal, a leading CDSCO Medical Device License Consultant, offers comprehensive services to streamline the CDSCO medical device registration process, ensuring compliance with Indian regulatory standards.

Given below are the reasons why entrepreneurs in the medical device industry partner with us for CDSCO registration for medical devices-

• 10+ Years of Expertise in the Space of CDSCO Registration for Medical Devices
• Facilitating Timely Approval for CDSCO Medical Device Registration Online
• Expert Guidance to Clients in Accurately Classifying Devices
• Successfully Registered Medical Devices for 100+ Clients
• First Choice of Top Medtech Companies in India for CDSCO Registration for Medical Devices
• Compliance Assurance Support for Stress-free Acquisition of CDSCO Medical Device Manufacturing License
• End-to-end Assistance in CDSCO Medical Device Registration
• Meeting the Requirements of Clients in the Medical Device Industry PAN India