. . .

Indian Certification for Medical Devices (ICMED 9000 / ICMED 13485)

Regulation of medical devices and their quality systems in India was limited compared with other developed nations that typically have very robust approval systems for medical devices in place.


Satisfied Customers


Global Business Setups


Professionals (CA,CS, Lawyers)



[ Rated 4.9 Stars By 7863+ Customers Globally]
Slider One


Regulation of medical devices and their quality systems in India was limited compared with other developed nations that typically have very robust approval systems for medical devices in place.

Together with the Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB), the Association of Indian Medical Device Industry (AIMED) has developed a voluntary quality certification scheme for medical devices in India, Indian Certification for Medical Devices (ICMED)

It is the country's first indigenously developed quality assurance system mandatory for all medical devices marketed in the nation. This was proposed in a recent meeting called for the drafting of (separate) rules for medical devices with government officials with a special focus on drafting regulatory framework for the granting of medical device manufacturing licenses.

The meeting discussed how to proceed with the registration of manufacturers and importers of medical devices on an online GoI portal. Most importantly, the meeting stressed the need for the registration of low-risk and moderate-risk devices based on certification by 3rd Party (CAB) and the granting of a manufacturing license to manufacturers and importers of high-risk devices based on specified criteria. This will be achieved by CDSCO medical devices officers with a predefined competency or by certification bodies of 3rd party according to sources.

Objective of certification;

➲  It is aimed at enhancing patient safety and provides enhanced customer protection.

➲  The scheme is intended to significantly eliminate the trading of sub-standard products or devices.

➲  Most significantly, it will reduce considerable time and costs for Indian companies to receive internationally recognized quality certification,

Benefits of certification

Benefits of registration

➲  Build brand trust of medical devices manufactured in India

➲  Enhance patient safety

➲  Provide healthcare users with quality medical devices manufactured in a certified facility

Who can apply for certification?

➲  Indian manufacturer or exporter

➲  Indian medical device importer/distributor

ICMED certification is of two type:

ICMED certification is of two types:

➲  ICMED 9000 (an ISO 9001plus additional requirement)

     This certification is for low-risk medical devices

➲  ICMED 13485 (an ISO 13485 plus additional requirement)

     This certification is for medium or high-risk devices.

Procedure and Documentation

Procedure for certification:

➲  File application form along with required document and fees

➲  The certifying body will raise a query if any within 7 working days from the receipt of application

➲  The applicant will respond to that raised query in the prescribed format

➲  Audit program

For ICMED 9000 & ICMED 13485 the audit cycle shall include:

  • Initial certification audit in two stages (Stage 1 and Stage 2) as per ISO 17021:2011 for ICMED 9000 and ICMED 13485
  • Recertification audits (before end of 3-year validity)

➲  Granting of certification

Documents required for citification:

➲  Organization registration certificate

➲  Organization detail (Manufacturing/importer)

➲  Organization authorized signatory detail (ID and Address proof)

➲  Medical equipment detail

➲  Holding ISO certificate

➲  Importing company detail  and exporting company detail (in case of import)

  • STAGE 1


    We are just a call or message away!

    Call or WhatsApp us on +91-99991-39391 for free consultation from our team of experts. You can also email us on [email protected].

  • STAGE 2


    Your consent is essential!

    We share the detailed and reasonable estimated costs, documents and prerequisites for the complete process before starting the process to ensure transparency.

  • STAGE 3


    We ensure timelines are met!

    Our team warrants hassle free documentation. We collect the necessary documents and share the relevant drafts to ensure a timely filing and delivery.

  • STAGE 4


    Precision is our speciality!

    Upon collecting the necessary documents and information, we waste no time in preparation and filing of your application. development on your application is brought to your attention.

  • STAGE 5


    We deliver what we commit!

    On successful completion of the case we share all the relevant documents electronically and physically along with an assurance to pay you back if something is wrong.

Request A Callback
Related Services

Expert Legal Advisory Our Customers Love

Bespoke advisory focused on mission critical legal, financial and business aspects.

server room

Trusted By Clients And Industry Experts

At Corpzo, our clients’ success stories speak volumes. Discover how businesses across various industries have leveraged our expertise to achieve their goals. Read firsthand accounts of our commitment to excellence and the impact we've made in supporting their growth and compliance needs.

Empowering You with Expert Insights and Knowledge

At Corpzo, we are dedicated to empowering our clients with valuable knowledge and insights. Our team of experts regularly shares in-depth articles, comprehensive guides, and industry updates on Knowledge Varsity. Whether you're looking for the latest trends in alternative investment funds or need expert advice on navigating the complexities of drug licensing, our resources are designed to keep you informed and ahead of the curve. We believe that informed clients make better decisions, and our goal is to provide you with the expertise you need to succeed.

Explore CorpZo Insights
Let’s chat? - We're online
Corpzo Chat Now Corpzo Chat Image
Book An Appointent


From Mumbai Recently Purchased @Partnership Firm Registration