Get in Touch with Us

Phone No.

+91 9540208881

Email ID

avinash.sharma@avinashmedtechsolution.com

Address

179/7a Krishna street no no 2 maujpur delhi 110053

FREQUENTLY ASKED QUESTIONS

What services does Avinash MedTech Solution provide?

We offer end-to-end consultancy for CDSCO registration, ISO certifications (ISO 13485, ISO 9001, ISO 14971), CE marking, BIS certification, ZED certification, and technical documentation.

Who needs CDSCO registration?

Any manufacturer, importer, or distributor dealing with medical devices in India must obtain CDSCO registration as per Medical Device Rules, 2017.

How long does CDSCO approval take?

The timeline depends on the device classification and documentation quality. Generally, it may take a few weeks to a few months.

What is ISO 13485 certification?

ISO 13485 is a quality management system standard specifically for medical devices, ensuring product safety and regulatory compliance.

Do you provide complete documentation support?

Yes, we handle complete documentation including DMF, technical files, and regulatory submissions.

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