CDSCO Notification

Central Drugs Standard Control Organisation – Notification dated 11th July 2022

In pursuance of notification No. G.S.R. 102(E) dated 11.02.2020, all non-notified medical devices of Class A & Class B categories are scheduled to enter licensing regime with effect from 01.10.2022

The Manufacturers are required to register their products on the portal (https://cdscomdonline.gov.in/NewMedDev/Homepage#) established for the purpose by CDSCO and to affix the registration number on the label of such registered medical devices.

All manufacturers are advised to apply for obtaining manufacturing license for Class A & Class B medical devices through CDSCO’s on-line portal so that the manufacturing license can be granted by respective State Licensing Authorities after review of the applications and audit (as the case may be) as per stipulated time specified in MDR, 2017 in order to avoid further delay.

CDSCO has also clarified that the quality certificates issued by any other entities shall not be a replacement of licensure to be granted under MDR, 2017 by the competent Licensing Authority. All manufacturers shall have to comply with the licensing requirement and obtain the license as per MDR, 2017, as the said rules do not recognize any such certificates which are not mentioned in it or part of it.

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc3MA==

Medical Device Regulations Update

No extension in deadline for registration of medical devices to manufacturers – Announcement from Union Health Minister

Medical Devices in India will come under the licensing regime from October 1 as notified by the Central Government. Class A and B Device manufacturers, importers have to in compliance with MDR 17 and should have Registration and Licensing in place before Oct 1 2022 to have market access.

Union Health Minister Shri Mansukh Mandaviya has stated in a recent press release that there will be no deferment of the deadline and urged all manufacturers to register their medical devices within the set timeframe. He also ordered the Central Drugs Standard Control Organisation to assist manufacturers who have not yet applied for registration for seamless process.

As per the rules, unregistered devices will not be deemed authorised and manufacturers may face penal action after Oct 1 , 2022. The registration will help in regulation of medical devices, establishing quality standards which will help in export of these devices and also make India an export hub for these devices soon.

Currently, only 37 medical devices such as cardiac stents, heart valves, orthopedic implants, catheters, X-ray machines and ultrasound equipment are regulated under the Drugs and Cosmetics Act, 1940, for safety, quality and effectiveness. A license is presently required to manufacture or import these 37 categories of medical devices

All 609 class A and 1,055 class B medical devices that are manufactured in India or are imported have to be registered and licensed by October 1 this year, while 596 class C- moderate to high risk and 87 class D- high-risk devices have to be registered by October 1 next year.

Source :
https://health.economictimes.indiatimes.com/news/policy/no-extension-in-deadline-for-registration-of-medical-devices-mandaviya-to-manufacturers/93112960?utm_source=twitter_web&utm_medium=social&utm_campaign=socialsharebuttons

PHDCCI Conference

Interactive Video Conference on Understanding ISO 13485 Certification for Medical Devices

Chandigarh Chapter, PHDCCI is organizing 5th in the MDR-17 Series| Interactive Video Conference on Understanding ISO 13485 Certification for Medical Devices as per the following schedule:

Day & Date: Friday, 15 July 2022
Time: 2:30 pm to 5:00 pm
Platform: Zoom

Session Highlights

• 7 Basic Quality Management Principles
• Overview of the Certification process and
• Importance of 13485 Certification from Compliance perspective

Key Speakers

• Mr. Mahadevan. J, VP & Business Segment Head – Medical, DQS India- Deutsch Quality Systems (India) Private Limited, Kodihalli, Bengaluru
• Mr. M G Sathyendra, Consultant & Trainer – Global Certifications, Qmart Global, Yeshwantpur, Bengaluru
• Mr. P.K.Minocha, Director, Meril Life Sciences Pvt. Ltd., Chala Gujarat
• Mr. Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED), New Delhi
• Col. Rajiv Bhargava(Retd.), Associate Director, Indian School of Business, Mohali

Please register in advance by clicking the link:
https://us02web.zoom.us/meeting/register/tZYtdOyspjsuGNEyI95QZr_wRhoB9giV413X

You may send your questions to rimneet.kaur@phdcci.in prior to the session. The relevant questions will be answered during the programme.

