The regulatory process for registering a Medical Device in India

shimonv

Trusted Information Resource
#1
Hi Fellows,
One of my clients in Israel asked me about the regulatory process for registering their product in India. It is a pain monitoring device.
From what I gather - submission is required for a very specific types of devices known as "Notified Medical Devices" and pain monitoring is not in that list.

Can anyone confirm this? It would be cool if no regulatory activity is required.

Best,
Shimon
 
Elsmar Forum Sponsor

mihzago

Trusted Information Resource
#3
Keep in mind that India is implementing new medical device regulations; the new requirements, including the classification are more in line with GHTF/IMDRF and jurisdictions such as Canada, Australia, Brazil, etc.
These new regulations are to take effect in January 2018, I believe, so keep your eye out for the changes.
 
Thread starter Similar threads Forum Replies Date
Q Posey Bed or Hospital Bed Regulatory Process Japan Medical Device Regulations 1
V Medical Device Regulatory Approval Process Charts ISO 13485:2016 - Medical Device Quality Management Systems 0
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 4 – Design Controls Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT De Novo Post-Mortem 3 - Rearranging the Regs Other US Medical Device Regulations 0
Watchcat Does Regulatory Affairs put the "no" in innovation? Other US Medical Device Regulations 14
Watchcat REGULATORY WATCHCAT De novo Post Mortem 2 - Disclosure and Accountability Other US Medical Device Regulations 11
Watchcat REGULATORY WATCHCAT De novo Post Mortem 1 - Regulatory Religion Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT De novo Post Mortem Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - RIP "Mini-PMA" Other US Medical Device Regulations 0
Q ISO 20417:2021- Regulatory Identification Other ISO and International Standards and European Regulations 2
Watchcat REGULATORY WATCHCAT - His Grandmother's Technology Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Samples & Labeling Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Clinical Investigations Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - The 510(k) Submissions Tracker Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Nonclinical Studies Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Benefits and Risks Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Special Controls and Standards Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Alternative Practices and Procedures Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Device Description Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Indications for Use Other US Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - General Comments Other US Medical Device Regulations 2
Ed Panek FDA Remote Regulatory Assessment (RRA) Overview 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
P Quality and Regulatory organizational structure Consultants and Consulting 2
M Supplier approved list - Notified body, regulatory body Supply Chain Security Management Systems 4
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
Watchcat REGULATORY WATCHCAT - De novo info updated and consolidated Other US Medical Device Regulations 0
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
A GPS Regulatory requirements? Manufacturing and Related Processes 6
C RA (Regulatory Assurance) Training (FDA) looking for resources Training - Internal, External, Online and Distance Learning 5
H SOP Template for seeking regulatory clearance - MDSAP Document Control Systems, Procedures, Forms and Templates 6
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
K Regulatory requirement of SaMD with machine learning component IEC 62304 - Medical Device Software Life Cycle Processes 3
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
D Worldwide Regulatory Knowledge Other Medical Device Regulations World-Wide 3
JoCam Rental, service & installation - regulatory requirements EU Medical Device Regulations 2
R Regulatory Affairs Certification (RAC) prep - Practice test versus actual exam Professional Certifications and Degrees 1
K Regulatory Affairs Certification (RAC) Exam - November 2020 preparation Professional Certifications and Degrees 0
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
A Regulatory requirements for electrical cosmetic appliances US Food and Drug Administration (FDA) 5
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
S RA (Regulatory Affairs) certification & Online Internship Professional Certifications and Degrees 11
S ISO 13485 Lead Auditor - Debate between our Quality Team and Regulatory Auditor - Internal Auditor Training ISO 13485:2016 - Medical Device Quality Management Systems 42
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 11
S Regulatory job in pharma vs. medical device US Food and Drug Administration (FDA) 16
S Regulatory job in pharma vs. medical device CE Marking (Conformité Européene) / CB Scheme 0
M Regulatory clearance pathways for surgical masks/N95 respirators Other US Medical Device Regulations 3
N "Placing on the market" & "putting into service"- one time regulatory event or Continual supply event? EU Medical Device Regulations 2
P MDR PRRC (person responsible for regulatory compliance) and personal liability EU Medical Device Regulations 3

Similar threads

Top Bottom