Indian Medical Device Regulation may be passed by this Aug 2011

Ajit Basrur

Staff member
Admin
#1
According to Indian Medical Device Regulation may be passed by this Aug 2011

India’s medical device market is worth about US$3 billion and is ranked as the fourth largest medical device market in Asia, after Japan, China and South Korea. With a population of 1.2 billion people and a booming economy, there is increasing demand for medical devices, especially in the private healthcare sector. However, comprehensive guidelines on the standards and use of medical devices in India are still lacking. Certain medical devices are classified as drugs under the Drugs and Cosmetics Act and Rules (DCA), rather than actual medical devices. These include catheters, heart valves, cardiac stents, orthopaedic implants, bone cements and intra-uterine devices. There are many other medical devices which have not been clearly defined by the DCA.

Over the last five years, there have been proposals for a more-effective regulatory system to govern India’s medical device market. One of those proposals was the introduction of the Medical Device Regulation Bill. The bill was put forward by the Department of Science and Technology in 2006 for a comprehensive regulatory framework, specifically for medical devices. A Medical Device Regulatory Authority to regulate the manufacturing, marketing and use of medical devices in India was also proposed in the bill. The Medical Device Regulation Bill was intended for implementation by 31 December 2009, but it was not passed by the Council of States. Recently, however, there have been discussions of the bill being reintroduced in 2011. Many industry players are expecting its passage by parliament in July/August 2011. If implemented, the bill will provide a regulatory regime that differentiates between drugs and medical devices.
 
Elsmar Forum Sponsor
M

Mickey1102

#2
May I ask what the name of the DRAFT regulation being reintroduced in 2011 is?

Kind regards,
Mickey
 

somashekar

Staff member
Admin
#4
If it is passed, then what will be the implementation timeline ?
Is there a requirement of any mark on the devices by implementation time ?
As CE mark is so popular, is the CE mark having equivalent recognition, as an adopted mark ?
Will it have the license type of permits governed by CDSCO directly (major concern), or will there be other recognized registrars for grant of license ?
 

Ajit Basrur

Staff member
Admin
#5
Great questions Somashekhar.

In addition, I am not sure if there would be a system equivalent to "Establishment Registration"
 
R

RuthE

#7
Does anyone have any more information regarding the implementation timeline - what is the likilihood of these regulations being implimented?

Will there be any equivalent recognition for products aleady registered with FDA, Helath Canada, TGA (in Australia) or CE marked products?

Will implementation be staggered based on product classifications e.g. Class I or Class IIa (or A and B under Indian regulations) first then other classifications?

Are there any interim regulations in place for Class I and IIa medical devices?

There is no information addressing these questions on the Indian Ministry of Helath website.

Any comments are appreciated.
 
G

GPjeri

#8
Our distributor in India has sent the NEW/DRAFT regs and although draft is on every page, apparently the regs are now in effect. Has anyone out there put together a submission yet?? I'm about to dive into creating the likes of a master tech file to meet their requirements that inclue a Plant Master File, Device Master File, and a scedule DII -- this all for an IVD. I was hoping I could send our current Design Dossier, but that falls short. The information is more like a cross between a DD and a PMA. Any advice/help would be tremendously appreciated.

Thanks in advance,:thanx:
 
T

Tom Sha

#9
We submitted an registration application to DCGI at the end of September.
It contained covering letter, FSC, CE certificates, PMF, DMF, Schedule D(I) and (II), product label, and so on.
 
Thread starter Similar threads Forum Replies Date
M Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required? Other Medical Device Regulations World-Wide 12
S Indian Medical Device Rule - January 29th, 2017 Other Medical Device Regulations World-Wide 51
X Indian Medical Device Registration Requirements Other Medical Device Regulations World-Wide 6
somashekar Association of Indian Medical Device Industry information Other Medical Device and Orthopedic Related Topics 0
bio_subbu Indian government issues guidance on Grouping Medical Devices in a Single Submission Other Medical Device Regulations World-Wide 1
C Indian Labeling Requirements for Imported Medical Devices Other Medical Device Regulations World-Wide 9
L Do I need to have an Authorized Indian Agent to import Medical Devices into India? ISO 13485:2016 - Medical Device Quality Management Systems 5
R How to obtain OBL licence under Indian MDR, 2017 Other Medical Device Related Standards 2
Howard Atkins Happy Indian Independence Day Covegratulations 3
J Help in identifying Legal and other requirements for Indian localisation Miscellaneous Environmental Standards and EMS Related Discussions 4
A Indian IVD Regulations question - Schdule M IV Other Medical Device Regulations World-Wide 2
P Information on FDA approval for Indian Pharma companies requested Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
S Major Changes in Indian H&S Legislation - Info. for Indian Covers Occupational Health & Safety Management Standards 0
D Women in Employment - the Indian Situation Imported Legacy Blogs 10
D The Great Indian Greenwash Imported Legacy Blogs 4
Ajit Basrur Happy Dussehra to all Indian covers Coffee Break and Water Cooler Discussions 8
P Indian Auto major Tata motors planning to launch 2200USD cars World News 3
S ISO 9000 and First Nations / Aboriginal / Indian Groups ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Marc Indian Consortium To Offer 2 Mbps Internet Access At US$2.30/month After Work and Weekend Discussion Topics 9
K Regulatory Aspect of Embedding 4G/5G communication technologies into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
I Post-market surveillance and Post-market performance follow-up for in vitro diagnostic medical devices EU Medical Device Regulations 0
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
JoCam Accessories for medical devices EU Medical Device Regulations 5
G Medical Device Auditor (CMDA) certification exam by ASQ - looking for input Career and Occupation Discussions 3
M Prescription Form - Medical Devices US Food and Drug Administration (FDA) 0
XRAY_3121 Drop Shipping Legend Medical Devices Other Medical Device Related Standards 0
B Documenting Medical Device Complaints after End of Life? Medical Device and FDA Regulations and Standards News 0
M Medical Device License as Distributor Canada Medical Device Regulations 8
M Preparing a document for Raw Material of Medical Device EU Medical Device Regulations 1
R Medical device regulations in African countries Other Medical Device Regulations World-Wide 0
Jessesun The application of ozone sterilization in medical treatment US Food and Drug Administration (FDA) 0
A Production line for medical devices Other Medical Device Related Standards 1
S Design & Development records for Medical Devices Packaging and Labelling ISO 13485:2016 - Medical Device Quality Management Systems 8
K MHLW MO169 2021 Japan Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics Japan Medical Device Regulations 2
U Medical Devices Labeling Medical Device and FDA Regulations and Standards News 0
K Guidance on X-Ray Medical Devices for Animal Use - FDA US Food and Drug Administration (FDA) 0
Z Swiss Authorized representative & non-medical device regulations Other Medical Device Regulations World-Wide 0
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 1
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
dgrainger Informational Good news: Commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation EU Medical Device Regulations 3
P Brexit Germany - Import Medical Device For Clinical Study EU Medical Device Regulations 0
M Medical Device Marketing Material - Control of Social Media 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Ed Panek Make sure you hire competent QA RA Folks before making a "Medical Device." Coffee Break and Water Cooler Discussions 1
dgrainger Informational MDCG 2021-24 - Guidance on classification of medical devices EU Medical Device Regulations 0
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
S State Licensing requirements for Medical Devices sold in the US directly to hospitals and tissue banks 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 5
B ISO 11197, Venting of Medical Supply Units - cl. 201.11.2.2.101 Other Medical Device Related Standards 2
Q Best country to import medical devices into Europe Other Medical Device and Orthopedic Related Topics 0
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0

Similar threads

Top Bottom