Product Registration: Our team can help you navigate the complex process of registering medical devices with the Central Drugs Standard Control Organization (CDSCO). We provide comprehensive support for document preparation, submission, and follow-up to ensure a smooth registration process.

Import/Export Compliance: If you are importing or exporting medical devices in India, compliance with regulations is essential. Our team can help you obtain the necessary licenses and approvals for your products, ensuring that they meet all relevant regulatory requirements.

Quality Management Systems: Quality management is critical for ensuring the safety and efficacy of medical devices. We can help you develop and implement a quality management system (QMS) that meets all regulatory requirements and ensures compliance with ISO 13485 standards.

Labeling and Packaging: Proper labeling and packaging are essential for ensuring the safety and effectiveness of medical devices. Our team can help you develop labeling and packaging solutions that comply with all regulatory requirements and industry standards.

Post-Market Surveillance: Once your medical device is on the market, it is important to monitor its performance and safety. We can help you develop a post-market surveillance plan that meets all regulatory requirements and ensures ongoing compliance.

At AkinoIndia, we are committed to providing our clients with the highest level of service and support. Our team of regulatory experts has extensive experience in the medical device industry, and we stay up-to-date with the latest regulatory changes to ensure our clients' products are always in compliance.

Contact us today to learn more about our medical device regulatory solutions and how we can help your business succeed in the Indian market.