MEDICAL DEVICES REGISTRATION SERVICES
Permission to Manufacture or Import “NEW” Medical Device
NEW MEDICAL DEVICES- Devices without Predicate
New Medical Devices are those Medical Devices whose Predicate or similar product is not yet approved by the Central Licensing Authority of India i.e. CDSCO.
As per the New Medical Devices Rules 2017 and Regulations, a Clinical Investigation has to be administered to assess the safety and efficacy of the Proposed medical Devices.
Once the safety and Efficacy of the Device is proved to be Safe for Indian population , an application for Import or Manufacture of this Medical Device has to be filled with the CDSCO on Online Portal SUGAM.
The technical team at NKG ABC guides applicants, through this process and will helps them in obtaining the respective license for medical device for the above mentioned purposes.
Application Form :
The new Medical Device Rules 2017, have categorised the notified categories of medical devices into 4 broad categories based on the risk classification of respective products. In order to seek Permission to Manufacture or Import “NEW” Medical Device it is important to note the categorisation and correct forms so that we can ascertain the correct fee structure applicable for the grant of approval. The below table suggests that application form , approval form, fee structure based on the risk class of products.
|
Application Form |
Approval Form |
Risk/Class A,B,C,D |
Fees |
Licensing Authority |
|
MD 26- Application for grant of permission to import / manufacture for sale or for distribution of medical device which does not have predicate medical device |
MD 27- Permission to import or manufacture for sale or for distribution of medical device which does not have predicate medical device |
A,B,C,D |
Rs-50000/- |
CDSCO |
regulatory documents
A comprehensive checklist of documents has been issued by the regulatory authority which needs to be submitted for processing and grant of above permissions.
For a checklist of documents required for grant of Permission to Manufacture or Import “NEW” Medical Device in MD 27 for, please click here.
Timelines
That’s not all!
Once, a permission in Form 27 is granted in such a case, the below additional steps need to be undertaken:
Class A & Class B Medical Devices manufactured in India , manufacturers need to take further permission in Form MD 5 from the SLA. Please go through the regulatory documents and government fee for seeking permission in MD 5 from this link.
Class C & Class D Medical Devices Manufactured in India, Manufactures need to need to take further permission in Form MD 9 from the CDSCO. Please go through the regulatory documents and government fee for seeking permission in MD 9 from this link.
Class A, B, C, D Medical Devices Imported in India, Importers need to take further permission in Form MD 15 from CDSCO.Please go through the regulatory documents and government fee for seeking permission in MD 15 from this link.
Preparing regulatory documents is a time consuming and meticulous exercise. As an importer or overseas manufacturer , one is already engrossed in various business aspects prior to placing the product in India. If a mistake is made, it can lead to complete delay in regulatory gaps, business plan, overheads, financial planning issues as well as supply chain disruption.
WHY NKG FOR Medical Device Regulatory Services
NKG has a Dedicated and Efficient team of experienced regulatory professionals who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by providing clear and easily understandable requirements
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we help you meet your compliance needs
NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
