際際滷

際際滷Share a Scribd company logo

Medical Devices

Download as PPT, PDF
P
pviral24

The document discusses regulations around importing medical devices into India. It notes that the global medical devices market was over $200 billion in 2006 while India's market was $2.6 billion. Medical devices must be registered with the Central Drug Standard Control Organization and various state-level agencies. If a device is approved by the US FDA or bears a CE mark, registration is simpler. Registration costs $1500 for a site and $1000 per device, and is valid for 3 years. Certain devices are classified as drugs and have different regulatory processes. Clinical trials are generally not required for devices already approved in the US or EU. Import licenses are needed to import devices for clinical trials. While drug prices are regulated, medical device prices currently are

Convert to study materialsBETA

Transform any presentation into ready-made study materialselect from outputs like summaries, definitions, and practice questions.

1 of 15
Downloaded 81 times
IMPORT OF MEDICAL DEVICES TO INDIA -Viral Patel
Introduction What is Medical Devices? "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."
Market Value 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
Regulatory Bodies 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.
REGULATORY STATUS 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, if any.
Registration cost 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.
Regulation 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 . cardiac stents drug-eluting stents catheters intraocular lenses IV cannulae bone cements heart valves scalp vein sets orthopaedic implants internal prosthetic replacements
Continue.. In India, Following devices are under regulations, metered-dose inhalers disposable hypodermic needles syringes intrauterine devices in vitro diagnostic kits for HIV diagnostic x-ray equipment disposable perfusion sets sterilized sutures ligatures metered-dose inhalers
Continue.. 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 Trial 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.
Continue 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 .
Continue Any Regulated Medical devices can be imported by trial import license or T-License for clinical trial purpose.
Price Control 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.
Thanks

More Related Content

Medical Devices

  • 1. IMPORT OF MEDICAL DEVICES TO INDIA -Viral Patel
  • 2. Introduction What is Medical Devices? "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."
  • 3. Market Value 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
  • 4. Regulatory Bodies 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)
  • 5. 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.
  • 6. REGULATORY STATUS 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, if any.
  • 7. Registration cost 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.
  • 8. Regulation 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 . cardiac stents drug-eluting stents catheters intraocular lenses IV cannulae bone cements heart valves scalp vein sets orthopaedic implants internal prosthetic replacements
  • 9. Continue.. In India, Following devices are under regulations, metered-dose inhalers disposable hypodermic needles syringes intrauterine devices in vitro diagnostic kits for HIV diagnostic x-ray equipment disposable perfusion sets sterilized sutures ligatures metered-dose inhalers
  • 10. Continue.. Presently the Indian market for medical devices is largely unregulated. Devices which do not need registration as drugs can be imported and sold freely .
  • 11. Clinical Trial 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.
  • 12. Continue 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 .
  • 13. Continue Any Regulated Medical devices can be imported by trial import license or T-License for clinical trial purpose.
  • 14. Price Control 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.