Indian Certification for Medical Devices(ICMED) 13485 Certifications
What is Indian Certification for Medical Devices (ICMED) 13485?
Indian Certification for Medical Devices (ICMED) 13485 is a quality management system certification specifically designed for medical device manufacturers in India. It combines the requirements of two important standards: ISO 13485 and the Indian Medical Device Regulations. Here’s a breakdown of ICMED 13485:
ISO 13485: This is an internationally recognized standard for quality management systems in the medical device industry. It sets out the criteria for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
Indian Medical Device Regulations (IMDR): These are specific regulations laid out by the Central Drugs Standard Control Organization (CDSCO) in India to govern the quality and safety of medical devices in the country.
ICMED 13485, therefore, takes these two frameworks into account and provides a certification that signifies a manufacturer’s commitment to producing safe and effective medical devices that meet both international and Indian regulatory standards. This certification is crucial for manufacturers looking to market their medical devices in India and abroad, as it demonstrates adherence to quality and safety standards.
To achieve ICMED 13485 certification, a medical device manufacturer typically needs to undergo a thorough evaluation of their quality management system, including processes for design, manufacturing, testing, distribution, and post-market surveillance. This evaluation is typically conducted by accredited certification bodies or auditors.
By obtaining ICMED 13485 certification, medical device manufacturers can enhance their credibility, expand their market reach, and ensure compliance with Indian regulations, making it a valuable asset for businesses in the medical device industry in India.
Benefits of ICMED Certification
The Indian Certification for Medical Devices (ICMED) Certification offers several benefits to medical device manufacturers and the healthcare industry in India. Some of the key advantages of obtaining ICMED certification include:
Who can get of ICMED Certification?
ICMED certification is primarily aimed at medical device manufacturers in India. Here is a list of entities that can seek ICMED certification:
Validity of ICMED Certification?
ICMED Certification is valid for 3 years.
Documents Required for ICMED Certification
The extent of Documented Information differs as per:
Role of Shamkris and Process of ICMED Certification
Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.
The implementation process is described below:
Implementing Product Management System
Year on Year
ICMED certification is a quality management system certification specifically designed for medical device manufacturers in India. It combines the requirements of ISO 13485 and the Indian Medical Device Regulations to ensure the quality and safety of medical devices.
Medical device manufacturers, contract manufacturers, importers, distributors, and other organizations involved in the medical device industry in India can apply for ICMED certification.
ICMED certification typically includes a comprehensive evaluation of an organization’s quality management system, covering areas such as design, manufacturing, testing, distribution, and post-market surveillance.
The validity of ICMED certification can vary based on the specific type of certification, but it often follows a three-year cycle. Surveillance audits and recertification are conducted to maintain and renew the certification.
Benefits include compliance with Indian regulations, international recognition, enhanced credibility, market expansion opportunities, improved product quality, reduced risk, competitive advantage, and a focus on patient safety.
To apply for ICMED certification, organizations typically need to contact a certification body or agency accredited to perform ICMED evaluations. They will guide you through the application and assessment process.