Warning: session_start(): open(/opt/alt/php72/var/lib/php/session/sess_8f7b9b9b546714e21c71acfa19195660, O_RDWR) failed: Disk quota exceeded (122) in /home/shweuqjw/awajludhianaki.org/wp-content/plugins/jnews-social-login/class.jnews-social-login.php on line 83

Warning: session_start(): Failed to read session data: files (path: /opt/alt/php72/var/lib/php/session) in /home/shweuqjw/awajludhianaki.org/wp-content/plugins/jnews-social-login/class.jnews-social-login.php on line 83
Medical device certification scheme ICMED Plus redundant for SMEs, will hurt ease of doing business: MTal - Awaj Ludhiana Ki
Saturday, June 7, 2025
  • Home
  • National
  • International
  • Movies
  • Technology
  • Business
  • Fitness
  • Lifestyle
  • Punjab
  • Contact us
No Result
View All Result
No Result
View All Result
Home Business

Medical device certification scheme ICMED Plus redundant for SMEs, will hurt ease of doing business: MTal

by author
August 11, 2021
in Business
0
Medical device certification scheme ICMED Plus redundant for SMEs, will hurt ease of doing business: MTal
0
SHARES
35
VIEWS
Share on FacebookShare on Twitter


coronavirus in india live updates, covid19 latest news, Coronavirus Cases in India Latest Update, Covid-19 Vaccine Registration Online, covid variants latestThe scheme has been intended towards assisting the procurement agencies to tackle counterfeit products and fake certification challenges. (Image: Reuters)

Ease of Doing Business for MSMEs: The Indian Certification of Medical Devices (ICMED) scheme, which was rechristened as ICMED Plus in June this year to integrate the Quality Management System (QMS) components and device-related quality validation processes, is redundant and would impact the ease of doing business and investment opportunities for SMEs and other businesses, according to Medical Technology Association of India (MTal) that represents medical device and equipment industry in India.

Related posts

EXCLUSIVE – Crypto giant Binance controlled ‘independent’ US affiliate’s bank accounts

EXCLUSIVE – Crypto giant Binance controlled ‘independent’ US affiliate’s bank accounts

June 5, 2023
Why investing just to save tax may be bad for you

Why investing just to save tax may be bad for you

June 5, 2023

According to the association, the scheme has re-specified the requirements for QMS for medical devices in India which were already existing in Medical Device Rules (MDR), 2017, and ISO 13485. It maintained that the industry already takes the required regulatory approvals from the Central Drugs Standard Control Organisation (CDSCO) but is now facing the issue of multiplicity of regulatory authorities. ISO 13485 is the standard for a QMS to design and manufacture medical devices.

“The maximum number of companies in this sector is domestic SMEs. Though the government is striving to reduce their compliance burden as well as bringing in attractive incentive schemes for local manufacturing, such a redundant scheme will most destabilize only these small local companies. These SMEs which are already crippled by the pandemic will now have to jump a needless hurdle and incur avoidable costs before coming into the market,” Pavan Choudary, Chairman & Director General, MTal told Financial Express Online.

According to Choudary, despite having an established regulatory system (MDR) in place, the “quasi- certification schemes” such as ICMED Plus will confuse the budding entrepreneurs and burden SMEs. Moreover, such certification schemes increase unpredictability, thereby decreasing the attractiveness further, as the global interests are unsure of whether or not they will have to comply with new certification schemes as they enter India, the association had maintained.

Subscribe to Financial Express SME newsletter now: Your weekly dose of news, views, and updates from the world of micro, small, and medium enterprises 

The Commerce Ministry in a statement in June this year had noted that ICMED Plus is the first scheme in the world wherein the QMS 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.” Moreover, Quality Council of India’s (QCI) Secretary General Ravi P. Singh had said in the statement that ICEMED Plus was essential to be recognized as a “pre-requisite to show compliance by manufacturers under MDR-2017 and to reduce the load on regulators.” ICMED Plus was launched by QCI.

“ICMED Plus is voluntary product certification. Hence, there is no question of increased compliance burden for a manufacturer as he will seek it if he finds merit in it. Other countries do have voluntary certification in addition to regulations or to help regulators in reducing regulatory oversight such as European Union uses ISO/EN 13485, the US, Brazil, Canada, and Japan use MDSAP certification. The scheme allows Indian manufacturers to demonstrate compliance but on a voluntary basis as defined in India’s standards strategy launched last year in June,” Rajiv Nath, Managing Director, Hindustan Syringes & Medical Devices and Forum Coordinator, Association of Indian Medical Device Industry told Financial Express Online.

The scheme has also been intended towards assisting the procurement agencies to tackle counterfeit products and fake certification challenges along with eliminating the circulation and use of sub-standard medical products or devices of doubtful origin that might cause health hazards. “Currently around 22-23 medical device types are regulated and certified by CDSCO. How would you be sure of the quality of the rest of the devices? While there should not be a multiplicity of regulatory bodies but ICMED in the interim will play a fantastic role. The ideal situation would be to have ICMED amalgamated within the CDSCO certification process so that is only one medical device certification process,” Professor Amitabha Bandyopadhyay, Incharge — Innovation and Incubation, IIT Kanpur told Financial Express Online.

