NEWS ROOM

See the latest news from our company below or use the search feature. For more information, contact our head office or the Marketing Communications Manager directly at marcom@arazygroup.com.


 

INDIAN GOVERNMENT PUBLISHES NEW IVD & MEDICAL DEVICE RULES

by Arazy Group | Feb 22, 2017
India’s Ministry of Health and Family Welfare has finalized a new set of in vitro diagnostic (IVD) and medical device regulations, which will come into force on January 1, 2018.

The Medical Devices Rules, 2017
 will replace the country’s current Drugs and Cosmetics Act.

Licenses obtained before the implementation date will remain valid until their expiry date or July 31, 2018, whichever is later. Until the new rules are introduced, licenses will continue to be issued for a three-year period and a separate import license for importers will still be required.

Under the new rules, the Central Drugs Standard Control Organization (CDSCO) will retain the right to conduct a quality management system (QMS) audit of a manufacturing facility anytime during or after the registration process. Audits will be mandatory for India-based manufacturers but mostly need-based for foreign manufacturers.

Domestic companies producing low risk devices will need to pass a quality system audit conducted by a dedicated Notified Body that is assigned by India's Ministry of Health and Family Welfare. Foreign companies will need to be ISO 13485 certified by an EU Notified Body.

Contact us today to discuss the new rules in detail and to discover how regulatory intelligence and registration management system LICENSALE.COM® assists MedTech firms worldwide in gaining access to 100+ markets faster and more cost-effectively than ever before.
 
 
 
 
 
 

 

 

Back to Press Room

latest news
  • Sep 19 2017
    REGULATORY UPDATE - SPD

    Korea: SPD's CB11 was approved for sale with LICENSALE.COM®. ...

    Read More
  • Sep 6 2017
    REGULATORY UPDATE - SPD

    Philippines: SPD's IVD products CBDOT were approved for sale with LICENSALE.COM®. ...

    Read More
  • Aug 31 2017
    REGULATORY UPDATE - CORTEX

    USA: Cortex's Dental implants and Prosthetic Devices were approved for sale with LICENSALE.COM®...

    Read More
  • Aug 10 2017
    REGULATORY UPDATE - SPD

    Ethiopia: SPD's CB11, CB9 & CBDOT were approved for sale with LICENSALE.COM®. ...

    Read More
  • Aug 8 2017
    REGULATORY UPDATE - XERIDIEM

    Saudi Arabia: Xeridiems' Entuit family was approved for sale with LICENSALE.COM®. ...

    Read More

VANCOUVER OFFICE

  • Phone +1 604.681.6888
  • Fax +1 604.681.6822
  • info@arazygroup.com
  •  
  • #350-1333 Johnston Street
  • Pier 32, Granville Island
  • Vancouver, British Columbia
  • Canada V6H 3R9

BACK TO TOP