India Regulatory Services

Introduction

With the implementation of new Medical Device Rules 2017 (“MDR 2017”), Indian medical device regulations have become more streamlined with the global regulatory requirement. In tune with the global practice, the 2017 Rules have introduced a risked based classification system and classified medical devices in to 4 classes A, B, C and D.

CLASS A

LOW

CLASS B

LOW-MODERATE

CLASS C

MODERATE-HIGH

CLASS D

HIGH

India has opted a mixture of US and EU Medical Device Regulatory system. Indian Regulatory Authority, CDSCO has designated some Notified Bodies like EU system. These Notified Bodies audit the quality system of the low risk device manufacture. However, for high risk devices CDSCO have kept the full regulatory control with themselves like US.

We at RBridge can help you with complete regulatory support for your India operations. Our services are –

We help customers to obtain the manufacturing license by preparing the dossier as per CDSCO requirements, submitting the dossier to SUGAM portal and responding to the queries raised by Authorities.

India has notified some medical devices. Companies need import license to import these devices in India. We help the customers to search predicate device and compare the Indian predicate device with the device under registration. We prepare the dossier, submit to CDSCO portal, respond to the CDSCO queries to obtain the license.

India classifies any device which is first time is in India as “NEW DEVICE”. New devices require Clinical investigation permission. Also, claims for new intended use or new population or new material or major design change may also need clinical investigation.

If a medical device is not a “New Device” for India but does not have a Free Sale Certificate by any of the GHTF countries (U.S, Canada, EU, Japan and Australia) needs to undergo clinical investigation.

We help our customers to get the test license to import the investigational device, chose them right CRO. We compile the data as per format suggested by MDR 2017 and submit to online portal to obtain the permission to perform the clinical investigation.

Indian manufacturers need to implement the Quality Management System (QMS) as specified in the Fifth Schedule of Medical Device Rules 2017. Indian QMS requirements are quite similar to Internationally recognized ISO 13485 requirements. we understand the unique needs and manufacturing scenarios of the industry. Our team will help you to create the documentation and provide adequate training. This includes the creation of the SOPs, work instructions, Quality Manuals, VMP’s, Process Validation documentation etc. In the next phase, we provide assistance to implement the system at shop floor and provide the need-based training to make sure that the system is adequately implemented.

Wholesale distribution license is mandatory for sale or distribution. Also, companies holding wholesale distribution license can be the Indian agent to get the import license. We help customers to comply with the requirements and obtain the license.

Small quantity of Class A or Class B or Class C or Class D of medical devices may be manufactured or imported for the purpose of clinical investigations, test, evaluation, examination, demonstration or training. We help the customer to file correct application and get the license.

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