"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
The global medical devices market was estimated to be more than $ 200 bn in 2006.
And the Indian medical devices market was 2.6bn $ in 2006.
medical equipment market would grow to almost $5 billion by 2012 from $2.6 billion in 2006
Central : Central Drug Standard Control Organization (CDSCO).
-Referred as DCGI.
State: State Food and Drug Administration
-approx. 35 agencies in country.
(one agency in each territories/state)
Regulation for import medical devices
Foreign and Indian companies will have to apply for permission to import medical devices in India.
Both manufacturer and third party(agent) will have to register with CDSCO.
Indian importer or agent –obtain ‘no objection certificate’.
If the medical device is already approved by USFDA or CE -> Device registration in India will be trouble free.
Approval of the product from any other regulatory agency (Separate evidence for the approval from the each agency)
(i) US FDA clearance/approval.
(ii) EU medical device directive (CE Certificate).
(iii) Australia/Canada/Japan approval.
(iv) Approval in any other country.
Copy of ISO Certification if any for the manufacturing facility.
List of countries where the device is being sold.
List of countries where device is withdrawn from sale with reasons,
1500 US $ - Registration cost for site.
1000 US $ - Per medical device registration
Registration validity : 3 years
-Must apply for renewal before 09 months of expiration.
There is no specific time line for approval.
On March 1 ,2006. ten medical devices are categorized under drugs according to DCGI and have different basic regulatory processes from all other such products .
scalp vein sets
internal prosthetic replacements
In India, Following devices are under regulations,
disposable hypodermic needles
in vitro diagnostic kits for HIV
diagnostic x-ray equipment
disposable perfusion sets
Presently the Indian market for medical devices is largely unregulated.
Devices which do not need registration as drugs can be imported and sold freely .
clinical trials are generally not required for products approved in the US and EU.
For conducting a clinical trial of a device already in use in another country, trial record of 100 days is required to be submitted to the regulatory authorities of India.
Devices classified as drugs - must submit appropriate clinical data as part of the new drug application process .
Do not have marketing approval from an advanced country - DCGI might require Indian clinical trial data .
Any Regulated Medical devices can be imported by trial import license or T-License for clinical trial purpose.
Price control of drugs is controlled by the National Pharmaceutical Pricing Authority (NPPA), a completely separate body from the DCGI.
It has an elaborate system of drug price ceilings
The prices of devices are not controlled yet, but the government does have the authority to do so.