Home› India› Ministry of Health and Family Welfare› Notice regarding Medical Devices Rules,2017 Notification No....
Date: 2017-02-02 Category: Not Applicable State: Union Government Country: India

Notice regarding Medical Devices Rules,2017 Notification No. 78E

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

Executive Summary & Key Takeaways

What it means

  • This notice from the Central Drugs Standard Control Organization (CDSCO) announces the notification of the Medical Devices Rules, 2017.
  • The Medical Devices Rules, 2017 were officially published in the Gazette of India Extraordinary on January 31, 2017, via Notification No. 78 E.

Key Changes

  • The gazette serves as a formal announcement that the Medical Devices Rules, 2017 are now in effect.
  • Notification No. 78 E, dated 31.01.2017, contains the complete details of the Medical Devices Rules, 2017.

Impact Analysis

Medical Device Manufacturers

  • Action Items: Review the complete Medical Devices Rules, 2017 (Notification No. 78 E) to understand the new requirements for manufacturing, import, sale, and distribution of medical devices. Update internal processes and procedures to ensure compliance.

Importers and Distributors of Medical Devices

  • Action Items: Study the new rules to understand the changes in import and distribution requirements. Ensure that all imported and distributed medical devices meet the specified standards. Obtain necessary licenses and registrations as per the new rules.

Healthcare Providers and Hospitals

  • Action Items: Ensure that all medical devices procured and used meet the standards specified in the Medical Devices Rules, 2017. Update procurement policies to reflect the new regulatory landscape.

Regulatory Bodies (CDSCO and State Drug Controllers)

  • Action Items: Develop and implement enforcement strategies to ensure compliance with the new rules. Conduct inspections and audits of medical device manufacturers, importers, and distributors. Provide guidance and training to stakeholders on the new regulatory requirements.

Medical Device Associations

  • Action Items: Disseminate information about the Medical Devices Rules, 2017 to member organizations. Organize workshops and seminars to educate members on the new regulatory requirements. Work with CDSCO to address any concerns or challenges faced by the industry.

Key Entities Referenced

Central Drugs Standard Control Organization (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India, responsible for regulating the manufacture, import, sale, and distribution of medical devices. Medical Devices Rules, 2017: The new regulatory framework governing medical devices in India, aimed at ensuring the safety, quality, and performance of medical devices. Notification No. 78 E: The official notification published in the Gazette of India Extraordinary on January 31, 2017, containing the complete details of the Medical Devices Rules, 2017. State Drug Controllers: State-level regulatory authorities responsible for enforcing drug and medical device regulations within their respective states.
Official Source Record View Original Source →
See Full Document Text
No.21013/15/2017-DC Central Drugs Standards Control Organization Directorate General of Health Services Ministry of Health & Family Welfare (Office of DCGI) FDA Bhavan, Kotla Road, New Delhi-110002. Dated the 2nd February, 2017 NOTICE It is brought to the notice of all the stakeholders that the Medical Devices Rules, 2017 have been notified vide Notification No. 78 E, dated 31.01.2017, published in the Gazette of India Extraordinary on 31.01.2017. ( Arun Sharma) Director(A) Zones/Sub-Zones/Port offices/Laboratories, CDSCO. State Drug Controllers. Medical Devices & other Pharma Associations. 0/0 DCGI/PPS to JS(R). Website of CDSCO. Guard file.

Continue your research

Related Documents from Ministry of Health and Family Welfare