Authorized Agent For Medical Device Registration In India
If you are looking for an authorized agent or representative for your medical device registration, you are on the right platform. Medwisdom Lifesciences is your trusted “Authorized Agent For Medical Device Registration” In India. With our knowledge and experience in medical devices, we bridge the gap between manufacturer and CDSCO, ensuring your product meets regulatory standards and reaches users and the public effectively. Our commitment as your authorized agent not only provides regulatory services for your products but also assists you as a local partner, ensuring your brand achieves long-term success in both domestic and international markets.
What Does It Mean Being An Authorized Agent For Medical Device Registration?
It means an agent recognized by the Indian regulatory authority to act on behalf of manufacturers, to handle registration and legal work for their products. Some of the major responsibilities of an authorized agent include:
- Regulatory Compliance: Ensure your medical device meets required regulatory framework and technical standards to grant product approvals.
- Market Entry: Simple and seamless market access of your products in India’s growing healthcare sector.
- End to End Support: Act as representative of manufacturer or importer, with complete support and guidance throughout product lifecycle and approval.
Need Of Authorized Agent In Medical Device Registration In India
An authorized agent is essential for medical device registration in India to ensure regulatory compliance as per the Medical Device Rules, 2017. Here are some key points on the need for an authorized agent:
- Regulatory Representative On Manufacturer's Behalf: Foreign manufacturers without a physical presence in India hire an agent or representative to communicate with the Indian regulatory authority CDSCO.
- Compliance Expertise: An authorized agent has experience in securing medical device registration and knows how to navigate the complexity of regulatory compliance.
- Documents Submissions: Agent handles the submission of documents, dossier, and declarations by manufacturer or importers, which are essential for securing registration of medical devices.
- Local Market Understanding: With complete knowledge of the Indian regulatory market, agents facilitate challenges smoothly without much difficulty.
Medwisdom Lifesciences Unique Proposition
We are well-versed in the regulatory requirements of CDSCO for securing the registration of medical devices in India. Some of our unique qualities as an authorized agent include:
- Local Expertise With Global Outlook: We understand the complete process of obtaining registration certificate for medical devices in India while maintaining global standards. Our expert team stays updated with global regulations and rules for medical devices.
- Cost Effective Solutions On Time: Avoid delays and extra costs of services, to reduce additional charges and provide optimum expenses with timely approval.
- Product Lifecycle Management: From pre-market approval to post-marketing surveillance (Pharmacovigilance), we provide comprehensive regulatory solutions and complete product lifecycle support.
- Strategic Decision Provider: Leverage our market intelligence to make informed decisions, providing our clients better end results.
- QMS: We guide our clients through quality management system services for medical devices in maintaining the quality and regulatory compliance of products throughout the entire product lifecycle.
Why Choose Medwisdom Lifesciences As Your Authorized Agent?
- Transparency in work
- Rich experience in collaboration with CDSCO
- Quick and timely response
- End to End regulatory compliance
- Our clients are our first priority
- Cost effective services with timely output
FAQs
Foreign manufacturers who are looking to sell and market medical devices in India but don’t have any partner or representative need an authorized agent.
No, foreign manufacturers cannot directly sell or market medical devices in India without any representative or authorized agent.
The agent must be based in India, must be well-versed with Medical Device Rules, 2017, and hold a valid wholesale drug license (or equivalent registration certificate for medical devices, such as MD-42). Additional requirements typically include being a registered entity with Corporate Identification Number (CIN), having a Power of Attorney from the foreign manufacturer, and registration on the CDSCO SUGAM portal.