For any query, you may contact:
Ms. Rimneet Kaur, Resident Director, PHD Chamber
Mob:+91 81460 02297 | Email: rimneet.kaur@phdcci.in

Mr. Avneet Singh, Sr. Resident Officer, PHD Chamber
Mob:+91 8283848012 | Email: avneet.singh@phdcci.in

MDR 17 – An Interactive Session with Regulators

Industry, Startups & Innovators Support Session with Regulators on Licensing Requirements for Medical Device Manufacturers, Startups & Innovators in Tamilnadu – MDR 17

Session Topic : Ease Of Doing Business – Industry & Startups Support Session on Licensing Requirements – MDR 17

Date : 23rd July 2022 Saturday
Time : 3 pm – 5 pm
Meeting : Online Meeting

Program Objective:
Medical Device Industry in India is brought under full regulatory purview and industry has to show compliance to the Regulatory announcements made to this effect, from time to time.

Operators dealing with Risk Category Class A and B devices come under the purview of State Licensing Authorities and those dealing with Risk Category Class C & D devices come under the purview of Central Licensing Authority.

Medical Device Manufacturers, Innovators, Startups of Tamilnadu have requested for interactive sessions with Central and State Licensing Authorities and other stakeholders like BIS etc to guide them to implement the regulatory requirements better.

AIMED which is the voice for Indian Medical Device Manufacturers in the country and NHHID – Anna University , a National Hub for Healthcare Instrumentation Development, and Bureau of Indian Standards have collectively agreed to organize periodical sessions for the benefit of the industry and startups, innovators of Tamilnadu.

Target Audience

Medical Device Manufacturers, Innovators, Startups in Medical Device, MedTech space, Academia, Technology Business Incubators, Innovation Hubs, Medical Device Testing Laboratories, Healthcare services organisations – Hospitals, Diagnostics Centers , and other healthcare businesses, stakeholders to Conformity Assessment, Government organizations etc from Tamilnadu

Program Details:

Session would be conducted as Online Meeting, an interactive engagement with Manufacturers, Innovators, Startups .

There is NO REGISTRATION FEE. However , prior registration is a must.

For Enquiries about the Program :
Ms Rama Venugopal, Jt Coordinator,
AIMED – South India
jt.coordinator.south@aimedindia.com

Hub Co-ordinator
NHHID Hub, Anna University, Chennai
au.nhhid@gmail.com
For more details about the NHHID, Anna University , pls visit – https://www.nhhid.org

Medical Device Regulations

Indian Medical Device Rules 17 – Regulatory Affairs – Learning & Development Series

PWMAI – Preventive Manufacturers Association of India is creating online web series on Indian Medical Device Rules on the most frequently asked questions for the benefit of industry , stakeholders.

The Learning and Development Series will have short video sessions on wide range topics and subjects based on MDR 17.

Industry and all other stakeholders are requested to visit this page regularly for more updates, recent uploads.

TopicYoutube LinkCreated by
How to create User Registration in MD CDSCO Portal ?https://www.youtube.com/watch?v=klCBqt2akRcPWMAI
Creation of Undertaking to be uploaded in MD CDSCO portalhttps://www.youtube.com/watch?v=OYd-8BzCkck&t=33sPWMAI
What is MDR (Medical Device Rules) ?https://www.youtube.com/watch?v=Mbadl4a0DAM&t=153sPWMAI
Essential Principles for Medical Device Safety & Performancehttps://www.youtube.com/watch?v=RWPQkp_0C74PWMAI

About PWMAI

PWMAI– Preventive Wear Manufacturers’ Association of India is a team of people engaged in manufacturing of Preventive Wear products. Primary domain of manufacturers of this group is Surgical Gowns & Drapes which are used for infection control in Healthcare Settings.