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We are a leading consultancy organization specializing in Medical Devices, WHO GMP Compliance, providing end-to-end solutions for Regulatory Affairs, Quality Management Systems, Licensing, and International Certifications, as a Medical Device Regulatory Consultant and ISO Certification Consultant in India. With a proven track record of excellence, we have successfully guided more than 350 organizations across India and abroad in achieving compliance with national and international standards. Our consultancy covers a full spectrum of services — from manufacturing and import licensing to technical documentation and certification support.
The organization holds certifications for ISO 9001:2015 (QMS) ISO 13485:2016 (Medical Devices) ISO 22000 (FSMS) ISO 14001:2015 (EMS) ISO 45001:2018 (OHSMS) ISO 50001 (Energy) ISO/TS 16949 (Automotive) and SA 8000 (Social Accountability) standards.
Complete regulatory support for medical device licensing including preparation and submission of Form MD-5, MD-9, MD-10, and MD-11 as per CDSCO requirements. Our services also include Test License, Import License, Loan License, and Free Sale Certificates with end-to-end documentation, authority coordination, and timely approval support.
Comprehensive assistance for WHO-GMP certification including gap analysis, documentation preparation, and coordination with regulatory authorities for successful certification. We also provide expert support for COPP documentation and complete product dossier preparation in CTD and eCTD formats to meet global regulatory submission requirements.
We offer complete end-to-end coordination with regulatory authorities including CDSCO, State FDA, BIS, NABL, NABH, and international Notified Bodies. Our team manages communication, documentation follow-ups, compliance alignment, and approval tracking to ensure smooth regulatory processes and timely clearances.
We provide expert preparation of Technical Files, Risk Management Reports, and Clinical Evaluation Reports as per EU MDR 2017/745 requirements. Our services also include PMS and PMCF documentation, ensuring continuous compliance, patient safety, and successful CE marking for medical devices.
We support internal audit readiness through structured planning, auditor guidance, and system evaluation to ensure compliance with applicable standards. Our services include effective CAPA implementation, management review facilitation, and post-certification maintenance for continual improvement and sustained certification status.
From manufacturing to healthcare, our clients have achieved global recognition, operational excellence, and customer trust through our certification and compliance solutions.
Brand names (which is /registered under the Trade Marks Act, 1999) for a medical device in Form MD-14 need to be present in the Free Sale Certificate (FSC) issued to the legal manufacturer for indicating it is freely sold in the countries viz. Australia, Canada, Japan, European Union Countries, United Kingdom or the United States of America. In case if the Brand name is not mentioned in the FSC, then the Brand name should be mentioned as ‘Not Applicable’ in the Form MD-14.
The information on the Regulatory pathway to be followed for the Medical Device from its development to commercialization under Medical Devices Rules, 2017 is available in CDSCO website. (https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf documents/medical-device/RegulatoryMDR-2017.pdf )
Yes. The licensee shall inform the Central Licensing Authority in writing within a period of 30 days in the event of any change in the constitution of the overseas manufacturer or the authorized agent and submit an application under MDR-2017 within a period of 180 days from the date of such change in constitution. ➢In such cases, the existing licence shall be deemed to be valid till such time, the fresh licence is issued or application is rejected by the Central Licensing Authority.
The manufacturer needs to obtain a No objection certificate (NOC) from the concerned Licensing Authority for carrying out such activity at the overseas premises, by submitting relevant documents viz. copy of manufacturing license, the name and quantity of the medical device to be sent for such activity, copy of the agreement with the overseas firm to carry out such activity, etc.
Yes. Each Bharatkosh fee receipts needs to be linked with the application if there are multiple challans so that total fee details shall be freezed with the application on the portal.
Import License, Manufacturing License or Registration certificate issued under MDR-2017 shall continue to be perpetually valid till suspension or cancellation, provided that the licencee/registration holder shall pay a Licence/ Registration retention fee in every five years under the provisions of MDR- 2017.
The subsequent applicant (new agent) has to submit the documents viz. Form MD-14, Power of Attorney, Free sale certificate, requisite fees, wholesale license/ Form MD-42/ manufacturing license, Label, IFU and copy of import licence issued to earlier authorized agent along with the undertaking from the manufacturer stating that there is no change in the Device master file, Plant master file, under MDR-2017.
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