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PIB 19th June 2021

CONTENTS

  1. ICMED 13485 PLUS
  2. EXERCISE EUNAVFOR

ICMED 13485 PLUS

Focus: GS II- Government Policies and Interventions

Why in news?

The Quality Council of India (QCI), and the Association of Indian Manufacturers of Medical Devices (AiMeD) have added further features to the ICMED the Scheme that had been launched for Certification of Medical Devices in 2016. 

 ICMED 13485 PLUS

  • The ICMED 13485 PLUS, as the new scheme has been christened, will undertake verification of the quality, safety and efficacy of medical devices.
  • It has been designed to integrate the Quality Management System components and product related quality validation processes through witness testing of products with reference to the defined product standards and specifications.
  • This is the first scheme around the world in which quality management systems along with product certification standards are integrated with regulatory requirements.
  • This scheme will be an end to end quality assurance scheme for the medical devices sector in India.
  • This scheme provides the much-needed institutional mechanism for assuring the product quality and safety.
  • It will go a long way in assisting the procurement agencies to tackle the challenges relating to the menace of counterfeit products and fake certification.
  • This will also help in eliminating the circulation and use of sub-standard medical products or devices of doubtful origin that could prove to be serious health hazards.
Quality Council of India (QCI)
  • Established in 1997 Quality Council of India (QCI) is an autonomous organization under the Department for Promotion of Industry and Internal Trade, Ministry of Commerce and Industry.
  • It aims to establish and operate national accreditation structure and promote quality through National Quality Campaign.
  • It is the Quality Apex and National Accreditation Body for accreditation and quality promotion in the country.
  • Chairman of QCI is appointed by the Prime Minister on recommendation of the industry to the government.

EXERCISE EUNAVFOR

Focus: GS III- Security challenges

Why in news?

Indian Navy is participating in the maiden IN – EUNAVFOR Joint Naval Exercise in the Gulf of Aden.

Exercise EUNAVFOR

  • EUNAVFOR is a multilateral naval exercise comprising of Italian Navy, Spanish Navy, and French Navy.
  • Ships of the four navies will endeavor to enhance and hone their war-fighting skills and their ability as an integrated force to promote, peace, security, and stability in the maritime domain.
  • EUNAVFOR and the Indian Navy converge on multiple issues including counter-piracy operations and protection of vessels deployed under the charter of the World Food Programme (UN WFP).
  • Indian Navy and EUNAVFOR also have regular interaction through SHADE (Shared Awareness and De-confliction) meetings held annually in Bahrain.
  • This engagement showcases increased levels of synergy, coordination, and inter-operability between India and EUNAVFOR.
  • It also underscores the shared values as partner navies, in ensuring freedom of seas and commitment to an open, inclusive and rules-based international order.
Mecca 
SUDAN 
ERITREA 
SAUDI ARABIA 
YEMEN 
Sanaa 
Aden 
ETHIOPIA 
Gulf of Aden 
SOMALILAND 
Addis Ababa 
o 
SOMALIA 
ulf of Oman 
Muscat 
OMAN 
Arabian 
Sea 
Socotra (Yemen) 
Indian 
Ocean 
NORTH 
250 
Kilometres 
l.ooo

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