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India - Regulation

ICMSR (India REACH)

India released the fifth draft of the Chemical (Management and Safety) Rules (ICMSR) on August 24, 2020. The ICMSR will regulate Substances, Substances in Mixture, Substance in Articles and Intermediates that are manufactured, imported, or placed in the Indian Territory. ICMSR is also known as India REACH.  

Notification is required for all substances that are in quantity above 1 Tonne Per Annum (TPA). Additionally, only substances that are listed in "Priority Substances Required to be Registered" in Schedule II of the ICMSR need to be registered. 

 

The ICMSR (India REACH) is expected to be notified to WTO in 2022 and come into force after 60 days of notification. India REACH will require Indian manufacturers and importers to comply with the regulation which includes notification and substance registration. For foreign manufacturers, they may appoint an Authorized Representation (AR) on their behalf to comply with the ICMSR (India REACH).  

 

BIS Certification

The BIS in BIS Certification stands for Bureau of Indian Standards. The establishment of a national standards body in India is based on the Bureau of Indian Standards Act established in 2016.  

The aims of the BIS Act include harmonious development of the activities of standardization, conformity assessment and quality assurance of goods, articles, processes, systems, and services. The responsible authority is the Bureau of Indian Standards

BIS certification is required by every manufacturer (Indian or foreign) of those who are manufacturing products under Compulsory Certification. 

Product certification includes two schemes: 

  • Product Certification Schemes: Scheme 1 - Indian Standards Institution (ISI)
  • Scheme 2 - Compulsory registration scheme (CRS). 

The list of products that requires BIS certification is constantly being extended. See our summary on BIS Mandatory Product list: for Scheme II and Scheme II.  

For non-Indian manufacturers to comply with BIS certification, Authorized Indian Representative (AIR) can be appointed to assist the application process, including:  

  1. Documentation and application submission  
  2. Factory inspection by Indian auditor 
  3. Provision of test samples by the AIR and execution of the tests 
  4. Marking and labelling of products with the standard or ISI marks for BIS certification 

 

In India medical device are governed by CDSCO (Central Drugs Standard Control Organization) which is regulated by Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. Many committees have been set up and given their recommendation, like the Mahelkar Committee- CDSCO. All these are now being taken into to form the Indian Medical Device Regulatory Act (IMDRA). The Indian Medical Devices Regulatory Act had come into force on December 31, 2009 and the inputs of which are to be given to Dr B Hari Gopal, advisor Department of Science and Technology, New Delhi. 

India’s Central Drug Standard Control Organisation (CDSCO) has Central Licensing Authority (CLA) and State Licensing Authority (SLA) with responsibility for Licensing to Import, Manufacture for sale or for distribution and sale, stock, exhibit or offer for sale. CLA is responsible for all Import Devices Licensing and Class C & Class D Medical Devices Manufacturing, Loan and Wholesale Licenses. SLA is responsible for Class A & Class B Medical Devices Manufacturing, Loan and Wholesale Licenses.

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  1. Background 

Earlier manufacturers could sell medical devices in India without any jurisdictions. Since 2006, medical device regulations have been put forth by the Indian government through the CDSCO where all the devices entering the country must be in compliance with the set protocols. The CDSCO is responsible for medical device registration and regulation of any clinical trials of new drugs, laying down the standards for drugs, control over quality of imported drugs, coordination of the activities of the State Drug Control Organizations and providing expert advice with a view of bringing about uniformity in the regulation of medical devices. 

  1. Notified medical devices 

For registration of medical devices in India, 21 devices categories have been listed as ‘Notified Medical Devices’ by the CDSCO. However, devices that need registration extends beyond the categories mentioned. 

  • Determine if Product Requires Registration 

  • Appoint an Authorized Indian Agent 

  • Submit the Regulatory Dossier under Form 40 

  • Obtain registration Certificate in Form 41 

  • Obtain Import License in Form 10 

  • Product Marketing 

How can GPC help you?

  • Identification of compliance requirements under various guidelines including all data requirements.​ 

  • Data gap analysis and pre-assessment support​ 

  • Technical documentation support​ 

  • Pre and post submission support and technical liaison with authorities. 

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