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:
Compliance with Indian Regulations
ICMED certification ensures that medical devices meet the specific quality and safety requirements outlined in the Indian Medical Device Regulations (IMDR), which are enforced by the Central Drugs Standard Control Organization (CDSCO). This certification demonstrates a commitment to adhering to Indian regulatory standards.
International Recognition
ICMED is designed to align with ISO 13485, an internationally recognized standard for quality management systems in the medical device industry. This alignment enhances the acceptance and recognition of Indian medical devices in global markets.
Enhanced Credibility
ICMED certification enhances the credibility of medical device manufacturers. It signifies a commitment to producing safe and effective medical devices, which can instill confidence in both healthcare professionals and patients.
Market Expansion
ICMED certification can open doors to new markets for Indian medical device manufacturers. Many countries require ISO 13485 certification or equivalent for regulatory approvals, making it easier to export products.
Improved Product Quality
The certification process involves a thorough evaluation of the quality management system, leading to improved manufacturing processes and product quality.
Reduced Risk
By complying with stringent quality and safety standards, manufacturers can reduce the risk of product recalls, legal issues, and other adverse events.
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:
Medical Device Manufacturers
This includes companies involved in the design, development, manufacturing, and distribution of medical devices, such as surgical instruments, diagnostic equipment, implants, and more.
Contract Manufacturers
Firms that manufacture medical devices on behalf of other companies can also seek ICMED certification to demonstrate their compliance with quality and safety standards.
Medical Device Exporter
Companies exporting medical devices into India for distribution and sale can pursue ICMED certification to ensure that the products they import meet Indian regulatory requirements.
Distributors and Resellers
Entities involved in the distribution and sale of medical devices within India can benefit from ICMED certification to establish trust and compliance with quality standards.
Validity of ICMED Certification?
ICMED Certification is valid for 3 years.
Documents Required for ICMED Certification
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Organization’s size
- Activities performed by the organization
- Processes undertaken by the Organization
- Products and services offered by the organization
- The complexity of processes undertaken
- Competence of persons involved
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:
Time Frame
Task
Process
Day 1
Scope defined
Self Certification/NoBo
Selection
Cost Estimates
- Finding directive and ICMED standard applicable to the product
- Selecting the appropriate certification scheme
- Based on the scope of the product and certification scheme
Week 1
Developing Documents
- Technical file, Plant Master file and Test Protocol Management System Manual, Management System
- Procedures, Policy, Objectives, Forms etc.
- Review of Standard Operating Procedures (SOP)
Week 4
Implementing Product Management System
- ICMED Awareness training to QC manager and Production Manager
- Implementing a well-documented manual throughout the life cycle of the product
Week 8
Internal Audit
MRM
CAPA
- Internal audits identifying nonconformities related to ICMED requirements
- Management Review Meetings
- Corrective and Preventive Action plan for nonconformities
Week 10
Self Certification/NoBo
Audit
N-C Closing
- Shamkris acts on your behalf and assists you in the third-party audit
- Closing of any nonconformities identified by the Self Certification/NoBo
Week 12
Self Certification/NoBo
- ICMED certificates issued for 3 years
- Surveillance Audits yearly
Year on Year
Yearly Compliance
- Support of Yearly documentation for audit
FAQ
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.