Medical Device regulations in India are administered by the Central Drugs Standard Control Organization (CDSCO), under Directorate General of Health Services in the Ministry of Health & Family Welfare. The CDSCO serves as the National Regulatory Authority (NRA) of India.
To register a Medical Device in India, any non-local company must appoint a Local Agent or Manufacturer to interface with the CDSCO to ensure regulatory compliance.
Devices are categorized as either surgical or non-surgical based on their level of invasiveness. Obtaining a license for Class A devices is generally simpler than for Class D devices, which require more rigorous approval processes.
CE marking signifies that a product meets the essential requirements outlined in relevant European directives and regulations. These regulations establish the safety and performance criteria for products sold in the European Union (EU). For certain products, affixing the CE mark is a legal obligation.
CE marking is required only for products that fall under specific EU regulations that mandate it. Some products may be subject to multiple EU requirements simultaneously. Before affixing the CE mark, ensure your product complies with all applicable regulations. It is prohibited to use the CE mark on products for which no EU specifications exist or that do not require CE marking.
CE marking signifies that a product meets the essential requirements outlined in relevant European directives and regulations. These regulations establish the safety and performance criteria for products sold in the European Union (EU). For certain products, affixing the CE mark is a legal obligation.
Ensure Compliance:
Confirm that your product meets all applicable EU-wide requirements.
Assess Conformity:
Determine whether you can evaluate your product independently or if you need to engage a notified body.
Compile Technical Documentation:
Create a technical dossier that documents your product’s conformity.
Draft an EU Declaration of Conformity:
Prepare and sign this declaration.
Legal metrology refers to the application of legal standards to measurements and measuring equipment. In India, it falls under the jurisdiction of the Ministry of Consumer Affairs, Food and Public Distribution, specifically within the Department of Consumer Affairs. The primary objective of legal metrology is to ensure the safety and accuracy of weights and measurements, thereby providing the public with essential assurances regarding measurement integrity.
To register a Medical Device in India, any non-local company must appoint a Local Agent or Manufacturer to interface with the CDSCO to ensure regulatory compliance.
Under Rule 6 of the Packaged Commodities Rules (PCR) 2011, every packer is required to make the mandatory declarations specified in the regulations. When importing pre-packed commodities, it is essential to ensure that the packaging complies with PCR 2011 and the Legal Metrology Act 2009. Both the state and central governments have the authority to grant packer registration.
Any importer intending to distribute or sell pre-packed commodities must apply for packer or manufacturer registration under Rule 27 of the Legal Metrology Packaged Commodities Rules, 2011.
