Indian Medical Device Regulation may be passed by this Aug 2011

#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.
 
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M

Mickey1102

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

Kind regards,
Mickey
 

somashekar

Leader
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 ?
 
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.
 
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