Get live Stock Prices from BSE, NSE, US Market and latest NAV, portfolio of Mutual Funds, Check out latest IPO News, Best Performing IPOs, calculate your tax by Income Tax Calculator, know market’s Top Gainers, Top Losers & Best Equity Funds. Like us on Facebook and follow us on Twitter.

Financial Express is now on Telegram. Click here to join our channel and stay updated with the latest Biz news and updates.





Source link

Previous Post

BJP-ruled DDA’s Master Plan 2041 is far from ground reality, alleges Somnath Bharti | India News

Next Post

Taliban can take over Afghan capital Kabul in less than three months: US intelligence | World News

Related Posts

EXCLUSIVE – Crypto giant Binance controlled ‘independent’ US affiliate’s bank accounts
Business

EXCLUSIVE – Crypto giant Binance controlled ‘independent’ US affiliate’s bank accounts

June 5, 2023
Why investing just to save tax may be bad for you
Business

Why investing just to save tax may be bad for you

June 5, 2023
Share Market outlook today: Nifty, Bank Nifty may to gain on positive global cues; check support, resistance
Business

Share Market outlook today: Nifty, Bank Nifty may to gain on positive global cues; check support, resistance

June 5, 2023
Startup group of G20 calls for $1-trillion commitment
Business

Startup group of G20 calls for $1-trillion commitment

June 5, 2023
DHARAKSHA: Converting rice straw stubble to sustainable packaging material
Business

DHARAKSHA: Converting rice straw stubble to sustainable packaging material

June 4, 2023
Amrita Hospital, Kochi opens two new research centres; announces Rs 65 Crore for charitable care
Business

Amrita Hospital, Kochi opens two new research centres; announces Rs 65 Crore for charitable care

June 4, 2023
Next Post
Taliban can take over Afghan capital Kabul in less than three months: US intelligence | World News

Taliban can take over Afghan capital Kabul in less than three months: US intelligence | World News

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

RECOMMENDED NEWS

12 OEMs receive fresh RFI for 1,700 FRCV

12 OEMs receive fresh RFI for 1,700 FRCV

4 years ago
Reopening of schools begin pan-India as per Covid protocols to address challenges of Covid infection in children

Reopening of schools begin pan-India as per Covid protocols to address challenges of Covid infection in children

4 years ago
14% Indians in 15-24 age group depressed: UNICEF | India News

14% Indians in 15-24 age group depressed: UNICEF | India News

4 years ago
Pinterest tests online events with dedicated ‘class communities’ – TechCrunch

Pinterest tests online events with dedicated ‘class communities’ – TechCrunch

5 years ago

BROWSE BY CATEGORIES

  • Animals
  • Architecture
  • Automobiles
  • Business
  • Culture
  • Fitness
  • International
  • Lifestyle
  • Movies
  • National
  • Sports
  • Technology
  • Travel

BROWSE BY TOPICS

Architecture culture Fitness indian architecture indian culture indian culture and heritage indian news lifestyle national news Technology technology news Travel travelling

About Us

Awaj Ludhiana Ki

Address

2667/3, Kishore Nagar, Tajpur & Jail Road, Ludhiana – 141008

Recent News

  • Rahul Gandhi Claims Maharashtra-Like Poll Rigging Will Happen In Bihar; BJP Hits Back With ‘Fake Narrative’ Jibe | India News
  • China To Give Pakistan Most Advanced J-35A Stealth Fighter With 400-KM PL-17 Missiles; How Will India Counter The Threat? | World News
  • Rekha starrer Umrao Jaan gets 4K re-release in cinemas from June 27: “None of us could have imagined the timelessness of the film” : Bollywood News
  • Thousands Gather Across Nation To Celebrate Eid al-Adha With Devotion & Unity | VIDEO | India News
  • India’s ‘Chenab Trap’ Chokes Pakistan’s Terror Route; Even China On Edge – Here’s How | World News

Category

  • Animals
  • Architecture
  • Automobiles
  • Business
  • Culture
  • Fitness
  • International
  • Lifestyle
  • Movies
  • National
  • Sports
  • Technology
  • Travel

Search

No Result
View All Result

Email

contact@awajludhianaki.org

  • About
  • Advertise
  • Careers

Copyright © 2019 Awaj Ludhiana Ki or it's affiliates | Website by Awaj Ludhiana Ki Team

No Result
View All Result
  • Home
  • Contact us
  • Animals
  • Architecture
  • Automobiles
  • Business
  • Culture
  • Fashion
  • Fitness
  • Food
  • International
  • Lifestyle
  • Movies
  • National
  • Sports
  • Technology
  • Travel
  • Punjab

Copyright © 2019 Awaj Ludhiana Ki or it's affiliates | Website by Awaj Ludhiana Ki Team

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In