IVDR Regulation EU 2017/746

Other Statutory Services

IQZYME offers a range of essential statutory services that help businesses comply with regulatory requirements across various industries, particularly in medical device and In Vitro Diagnostics (IVD) manufacturing. One of the key services is securing Factories and Boilers Permits, which are critical for ensuring that manufacturing facilities meet stringent safety, health, and environmental standards. These permits are especially important for companies involved in complex industrial processes, ensuring compliance with national and industry-specific regulations.

Import Export Code (IEC) Registration is another vital service for businesses engaged in international trade. Issued by the Directorate General of Foreign Trade (DGFT), the IEC is mandatory for importing and exporting products, including medical devices and IVDs. IQZYME also provides assistance with Legal Metrology Packaged Commodities (LMPC) Registration, which ensures that pre-packaged goods meet labeling and accuracy standards under Indian regulations. This is essential for avoiding customs issues and penalties, particularly for businesses in the medical and diagnostic sectors.

In addition, IQZYME offers FSSAI Registration, a necessary certification for businesses involved in the food industry. This certification, mandated by the Food Safety and Standards Authority of India (FSSAI), ensures compliance with food safety regulations. UDYAM Registration is another service provided, aimed at micro, small, and medium enterprises (MSMEs), helping businesses gain access to government benefits and schemes to support growth and operational efficiency.

Lastly, IQZYME facilitates the K-Smart Registration process, part of Kerala's e-governance initiative, which simplifies obtaining building permissions and approvals for medical device manufacturing and importing industries. This service enhances transparency and efficiency, ensuring businesses in the medical and IVD sectors can easily secure the necessary permits for smooth operations.

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