Medical Devices Industry in Turmoil as New Law Restrains 200 Producers October 5, 2023 The medical devices industry is facing a crisis as more than 200 manufacturers have been compelled to halt the supply of their products due to the non-approval of their manufacturing licence applications under a recently implemented law before the cutoff date of October 1, 2023.
AstraZeneca India gets CDSCO Marketing Approval for Palivizumab, a Preventive Therapy for RSV October 4, 2023 AstraZeneca Pharma India, a leading biopharmaceutical company has received marketing approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute €˜Palivizumab injection 100 mg/ml (r-DNA origin) in India.
High-Risk Medical Device Manufacturers Halt Production Facing Regulatory Hurdles October 4, 2023 The recent regulatory changes dictate that medical devices categorised as class C and D, encompassing items such as ventilators, imaging equipment, oxygen therapy equipment, nebulisers, x-ray equipment, surgical robots, and oncology treatment linear accelerators, are prohibited from being sold without a valid manufacturing licence from October 1 onwards.
AiMeD Urges Govt to Extend Deadline for Medical Device Manufacturing Licence Amid Resource Constraints September 29, 2023 The Association of Indian Medical Device Industry (AiMeD) has once again appealed to the central government for an extension of the deadline for mandating manufacturing licences for Class C and D medical devices beyond October 1.
CDSCO Approves 9 More Medical Device Testing Laboratories Across India September 22, 2023 As per CDSCO, these laboratories conduct assessments and testing of medical devices on behalf of manufacturers, adhering to the guidelines specified in Form MD-40 under the MDR, 2017.
HiMedia Receives CDSCO Approval for Influenza PCR Detection Kit August 25, 2023 In a deal with BlackSoil, a prominent investment firm, GenWorks Health has received $4 million in funding. Through this investment, GenWorks Health can provide quality healthcare in underserved areas.