India Medical Device Regulations - Update - 2017

[fialor]

As some of you may be aware, India has published new medical devices regulations (yes - after the decade long wait!). It was published in the national gazette on the 31st of Jan this year. Link to the CDSCO site is below.

http://www.cdsco.nic.in/writereaddata/Medical Device Rule gsr78E.pdf

As there is no very little time between now and the regulation coming into being - the 1st of Jan 2018 - I am interested in having a discussion about how others think this will be implemented, including how the requirements below will also be implemented:
1- combined in country India agent (regulatory role) and importer role - to
what extend will this be implemented?

2- for imported devices, will the combined agent role need to apply for a
licence to "manufacture/distribute" medical devices? or does the
manufacturer need to carry out the registration?

3- will the foreign manufacturer who is exporting into India need to engage
only with an agent who has a manufacturing/distribution license?

4- where does the NB come in - in terms of interpretation?

5- will all devices (which hitherto did not require registration) now require
registration, or approval of some sort? Who will provide the approval?

I am aware of the 4 classifications and the separation of class A, B, from C and D in the assessment process.

Lets have a healthy discussion!
Thanks

 

[Marc]

Thanks for the update.

 

[fialor]

As some of you may be aware, India has published new medical devices regulations (yes - after the decade long wait!). It was published in the national gazette on the 31st of Jan this year. Link to the CDSCO site is below.

http://www.cdsco.nic.in/writereaddata/Medical Device Rule gsr78E.pdf

As there is no very little time between now and the regulation coming into being - the 1st of Jan 2018 - I am interested in having a discussion about how others think this will be implemented, including how the requirements below will also be implemented:
1- combined in country India agent (regulatory role) and importer role - to
what extend will this be implemented?

2- for imported devices, will the combined agent role need to apply for a
licence to "manufacture/distribute" medical devices? or does the
manufacturer need to carry out the registration?

3- will the foreign manufacturer who is exporting into India need to engage
only with an agent who has a manufacturing/distribution license?

4- where does the NB come in - in terms of interpretation?

5- will all devices (which hitherto did not require registration) now require
registration, or approval of some sort? Who will provide the approval?

I am aware of the 4 classifications and the separation of class A, B, from C and D in the assessment process.

Lets have a healthy discussion!
Thanks

Update to the above.
Only manufacturers based in India require a license, or loan license to manufacture for sale or distribution.
Foreign manufacturers require an India Authorised Agent who will act as both the local regulatory person and import agent. The foreign manufacturers details are part of the Import license application that is required of the Authorised Agent.

It is also important to note that all medical devices are now part of the notification process either through the license to manufacture for domestic manufacturers, or foreign manufacturers via the import license.

The manufacture license/import license application process is 9 months, at least. Documentation burden is similar to the outgoing Notified Medical Devices List requirements.

 

[sriramsl]

Dear Filor,

Let me try to answer all your questions.

First, the Indian Medical Device Rule was notified on January 31st of 2017 with a 11 month time for Indian manufacturers and the Distributors to comply till 1st Jan 2018

1. Currently it is applicable only for 15 Notified Medical devices and not for all Medical devices
2. There is no combined "License" for manufacturer and Authorised agent for distribution. If a same company does manufacturing and also imports and sells, they have to get separate Licenses for each of the product being manufactured and separately for each of the product imported and sold
3.For a combined "entity" (manufacturer and agent) the registration of the company is obviously one time registration, but as explained above the License are for products
4. The foreign manufacturer who wants to sell products in India, has to engage with "a agent" and make an agreement as an exclusive authorised agent in India and that Agent NEED NOT be a manufacturer in India, but the License to "Import" the products of the foreign manufacturer will be issued to this "agent" and not the foreign manufacturer
5. The Role of the NB comes only for Class A and B products, for evaluation of the manufacturer for QMS (ISO 13485) as per 5th Schedule, the product evaluation and approval as per the requirement will be carried out by the Government appointed Officers under the control of competent authority. (We believe it may change to NB later once the amount of products are expanded, as it may not be possible for the Officers to cover all)
6. As stated above, currently only the 15 Notified products are under the rule, it is estimated by the end of 2018, it will be expanded to cover more products but will completely cover Class D and Class C products (by end 2018). All other products that are not notified can be sold as it is being currently being sold without any regulation.

These are the answers to your questions.

There are many intricacies in the Rule - needs to be understood thoroughly - for example, all products that are manufactured in countries other than - USA, Canada, EU countries, Japan and Australia - very few requirement for getting license. But for all other manufacturing countries - a complete evaluation as if it is manufactured in India. This is applicable even for say a US company manufactures the product in China - it will be considered as a China product and not as US product

Regards
Sriram

 

[noorain]

Can you please share the list of 15 devices you speak about

 

[sriramsl]

Dear Noorain

The list is attached here.
Also recently the Classification of these devices was announced, attaching the classification document also
Sriram

 

[noorain]

Dear Noorain

The list is attached here.
Also recently the Classification of these devices was announced, attaching the classification document also
Sriram

ECG devices are not part of the 15 regulated devices. Should we still get the manufacturing license, for manufacturing and distributing the same?

 

[sriramsl]

Dear Noorain
I have replied to the other thread for the same question.
Yes, ECG devices are not in the regulated devices as yet and we expect it to be included by middle of 2018.
Currently you don't need any manufacturing product license and for distribution, however as a normal process a manufacturing unit (any) need government clearances which is also called factory license - it is not product manufacturing license but for the factory.
For distribution (if imported) you need only the Import-Export code no for importing, but for distribution no license is required

 

[ernieto]

I have a question: do we need a license (India) for an IVD that is not listed on the "List of notified medical devices"? See attachment. Thanks

 

[sriramsl]

Dear Ernieto

No, You don't need a License for a Medical device that is not Listed (Not notified). Also "IVD instrument/device" is not Notified yet. The products under IVD are only the Strips and Reagents and not the Instrument.

Attaching the FAQ that gives the clarification on Question No 12, to be read along with the Question No 6 - the definition of IVD. Note it does not mention IVDD (In Vitro Diagnostic Devices)

Regards
Sriram