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Assistance in ISO 13485 Certification in India


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    CliniExpert-usp test license

    CliniExperts provides an end-to-end regulatory solution for the domestic and international markets. The team is fully updated on the latest IVD regulatory and ISO certification requirements. Manufacturers or importers who wish to apply for the ISO 13485 Certificate can approach the experts. They will provide complete support through every step of the regulatory process.

    Assistance in ISO 13485 Certification in India – Overview

    The purpose of this service is to assist in ISO 13485 certification process. ISO 13485 certificate is important for manufacturers, designers, suppliers and distributors of medical devices, including IVDs.

    The regulatory body involved in the process is the Accredited Notified Body. The following procedure needs to be followed to avail the ISO 13485 certificate:

    • Applicant needs to establish Quality Management as per ISO 13485 standards. And thus, implement them in the organization.
    • Once implemented, the applicant can reach out to the Accredited Notified Body. They will conduct an audit of the organization and provide certification upon successful review.
    • The timeline for the process is 6 to 9 months.
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    Who Can Apply?

    Designers, manufacturers, suppliers and distributors of IVDs can apply for ISO 13485 certification.

    Assistance in ISO 13485 Certification in India

    How To Apply?

    The Applicant must follow the following process:

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      Applicant must define the scope of the ISO 13485 Certificate, which will mention the objectives and scope of the certificate.
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      Applicant must select the notified body
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      Applicant must establish a quality management system
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      Applicant must work according to the established quality management system
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      Prepare for the audit
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      Get audited by the Accredited Notified Body. The notified body will audit the company for two to ten days, depending on the size of the organization. The organization will obtain the certificate(s) if it passes the audit.
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    Validity

    The validity of the ISO certificate depends upon the notified body.

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    Fee Involved

    The Government charges specific fees for the ISO 13485 certification process, which depends on the size and scope of the certificate.

    Important Documents

    Important Documents

    The following list of documents is required for the application process:

     
    • Quality Manual
    • IVD details file
    • Procedure for design and development
    • Document control procedure
    • Training Procedure

    Timeline to get from Central Drugs Standard Control Organisation

    6 to 9

    MONTHS

    Essential Tips

    The following tips will be beneficial during the application process:

     
    • Applicant must establish Quality Management System before the certification audit.
    • Applicant should ensure every stakeholder is trained.
    • Preliminary internal audit must be performed before the external audit. The following problems can be faced during the process, and must be avoided by good mock audit and thorough training:
      • Lack of adequate resources
      • Lack of qualified resources
      • A compliant culture of laxity
    Expert Advise

    Experts at CliniExperts provide the following advice:

    The Management team should review the quality management system for any loopholes. And thus, address them before the actual audit.

    The team should work according to Standard Operating Procedures and WIs.

    Applicant must ensure external suppliers should be audited.

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    Frequently Asked Questions

    Does compliance to ISO 13485:2016 demonstrate GMP?

    No. ISO 13485:2016 does not demonstrate compliance with GMP. They are separate requirements.

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    Why is the ISO 13485 certificate necessary?

    The ISO 13485 certificate is essential to implement a Quality Management Systemto achieve a high level of control, focus on safety, and tough requirements and standards that can benefit the manufacture of IVDs or its components.

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    Is ISO 9001 certificate sufficient to establish QM System?

    No. The ISO 9001 certificate is not enough to establish a certified QM System an ISO 13485 certification is required to prove compliance with regulatory requirements of medical devices

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    What is the current version of ISO 13485?

    The latest revision of ISO 13485 for QMS in IVDs companies is available from March 2016.

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    Does ISO 13485:2016 only apply to medical devices?

    Yes. The ISO 13485 isestablished explicitly for companies working in the IVDs field.

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    Are there testing requirements for ISO 13485?

    There are no special requirement of testing , but standards must be met.

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