If you are looking for authorized agent or representative for your medical device registration, you are on right platform. Medwisdom Lifescience is your trusted “Authorized Agent For Medical Device Registration” In India. With our knowledge and experience in medical device, we bridge the gap between manufacturer and CDSCO, ensuring your product meets regulatory standard and reaches to users and public effectively. Our commitment to you as an authorized agent, we not only provides regulatory services for your products but also assist you as a local partner, ensuring your brand gets 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 get the registration and legal work for their products. Some of the major responsibilities of authorized agent includes:
- Regulatory Compliance: Ensure your medical device meet 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
Authorized agent is essential for medical device registration in India, to ensure regulatory compliance of medical device as per the regulatory requirements under the Medical Device Rules, 2017. Here are some points discussed on what is the need of authorized agent:
- Regulatory Representative On Manufacturer Behalf: Foreign manufacturer without a physical presence in India, hires an agent or representative on their behalf to represent them for communicating with the Indian regulatory authority CDSCO.
- Compliance Expertise: An Authorized agent have the experience in securing medical device registration, because of continuous indulging in one specific field, he knows the pathway to navigate the complexity of regulatory compliance.
- Documents Submissions: Agent handles the submission of documents, dossier, and deceleration by manufacturer or importers, which are essential for securing registration of medical device.
- Location Market Understanding: With complete knowledge of Indian regulatory market, an agents facilitate challenges smoothly without much difficulty.
Medwisdom Lifescience Unique Proposition
We are well known about the regulatory requirements of CDSCO for securing the registration of medical device in India. Some of our unique qualities being authorized agent includes:
- Local Expertise With Global Outlook: We understand the complete process of obtaining registration certificate for medical device in India while maintaining global standard. Our experts team stays updated with global regulations and rules for medical device.
- Cost Effective Solutions On Time: Avoid delays and extra cost 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 marketing intelligence to make informed decisions, provide our clients better end results.
- QMS: We guide our clients through quality management system services for medical device in maintaining the quality and regulatory compliance of product throughout entire product lifecycle.
Why Choose Medwisdom Lifescience As Your Authorized Agent?
- Transparency in work
- Rich experience in collaboration with CDSCO
- Quick and timely response
- End to End regulatory compliance
- Our clients is our first priority
- Cost effective services with timely output
FAQS
Who Would Needs Authorized Agent Service In India?
Foreign manufacturer who is looking to sell and market medical device in India but don’t have any partner or any representative needs an authorized agent.
Can Foreign Manufacturer Directly Sell Medical Device In India Without Authorized Agent?
No, foreign manufacturer cannot directly sell or market medical device in India without any representative or authorized agent.
Qualification or Eligibility For Being An Authorized Agent For Medical Device In India?
He must be based in India, must be well versed with Medical Device Rules, 2017, and hold a valid wholesale drug license.