Navigating the regulatory framework surrounding medical devices in India requires meticulous attention to detail, particularly when it comes to major changes such as alterations in the constitution of Indian Authorized Agents (IAA) or manufacturers. Understanding the implications and procedures involved in addressing these changes is essential for maintaining compliance and ensuring uninterrupted operations in the healthcare industry.
Impact of Changes in Constitution of the Indian Authorized Agents (IAA) or Manufacturer
Change in the constitution of the Indian Authorized Agents (IAA) or manufacturer is considered a major change in the regulatory landscape of medical devices in India. Unlike other post-approval changes, addressing the change in constitution follows a distinct regulatory pathway. Let’s delve into what constitutes a change in constitution and the process to be followed in such cases.
Understanding Change in Constitution
A company’s constitution is a legally binding agreement between a company and its internal members defining rules related to corporate governance, business activities, and the rights and obligations of its internal members.
According to the Medical Device Rules, 2017, a change in constitution of a licencee refers to alterations in the structure of the licensee, in relation to –
- a firm means change from proprietorship to partnership including Limited Liability Partnership or vice versa;
- a company means-
- its conversion from a private to a public company, or from a public to a private company; or
- any change in the ownership of shares of more than fifty per cent. of the voting capital in the body corporate or in case of a body corporate not having a share capital, any change in its membership; and where the managing agent, being a body corporate is a subsidiary of another body corporate, includes a change in the constitution of that other body corporate
Typically, the Memorandum of Association (MOA) is necessary for comprehending the company’s structure. Therefore, we can deduce that alterations in the MOA constitute changes in the company’s constitution and is regarded as major changes.
Constitution details are compulsory for many applications submitted to CDSCO, particularly for Manufacturing and Import License applications. The MOA must be provided with these applications to illustrate the company’s constitution (either of a domestic manufacturer or an authorized agent).
Impact for Domestic or Indian Manufacturers
For domestic manufacturers, any changes to the company’s constitution post-grant of the manufacturing license require notification to the Licensing Authority within 45 days of implementation. Subsequently, a fresh application for a new license must be submitted within 180 days from the date of the change in constitution. The existing license remains valid until the issuance of the fresh license.
Impact for Foreign Manufacturers or Indian Agents
Similarly, for foreign manufacturers or Indian agents, changes in the constitution post-grant of the import license necessitate written notification to the Central Licensing Authority within 30 days of the change. A fresh application for a license must be made within 180 days from the date of the change in constitution, with the existing license remaining valid until the issuance of the fresh license.
| Manufacturing License | Import License | |
| Governing Authority | State/Central Licensing Authority | Central Licensing Authority |
| Notification Timeline | 45 days | 30 days |
| Requirement for Fresh Application | Yes | Yes |
| Timeline for Submission of Application | 180 days | 180 days |
| Validity of Existing License | Valid until the issue of fresh license | Valid until the issue of fresh license |
In summary, changes in constitution are critical events that require prompt notification and adherence to regulatory procedures to ensure continued compliance in the dynamic landscape of medical device regulations in India. Manufacturers and agents must remain vigilant and proactive in addressing such changes to mitigate any potential disruptions to their operations.
Stay informed and compliant with the latest regulations governing medical devices in India. For expert guidance and assistance in navigating the regulatory landscape, reach out to 8C Healthcare today at contact@8chealthcare.com and let us help you ensure seamless compliance and continued success in the medical device industry.
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