In this blog, we have focused on the differences between notified and non-notified medical devices in India. Additionally, we have provided an overview of the different regulatory processes for different categories of medical devices. Furthermore, we have touched upon the specific regulations for newly notified medical devices.

Differences between notified and non-notified medical devices

Notified devices

The CDSCO has released a list of medical devices that are considered notified devices. These medical devices need prior approval from the CDSCO before being sold in India. The notified medical devices are classified into four CDSCO classes. The CDSCO medical device classification is based on risk-level associated with each device and its intended use. The four CDSCO medical device classes are A, B, C, and D that have an increasing order of risk level. The CDSCO medical device classification has been formulated to simplify the license application process for notified medical devices in India. Notably, each CDSCO medical device class has a different regulatory process. Additionally, different sets of supporting documents and application form are required while applying for their registration with the CDSCO.

Non-notified devices

All devices that are not a part of the notified medical devices list released by CDSCO are considered “non-notified” devices. However, these medical devices are usually mentioned on the CDSCO portal. As per the Medical Device (Amendment) Rules, 2020, all non-notified medical devices may be voluntarily registered with the Central Licensing Authority (CLA). Furthermore, the CDSCO has laid down provisions for non-notified medical devices and a registration number has to be secured for non-notified medical devices. Any medical device manufacturer or importer can apply for registration of non-notified medical devices. However, foreign medical device companies will have to take the help of an Indian authorised agent to register their devices.

Notably, similar to notified medical devices, the non-notified medical devices should be safe, of high-quality, and effective. Although these medical devices have not been mentioned in the CDSCO list of notified medical devices, they cannot be compromised on quality, safety, and efficacy.

Examples of notified and non-notified medical devices

• Notified medical devices: Cardiac stents, X-ray machines, blood glucose monitoring devices, nebulizers, etc.
• Non-notified devices: Blood grouping sera, coveralls, adhesive drapes, ligatures, umbilical tapes, etc.

For the full list of examples of the two categories of medical devices, feel free to contact us. Additionally, our team will help you identify whether your medical device belongs to notified or non-notified medical category. Furthermore, we will help you identify which CDSCO class your medical device belongs to and the applicable regulations.

CDSCO regulations for notified and non-notified medical devices

The Central Drugs Standard Control Organization (CDSCO) is the apex regulatory body for both notified and non-notified medical devices in India. CDSCO strictly regulates all medical devices being marketed in India under the provisions of Medical Devices Rules. It functions under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. CDSCO regulates the approval, manufacturing, and marketing of all medical devices. It is responsible for ensuring the safety, efficacy, and quality of these products in India. By implementing best regulatory practices and exploiting scientific excellence, this regulatory body aims to ensure potent and quality medical devices are available in the Indian market. Thus, CDSCO plays a crucial role in protecting public health.  

All medical devices irrespective of whether they are imported or manufactured in India have to comply with the CDSCO regulations. Imported and locally manufactured medical devices may have slightly different regulations but both have to adhere to quality, safety, and efficacy benchmark. Additionally, foreign medical device companies will have to appoint an Indian authorised agent to function on their behalf in India. The Indian authorised agent will be responsible for everything related to the medical device in India, from securing import license, regulatory compliance to, if required product recalls.

Applications for registering both notified and non-notified medical devices must be submitted to the official CDSCO online portal, SUGAM. Furthermore, CDSCO manages all applications via the SUGAM portal.

Guide for registering notified and non-notified medical devices in India

• Identification of category: The first step for registering any medical device in India is to identify which category (notified or non-notified) the device belongs to. Notably, you have to check whether your device has been mentioned in the “notified medical devices” list. This is because notified and non-notified medical devices have different registration pathways and applicable guidelines. Furthermore, this step will determine the next course of action for registering your medical devices in India.
• Preparation of documents: Various supporting documents need to be prepared for CDSCO medical devices registration. Slightly different documents are required for notified and non-notified medical devices. Furthermore, CDSCO requires the documents to be written in English. Additionally, the documents should be arranged per the order specified by CDSCO.
• Applying on the CDSCO portal: The application along with the necessary supporting document need to be prepared. The application has to be submitted online to the CDSCO portal. Then, the CDSCO will review the registration application. If necessary, CDSCO may request additional clarification or information. All CDSCO queries need to be responded to.
• CDSCO inspection and review: This step is mainly applicable for notified medical devices. If required, the regulatory officials will inspect the medical device manufacturing facility to ensure the facility meets the quality and safety standards. Additionally, the regulatory body will evaluate whether the medical device is safe and effective. During the review process, CDSCO will analyse all relevant data, conduct site inspections, and consult experts in the relevant field.
• CDSCO approval or rejection: The CDSCO may approve the medical device for sale and distribution in India, if the product meets the required safety and efficacy benchmark.

Registering medical devices in India

Hence, registering a medical device with the CDSCO is a cumbersome and lengthy process. From correctly identifying the medical device category to preparing various documents, medical device licensing and registration is a mammoth task. Additionally, expertise in the CDSCO regulations is required to understand what are the applicable regulations for your devices. Moreover, different documents have to be prepared for different categories of devices. The support of a regulatory expert can make the process much easier.

This is where Pharmadocx Consultants comes into the picture. We can make the medical devices registration process a cake walk for you. We have over 27 years of experience in licensing and document preparation for registering medical devices in India. Our expertise can help you easily launch and grow your medical devices business in India. Feel free to reach out to us for medical device registration and licensing support.

Specifications for newly notified devices

On February, 2020, the Medical Device (Amendment) Rules, 2020 was introduced. A new chapter has been dedicated to the registration of newly notified medical devices by their manufacturers/importers. The manufacturers/importers of newly notified medical devices will be required to mandatorily register their medical device. If the manufacturers/importers fail to obtain the registration, then they will not be able to sell their devices in India. Furthermore, along with registration, importers/manufacturers will have to secure a license under MDR prior to the prescribed deadline.

Pharmadocx Consultants: Your trusted support for registering medical devices in India

Different regulations and registration processes are applicable for notified and non-notified medical devices in India. Thus, medical device companies will have to first check whether their device has been mentioned in the CDSCO list of notified medical devices. Then, they have to decide on the next course of action. Thus, the medical device licensing and registration process can be tricky and complicated. Hence, the guidance and support of an experienced consultant can make the registration of medical devices a seamless process. Pharmadocx Consultants can help you navigate through the complex registration process for medical devices in India. Call/Whatsapp us at 9996859227 or drop an email at [email protected] to get support and tips for medical devices registration/licensing.