ICMED 13485 & ICMED 9000 Scheme

To fill the regulatory vacuum in quality certification space for medical devices in the country, the Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) is rolling out a voluntary quality certification scheme for medical devices.

The Scheme is intended to enhance patient safety, and provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers. This move is also intended to significantly eliminate trading of sub-standard products or devices of doubtful origins, a widespread and injurious phenomenon in the Indian market.

Association of Indian Medical Device Industry (AIMED) jointly with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB) rolled out a voluntary quality certification scheme for Medical Devices for level I and level II viz. ICMED 9000 and ICMED 13485 on March 15th, 2016 World Consumer Day. While on one hand ICMED 9000 Certification scheme lays out the parameters of ISO 9001, on the other ICMED 13485 align itself with the ISO 13485 along with Indian MDR 2017 requirements.

ICMED 9000 Certification which is as per the requirements of ISO 9001 read with the additional requirements prescribed under the Scheme in ICMED 9000.

 ICMED 13485 which is as per the requirements of ISO 13485 read with the additional requirements prescribed under the Scheme in ICMED 13485

• Enhanced Risk Management
• Improved Customer Satisfaction
• Better Access To Information
• Improved Business Reputation
• Ability To Win More Business.
• International Expansion Opportunities

The certification process is a multiple-step process. The certification cycle is described briefly:

• Application for certification from client
• Offer from TUV India
• Offer acceptance from client and order confirmation by TUV India
• Pre audit (optional)
• Certification audit - (Stage 1 + Stage 2)
• Issue of certificate on successful completion of certification audit
• Surveillance audits 1 – After 12 Month , Surveillance audits 2 Audit – unannounced – 9 to 12 month after SA1
• Recertification audit after 3 year

The Certification Scheme is built over the base Standard ISO 13485 (Quality Management System for Regulatory Purposes) which had 184 Compliance Requirements. The ICMED 13485 has in addition 23 regulatory requirements, 13 essential requirements for ensuring patient safety and with 16 labelling requirements for ensuring consumer protection. The Certification is available through NABCB accredited certification bodies of international repute for this Scheme. It is pertinent to mention that VCS for ICMED 9000 and ICMED 13485 are equipped in its capacities to cater to the medical devices’ requirements for domestic acceptance. However, the domestic manufacturers still require to adhere to the norms & regulations of FDA/CE certification to broaden their scope for global acceptance.

Our team will work with your organisation to facilitate the process of achieving the certification. TUV India's audits certify your organisation as being committed to continual improvement and customer satisfaction. Our team of competent auditors ensures your organization’s fulfilment of customer as well as statutory & regulatory requirements.