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CDSCO Medical Device Registration

CDSCO

Medical Device Registration

Indian CDSCO (Central Drugs Standard Control Organization) registration consultants for medical devices play a crucial role in assisting manufacturers, importers, and other stakeholders in navigating the complex regulatory landscape in India.

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CDSCO (Central Drugs Standard Control Organization) plays a pivotal role in regulating the approval and distribution of medical devices in India, and navigating its intricate regulatory landscape can be a complex and daunting task. With ZYPS Strategist, you can confidently navigate the regulatory intricacies and harness the immense potential of the Indian medical device market.

  • Classification of Medical Device
  • Submitting the Application
  • CDSCO Review
  • Approval or Rejection

CDSCO Medical Device Registration

MD online CDSCO registration is a platform provided by the Central Drugs Standard Control Organization (CDSCO) for the registration of pharmaceutical products, medical devices, and cosmetics. It enables manufacturers, importers, and distributors to apply for the necessary licenses and approvals required for the sale and distribution of their products in India. The online registration process is aimed at improving the efficiency and transparency of the regulatory system.

Quick navigation for CDSCO Medical Device Registration process

CDSCO Certification

The CDSCO certification process is integral to evaluating and approving medical devices and IVDs for use in India.
This rigorous process entails a comprehensive assessment of the device's design, manufacturing processes, and performance data. Upon obtaining CDSCO certification, a medical device becomes eligible for marketing and sale within India.
This certification plays a crucial role in ensuring that medical devices used in the country adhere to the utmost standards of safety and quality.

Based on the findings of the technical evaluation, QMS audit, and clinical evaluation (if applicable), CDSCO makes a decision on whether to grant certification.

If the device meets all requirements, CDSCO issues the certification allowing the device to be marketed and sold in India.

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CDSCO Manufacturing License Registration for Medical Devices


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It is compulsory for all medical devices manufactured in India to possess a CDSCO Medical Device Manufacturing License.

  • For Class A and B medical devices, the manufacturing licenses will be issued by the State Licensing Authority. The effectiveness of manufacturing licenses for Class A and B starts from 1st October 2022.

  • For Class C and D medical devices, manufacturing licenses will be issued by the Central Licensing Authority. The CDSCO manufacturing license will be applicable for all non-notified Class C and D devices starting from 1st October 2023.

Step-by-step Guide to the Process of CDSCO Medical Devices Registration

  • Step 1 : Classification of Medical Device as per CDSCO Regulatory Guideline

    The initial stage in the CDSCO registration process involves categorizing medical devices appropriately. Following classification, the subsequent step is compiling the application dossier. This dossier must encompass comprehensive details about the medical device or drug, comprising its composition, formulation, manufacturing procedures, mandatory regulatory certifications, and intended purposes. Additionally, the application should encompass all pertinent clinical trial data, if accessible.

  • Step 2 : Submitting the Application on the CDSCO Portal Online

    Upon preparation, the application must be submitted online via the CDSCO portal along with the requisite CDSCO fees. Subsequently, CDSCO will scrutinize the application and may seek supplementary information or clarification if deemed necessary.

  • Step 3 : CDSCO Review

    Upon receipt of the application, CDSCO will assess its content to ascertain the safety and efficacy of the drug or medical device for its designated purpose. This evaluation may encompass a thorough review of pertinent data, site inspections, and consultations with experts in the pertinent field.

  • Step 4 : Approval or Rejection

    Following the evaluation, CDSCO may grant approval for the sale and distribution of the drug or medical device in India. Conversely, if it determines that the product fails to meet the necessary safety and efficacy standards, the application may be declined.

Wholesale License for Medical Devices in India

To acquire a wholesale license for medical devices, one must initially register their business with CDSCO and furnish essential documentation, including premises verification, a device inventory, and confirmation of compliance with quality management standards. Subsequently, CDSCO conducts an inspection of the premises and documentation before granting the license. It's crucial to recognize that various medical devices may necessitate distinct licenses, and seeking guidance from regulatory experts or legal professionals is recommended to ensure adherence to all relevant laws and regulations.

