Last Updated on January 6, 2024 by The Health Master
Rules for Medical Device Officers
The Union health ministry is taking steps to implement the new medical device (MD) regulations in India, which will come into effect on October 1, 2023.
As part of this process, recruitment rules for the appointment of medical device Officers are being developed. Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI), highlights the significance of the MD Rules 2017 in governing all medical device categories and risk-based classes.
This article provides insights into the upcoming changes in medical device regulations and the recruitment process for medical device officers.
Implementation of MD Regulations:
Current Status:
Manufacturers of Class A and B medical devices are already regulated under the new regime, having registered before September 2022.
Future Regulation:
Starting October 1, regulations will be in place for Class C and Class D medical devices.
Recruitment Rules for Medical Device Officers:
Amendments Underway:
The Union health ministry is in the process of amending the Recruitment Rules for Assistant Drugs Inspector (Medical Devices) within the Central Drugs Standard Control Organisation (CDSCO).
Stakeholder Input:
Comments were invited from stakeholders within a 30-day period following the notice issued by the Union health ministry in June.
Submissions can be sent to Room No.434-C, ‘C Wing, Nirman Bhawan, New Delhi-110011 or bikash.mahato@nic.in.
Eligibility Criteria for Medical Device Officers Position:
Academic Requirements:
Applicants should hold a bachelor’s degree from a recognized university or equivalent in one of the following fields:
- Biomedical engineering,
- Chemical engineering,
- Bio-technology,
- Mechanical engineering,
- Electrical engineering,
- Electronics and communication,
- Instrumentation engineering,
- Polymer engineering,
- Computer science engineering,
- Pharmacy,
- Pharmaceutical sciences,
- Medicine with specialization in clinical pharmacology, or microbiology.
Induction Training:
Successful completion of a mandatory induction training lasting at least two weeks is required for Direct Recruits as prescribed by the Central government.
Age Limit:
The maximum age limit for applicants is 30 years, with a relaxation of up to five years for government servants as per Union health ministry instructions.
Annual Capacity Building Plan (ACBP):
Introduction:
In May 2023, Union health minister Dr. Mansukh Mandaviya launched the Annual Capacity Building Plan (ACBP) to enhance the skills of civil servants within the Ministry.
Strategic Development:
ACBP aims to systematically develop Domain Competencies, Behavioral Competencies, and Functional Competencies among civil servants through a detailed Training Needs Analysis (TNA).
Collaboration:
The Capacity Building Commission, the Mission Karmayogi Cell of the Health Ministry, and all divisions within the department have collaborated to develop the plan.
Manpower Upgradation Proposal by Maharashtra FDA:
Current Manpower Constraints:
The Maharashtra Food and Drug Administration (FDA) has identified a shortage of drug inspectors, with only 80 serving as the field force in Maharashtra.
Compliance Challenges:
The limited workforce struggles to oversee approximately 90,000 drug retail stores and over 900 manufacturing units, leading to compliance issues.
Proposal for Manpower Upgradation:
In May, the Maharashtra FDA submitted a proposal to the state government, seeking manpower upgradation to address the existing gaps.
Sanctioned Posts:
Maharashtra has 161 sanctioned posts of drug inspectors, with an additional 21 in Mumbai.
Conclusion:
The Union health ministry’s efforts to establish recruitment rules for medical device Officers align with the forthcoming implementation of the new medical device regulations in India.
These developments aim to ensure enhanced regulatory oversight and compliance in the medical device sector, contributing to the overall improvement of healthcare standards in the country.
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