RegDesk Blog

India’s CDSCO Plans to Regulate High-End Medical Equipment and Implantable Devices

  The Central Drugs Standard Control Organization (CDSCO), India’s drug regulatory body, will soon regulate the manufacture, import, and sale of critical medical devices and equipment like pacemakers, X-ray machines, and MRI scanners. In May, the Organization’s Drugs Technical Advisory Board approved a proposal to define implantable devices and high-end...

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Organizations Push for Change of Clinical Diagnostics Regulations for FDA

By Jocelyn Black-Paul | June 1, 2018 Eighty one organizations, representative of patient advocates, providers, laboratories and diagnostic manufacturers, have reached out to Congress with a letter written on May 9.  The letter urged for them to “modernize the statutory oversight of clinical laboratory diagnostics, including laboratory developed tests (LDTs)...

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Australia’s TGA Delays Implementation of Regulatory Changes for 3D-Printed Devices

  Australia’s Therapeutic Goods Administration (TGA) has delayed the implementation of the regulatory changes that were proposed last November for the 3D-printing of medical devices. TGA halted this process after stakeholders expressed a need for further clarification on some of the terms in the proposed policy. Inquiries came from industry...

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Answers to Your Most Critical IVD Questions – India

The Medical Device Rules, 2017 went into effect the beginning of this year, January 2018.  Though the Act comprehensively covers “medical devices”, it failed to providing details for In Vitro Diagnostic devices (IVDs), digital health products, and software products. Recently, the Central Drugs Standards Control Organization (CDSCO) released a document...

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COFEPRIS’S AGENDA FOR 2018

COFEPRIS, the decentralized division of the Department of Health in Mexico, is the governing body for medical devices and medicines. COFEPRIS has officially joined the Pharmaceutical Inspection Cooperation Scheme (PIC/S), which bridges the most important regulatory agencies in the world. COFEPRIS plans on promoting regulatory policy that guarantees access of...

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