May-June 2019

Medical Plastic Data Service Magazine



Our 27th Year of Publication
Page  1 of 4


Cover Story

Updates on Medical Device Regulations in India & Key Features Of Roadmap Ahead

Dr. V. G. Somani
Drugs Controller General (India)
Ministry of Health & Family Welfare,
Government of India


  • New online system for medical devices is functional for uploading the applications for Import License and Manufacturing License of Medical devices and IVDs, for post approval changes, registration of medical devices testing laboratories, clinical investigation etc.

  • Classification of Medical Devices and IVDs has been finalized in consultation with the stakeholders and uploaded in the CDSCO website.

  • New online system for Medical devices is functional for the registration of Notified Bodies. Six notified bodies have been registered and information is available on the CDSCO website. Grouping of Medical Devices and IVDs along with essential principle checklist has been finalized in consultation with the stakeholders and uploaded in the CDSCO website.

  • Notification of Medical Device Officer and Medical Device Testing Laboratories have been published.

  • CDSCO organised workshops to impart trainings various stakeholders including State Licensing Authorities for the effective implementation of Medical Devices Rules, 2017.

  • For addressing various questions on regulatory practices in medical devices, Frequently Asked Questions (FAQ) on medical devices and in vitro diagnostics is uploaded on CDSCO website. Also regular interactions are taking place with all the stakeholders to resolve their regulatory practices issues.

  • Guidance on Performance Evaluation of In-vitro Diagnostic Medical Devices have been published on the website.

  • Guidance document for stability study and post marketing surveillance of In Vitro Diagnostics is prepared and shared with the stakeholders for their comments.

  • Setting up of Public Relation Office at CDSCO (HQ), New Delhi will act as single window to guide, assist and providing information to the innovators regarding regulatory requirements. Function from 10:00 am to 5.30pm in all working days.

  • Launch of Support Cells for WHO PQS for IVDs in India for providing guidance to the Indian manufacturers for the WHO Prequalification of In Vitro Diagnostics Programme in India

1) National Institute of Biologicals in North India

Materio-vigilance Programme

  • Materiovigilance programme of India was launched on 6th July 2015 at Indian Pharmacopoeia Commission, Ghaziabad.

  • Indian Pharmacopoeia Commission functions as National Coordination Centre (NCC).

  • Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), Thiruvananthapuram act as National Collaborating Centre.

  • National Health System Resource Centre (NHSRC), New Delhi, act as Technical support partner

  • Central Drugs Standards Control Organisation (CDSCO), New Delhi, support MvPI with experience of functioning as National regulator.

Medical Device Testing Laboratory
Serial Number Name of Laboratory Category of Medical Device
1 The National Institute of Biologicals, Noida In-Vitro Diagnostics for human Immunodeficiency virus, Hepatitis B Surface Antigen and Hepatitis C Virus, Blood Grouping sera, Glucose Test Strip, Fully Automated Analyser Based Glucose Reagent
2 The Central Drugs Testing laboratory, Chennai Condoms
3 The Central Drugs Laboratory, Kolkata Surgical Dressings, Surgical Cotton, Surgical Bandages, Disinfectant
4 The Regional Drugs Testing Laboratory (RDTL), Guwahati Disposable Hypodermic Syringes, Disposable Hypoder-mic Needle, Disposable Perfusion Sets, I.V. Cannulae
5 The Central Drugs Testing Laboratory, Mumbai Intra Uterine Devices (IUD) and Falope Rings
6 SIPRA LABS LIMITED Sanathnagar, Hyderabad, Telangana-500018. Copper-T, Condoms ,Sterile Hypodermic Needles, Tubal Rings ,Hypodermic Syringes and Blood Bags
7 M/s, Star Imaging & Path Lab Pvt. Ltd. situated at 4B/4, TILAK NAGAR, West Delhi Delhi, Delhi - 110018 Bilirubin (Total and Direct), Creatinine test reagent / kit, Aspartate Amino Transferase, Alanine Amino Trans- ferase, Uric Acid Test reagents / kits, Total Protein test reagents /kits , Activated partial, PT (Prothrombin Time) Test
8 M/s Alcatec Research Laboratories India Pvt Ltd. situated at 1652 MIE Part B, Bahadurgarh, Haryana 124507 Sterilized Surgical Ligatures, Sterilized Disposable Device, Sterilised Surgical Sutures
9 Sree Chitra Tirunal Institute For Medical Sciences & Technology Medical College Thiruvananthapuram (India) - 695011

Cardio Vascular Devices, Neuroprosthesis, Orthopedic Implants, All medical devices and Materials, Dental Implants

Initiative taken by NIB, Noida

NIB, Noida also evaluate the following IVDs

  • Syphilis test kit

  • Blood glucose test strips

  • Dengue IgM ELISA

  • Chikungunya IgM ELISA

  • Blood grouping sera

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Proven Trade Contacts, India

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