CDSCO MD 41 serves as a crucial document employed by CDSCO in India for registering certain medical devices that have a recognized predicate device within the country. This predicate device, having previously secured approval for use in India, serves as a benchmark against which the safety and efficacy of new devices are assessed.

Conversely, MD 42 is another vital form utilized by CDSCO, specifically tailored for registering medical devices lacking a predicate device within India. This form mandates comprehensive details concerning the device, its intended purpose, and information about the manufacturer.

For more precise insights into MD 42 or CDSCO's registration procedures concerning medical devices, seeking guidance from ZYPS Strategist, a reputable regulatory consultancy in India, is advisable. They possess the requisite expertise to offer tailored assistance in navigating the regulatory framework effectively.

Classification of Medical Devices as per Indian CDSCO Regulations

The Central Drugs Standard Control Organization (CDSCO) in India categorizes medical devices into four groups, depending on the degree of risk they present to patients and users. This classification system is determined by the device's intended use and the potential harm it may cause in case of malfunction. For further clarity on the classification of medical devices, please refer to the provided document titled "Clarity on Medical Device Classification."


Below are the four classifications of medical devices according to CDSCO:

  • Class A: Low-risk medical devices, like stethoscopes, bandages, and other essential medical instruments, pose minimal to no risk of harm to patients or users.

  • Class B: The licensee must allow the Medical Device Officer to access the premises, whether with prior notice or not, to verify that only authorized activities, such as clinical investigations, tests, evaluations, examinations, demonstrations, or training, are being carried out.

  • Class C: Medical devices categorized as moderate-to-high risk include artificial heart valves, orthopedic implants, and catheters, which have the potential to cause significant harm or injury to patients if they malfunction.

  • Class D: High-risk medical devices, such as pacemakers, heart-lung machines, and ventilators, are crucial for the health and survival of patients. If these devices malfunction, they could result in severe harm or even death.

Who Can Apply for CDSCO Registration In India?

  • # Manufacturers of Medical Devices and IVDs within the country

  • # Importers of Medical Devices/IVDs/Cosmetics

  • # Overseas Manufacturers of Medical Devices and IVDs

  • # Authorized Representatives of Medical Devices and IVDs

  • # Indian Branch of Medical Devices and IVDs

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What are the prerequisites for registering medical devices in India?

  • --> Adherence to Indian laws and regulations

  • --> Details of manufacturing facilities

  • --> Regulatory certificates such as European CE, Free Sale Certificate, ISO 13485, etc.

  • --> Requirements for labeling and packaging

  • --> Registration fees for CDSCO

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What are the Benefits of CDSCO Registration?

Obtaining CDSCO registration stands as a vital milestone for any medical device manufacturer or importer aiming to penetrate the Indian market. It offers numerous advantages, including:

  • Market access: Obtaining CDSCO registration enables manufacturers to distribute and sell their products in the expansive Indian market, renowned as one of the largest pharmaceutical and medical device markets globally.

  • Brand recognition: CDSCO registration elevates the manufacturer's brand visibility and reputation by showcasing adherence to stringent safety, efficacy, and quality standards for their products.

  • Regulatory compliance: CDSCO registration signifies the manufacturer's adherence to Indian regulatory mandates, encompassing Good Manufacturing Practices (GMP) and Medical Device Rules (MDR).

  • Competitive advantage: CDSCO registration grants a competitive edge by serving as a prerequisite for participation in government and private tenders and procurement processes.

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How ZYPS Strategist will Help you to Get a CDSCO License for Medical Devices Registration in India?
ZYPS Strategist is a medical device regulatory consultant and assists in CDSCO registration, We make sure that clients from various countries get hassle-free results within the timeframe.

You can reach us anytime via info@zyps.co.in

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