Legal Implications of the CDSCO License Update for Class C and Class D Medical Devices

In a recent notice by the CDSCO, new licensing requirements have been introduced for Class C and Class D medical devices for all importers/manufacturers across India effective from the 1^st of October 2023. This regulatory update will not only aid in the smooth progress of the supply of medical devices but also ease the challenges faced by importers/manufacturers in licensing procedures.

India has one of the largest medical devices industries in the world. In order to regulate this booming industry, the Medical Device Rule 2017 (MDR 2017) was established on 1^st January 2018 for the purpose of regulatory requirements for medical device companies. These regulations are overseen by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare in India. The CDSCO acts as the National Regulatory Authority of India (NRA).

With effect from the 1^st of October 2023, the CDSCO has announced that it will implement complete licensing requirements for Class C and Class D Non- notified medical devices. The CDSCO has notified all importers/manufacturers to apply for the licenses (along with the required documents) before the October deadline so as to avoid any disruption in the flow of medical devices in India.

This regulatory update is extremely important as this marks the final step in transitioning all medical devices to the new rules. The CDSCO is currently alerting all importers/manufacturers to the said deadline to avoid them getting affected, as there were no licensing requirements previously. Failure to do so may lead to heavy penalties in the medical devices market.

Understanding the New Update:

According to the new update issued by the CDSCO –

• All Class C and Class D medical devices (non-notified) must be submitted under the mandatory license process
• This registration number process is only available till the 1^st of October 2023.

Legal Implication of CDSCO Directive:

Importers/manufacturers failing to register for their respective licensesand non-compliance with the said legislation will lead to strict penal action against them, as established under the Drugs and Cosmetics Act, 1940.

The licensing of medical devices across India has a huge impact on the industry and market dynamics as well,

• The medical devices industry in India has a diverse system of stakeholders such as medical devices, academics, and the government. Hence, there is a lot of potential for research, development, and innovation.
• The government must work towards private sectors, universities, and investors for the long-term growth of the medical devices industry.
• The above can be achieved by regulatory and policy reforms, research, fundings and licensing etc. These in turn will create better job opportunities across the country.

Challenges faced by Medical Equipment Indian Importer/ Foreign Manufacturers:

• The CDSCO licensing process for medical devices is challenging and time-consuming involving paperwork with stringent regulatory requirements. Here are the different challenges faced by the importers/manufacturers in India with the onset of these new regulations:Manufacturers have to apply for a grant of manufacturing or import license with all the documents listed. This provesto be an arduous task since previously these classes wereexempted from the rigorous regulatory compliances.
• The import of license process alone can take up to 6 months.
• Reimbursement challenges are present for manufacturers too.
• Small to medium manufacturers will need a trusted partner to avoid any legal implications as they might not have large/experienced legal and finance teams with experts to deal with such situations.
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Forms for the manufacturing licence of Class C and D Medical Devices in India

The Central Licensing Authority of India or CDSCO grants the medical device manufacturing license. The following table provides an insight into the different forms for the licensing procedure

The Process and Required Documentation:

From the 1^st of October 2023, Class C and Class D non-notified medical devices will be required to undergo the licensing process for medical devices.

• All Class C and Class D non-notified medical devices must now be submitted online on the CDSCO website
• The applicant must submit MD-7 (manufacturing license) or MD-8 (loan license) depending on the type of license they seek.
• The Indian Authorized Agent (IAA) or applicant must then submit the technical file along with the required documents to the Regulatory Authority.
• Medical Device Officers (MDOs)are required to complete inspection within 60 days of application of manufacturing license.
• CDSCO will take a decision once the MDOs grant approval.
• Once the documents are verified and approved, CDSCO will grant a manufacturing license under Form MD-9 or grant a loan license under Form MD-10.

The major documentation required for the licensing process is:

• ISO 13485 certificate
• Product information
• Declaration of Conformity (DOC)
• Certificate of Analysis (COA)
• Design Master File (DMF) and Plant Master File (PMF).

The Role of Authorized Agents:

Since international manufacturers would not have any knowledge of medical devices registration in India, they can appoint an “authorized agent”. An authorized agent is an establishment in India who will be responsible for all business activities of the international manufacturer and act as a point in India so as to ensure compliance to all the rules laid out in the Drugs and Cosmetics Act, 1940.

There are many benefits for international manufacturers by the Indian authorized agent. A few of them are:

• They help international companies in seeking potential distributors for launching their products in India.
• They help with imports and customs clearances.
• They provide warehouse support for distribution of products.
• They also provide legal and post-marketing surveillance support. 
• No matter how many distributors are changed during the entire process, you only need to register once with the help of a good authorized agent.
• Legal compliances like pre-certifications, post marketing surveillances queries and other queries can all be handled by a competent authorized agent.
• They are fully updated on the latest regulatory requirements and prevent chances of application rejection.
• They are aware of the application guidelines and documents necessary to back the application.

Conclusion:

In conclusion, India being one of the leading medical devices markets in the world, it is of prime importance that stringent regulations are laid to ensure patient safety. The CDSCO has hence, laid out these legislations and updates in order to oversee the smooth and integral use of medical devices to meet the healthcare needs of patients across the country.

The CDSCO licensing procedure is a complex and time-consuming process but holds multiple benefits for the manufacturer such as brand recognition, launch of high-quality products that are compliant with industry norms, regulatory compliances, and also helps to broaden market access. Hence, an authorized agent such as CliniExperts can help smoothen the registration process, and make it hassle-free and fast..

Reference:

https://cliniexperts.com/regulatory-update/class-c-class-d-medical-devices-regulatory-update-2023/