Requirements for Marketing a Medical Device in India

[krishna007]

Dear Forum Members

Let me start by wishing you all a wonderful New Year!!

Would you be able to help on the requirements (documents, authorities) to sell/market a medical device in India. The complexity here is that the medical device has not gone in for any CE marking etc and hence might not entitle for a Free Sales Certificate. Still the device does not fall in any category listed by DCGI.

Thank you and eager to see your replies to the post.

Krishna.

 

[Ajit Basrur]

Dear Forum Members

Let me start by wishing you all a wonderful New Year!!

Would you be able to help on the requirements (documents, authorities) to sell/market a medical device in India. The complexity here is that the medical device has not gone in for any CE marking etc and hence might not entitle for a Free Sales Certificate. Still the device does not fall in any category listed by DCGI.

Thank you and eager to see your replies to the post.

Krishna.

Hi Krishna,

Wish you the same

Pl note that I have deleted your duplicate post from another section. If you have multiple posts, the responses wont be directed and your question will not be effectively answered.

Btw, I had the same question couple of months back and cound be found HERE

 

[Ajit Basrur]

Another one was Regulatory requirements for Medical Device Manufacture in India

 

[krishna007]

Hi Ajit

thank you very much for citing the other posts here. I believe most of the information that is provided in these websites are good enough. But there is a small clique in the requirement, that the manufacturing is going to be done in EU (&does nt have a CE mark), but would be sold only in India and for sure it does not come in those 10 devices (implantables) provided in the guidelines by Drug Controller General of India.

Do you think, it is enough just to produce general customs documents, like importer license, invoices etc or do you suggesst to call the DCGI??

Regards, krishna.

 

[Ajit Basrur]

How about you contact the DCGI office -

Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health and Family Welfare
Government of India
FDA Bhavan, ITO, Kotla Road, New Delhi -110002
Phone: 91-11-23236975
Fax: 91-11-23236973

 

[somashekar]

How about you contact the DCGI office -

Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health and Family Welfare
Government of India
FDA Bhavan, ITO, Kotla Road, New Delhi -110002
Phone: 91-11-23236975
Fax: 91-11-23236973

There is this CDSCO office in New Delhi and they have zonal offices in various regions like ex. South zone in Chennai. Again there is this State drug controller which is a state matter (Ex. The drug controller, Karnataka state) My experience is that usually these two government bodies are at loggerheads with each other and thus u have delays in processing of the license for import or manufacture, more so for the devices recently catagorised as drugs and needing license for import / manufacture. If you find that your medical device does not fall within the listed devices currently uploaded in the cdsco website which are termed as drugs, then you are free to import them into india with your other valid permits and legal imports procedure.

 

[krishna007]

Hi Somashekar

thanks for the repsonse. well as you have posted, this might seem more the case with the bereaucratic logs and for sure the product does not atleast fall in those 10 product categories defined by CDCSO as drugs..

and as Ajit has put it, may be it is better to contact the DCGI directly, but only worry is that we are not going to end up with more troubles..but it is worth trying though..

thanks

krishna

 

[bio_subbu]

Hi Somashekar

thanks for the repsonse. well as you have posted, this might seem more the case with the bereaucratic logs and for sure the product does not atleast fall in those 10 product categories defined by CDCSO as drugs..

and as Ajit has put it, may be it is better to contact the DCGI directly, but only worry is that we are not going to end up with more troubles..but it is worth trying though..

thanks

krishna

Hi Krishna

Have you verified the latest updates in CDSCO website, (Updated on 20th March 2009) The Indian Central drugs and standards control organization (CDSCO) has issued a clarification on the regulatory status of 19 medical devices that are accessories to, or variations of, products that require a license in order to be marketed.

Medical devices in India are generally regulated as drugs under the Drugs and cosmetic Act. Only the manufacturers of products that have been specifically classified as a medical device by a government notification are required to obtain a device license to manufacture, import or sell those products.

The CDSCO notice clarifies that the devices are also subject to such licensing requirements (please refer below CDSCO link /attachment).

http://www.cdsco.nic.in/clarification.doc

Also, there are plans to introduce a new Indian conformity Assessment certificate marking (or the IC mark), along the lines of the CE mark in Europe, for display on all marketed devices.

Thanks and Regards
S. Subramaniam,