India Medical Devices Regulations



With the increasing demand of effective care and patient management system, regulations are becoming stringent worldwide and the countries are moving toward updating their regulatory framework while making them unified. On similar lines, Indian medical device industry has evolved rapidly and is moving towards growing ‘regulated’.

With the new Medical device regulations amendment in 2017 and 2020, India is moving towards harmonized regulations showing analogy to EU MDR.

India medical devices regulatory services



Classification and Registration of Medical Devices & IVDs:


Central Drug Standards Control Organization (CDSCO) classification for medical devices and IVDs has a set of risk classifications for several products intended to be notified in India with specific guidelines of market entry for these medical devices. 

As a responsible medical device regulatory partner, Athreva provides strategic consulting service for medical device manufacturers and right from complex strategic market entry to operational needs with the following services:

  • Product classification as per India guidelines
  • Diagnosing the existing technical file and report status by executing gap analysis

Athreva can handle all regulatory requirements pertaining to all types of medical devices, be it Class I, Class II, and Class III devices 


Registration
Since 2017, new medical device regulations in India emerged as a regulated market citing defined registration requirements and classification systems for medical devices and IVDs to be manufactured/ marketed/ imported in India. With a team of seasoned regulatory professionals, being well-versed with the requirements, Athreva can assist manufacturers in preparing and reviewing medical device registration documents. 


With the following steps, Athreva can reduce unnecessary market entry delays and help come up with an efficient launch strategy:     

Legal Representative

  • Strategizing device market entry with defining the regulatory requirement 
  • Analyzing the local nuances for foreign manufacturers and adopting a cost-efficient approach for entry of medical device in India 
  • Diagnosing the existing technical file and generating a gap analysis report 
  • Determining the local clinical requirements for the products
  • Support with managing regulatory documentation and making the package audit ready
  • Support in obtaining approval and registration certificate


Regulatory Strategy for Medical Devices in India 


The Central Drug Standards Control Organization (CDSCO) is India’s key regulatory association for medical devices. Drug Controller General of India (DCGI) is the key representative in the CDSCO. The DCGI is responsible for the approval of specific medical devices.   

Athreva can support you with:

  • Strategizing market entry in India with identifying the launch strategy 
  • Finding gaps in an existing technical file 
  • Strategizing QMS/ ISO 13485 needs


Device Labelling & Promotional Material

  • Support for labelling design
  • Gap analysis of existing label to meet local requirements
  • Advice on promotional material design

Legal representation/ Authorized Representation for Medical Devices in India


In India, there are three ways of choosing a local agent to represent your medical device: 

  • Have your local distributor act as your representative and apply for product registration in the name of the distributor
  • Invest in setting up a local establishment in India 
  • Have an individual legal entity or representative that will hold the product registration in your company’s name, for a fee 
Medical Devices Registration

Athreva team can assist you with the following services: 

  • Managing relations with distributors and assisting them for regulatory services
  • Support with strategizing a local establishment in-country
  • AAdvice on determining the administrative requirements - individual legal entity or representative that will hold the product registrations in company’s name 
  • Act as a legal representative in India 
  • Incident reporting and liaising with HA for event reporting and communication 

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