1. WCHorn

    US Citizen Traveling to Mumbai for Business

    I'm traveling to Mumbai for a short audit. I request some help from Covers that have made the trip. Health protection, city travel in Mumbai, negotiating the lines at the airport, converters/adapters for personal electrics, using credit cards and converting cash, tipping, business permits...
  2. Q

    Guidance on obtaining NOC from CDSCO India

    I have confirmed that the product we would like to market in India ( Medical device software) is not regulated by CDSCO; I need guidance obtaining No Objection Certificate from CDSCO. I found this guidance document attached but its not clear to me whether this is the same for MD? anyone with...
  3. D

    Notified body - CE Certification Class 2a Products in India

    Hi all, Am looking for Notified body for CE certification - Class 2a products in India, other than UL, DNV and TUV..
  4. bio_subbu

    Indian government issues guidance on Grouping Medical Devices in a Single Submission

    The Indian government issued two new guidelines on “Grouping Medical Devices in a Single Submission” and “FAQ on Grouping Guidelines issued under Medical Device Rules 2017” that allows applicants importing or manufacturing medical devices in India to group medical devices with “similar intended...
  5. T

    Waste Disposal - Medical Devices

    Hi..., Can you one please tell what the process/procedure to be followed for disposal of Medical Devices and Laboratory devices I understand that WEEE will apply for EU; Is that correct; Does anyone can share procedure or checklist for implementation of WEEE. Is there any other...
  6. bio_subbu

    India’s CDSCO Issues FAQ's on Medical Device Rule, 2017

    The Central Drugs Standard Control Organization (CDSCO) issues 13 pages guidance document on "Frequently Asked Questions on Medical Device Rule, 2017 (Doc No: CDSCO/ FAQ/ MD/01/2018)". A note from CDSCO that the replies to the FAQs are aimed only for creating public awareness about Medical...
  7. R

    India - EMS 14001:2015 Environmental product declarations

    Can anyone please send me simple document to address "Environmental product declarations" for our specialty chemical.
  8. A

    Add-On software for VMC to calculate setting time, Idle Time, OEE etc..

    Can anyone suggest Add-On software for VMC machine to calculate setting time, Idle Time, OEE etc.. Currently we calculating it by asking the operator to enter the data, & we are planning to automate it. We are based in India. Thanks in advance
  9. F

    India Medical Device Regulations - Update - 2017

    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...
  10. M

    INDIA - GSR 78 (E) - New Medical Device Rules - 2017

    Hi, can anyone inform us about these new rules GSR 78 (E) , for subcontractor or job worker to a licensed medical device manufacturer in India should the contractor / jobworker also require license or an ISO 13485 certificate is good enough . we cannot find the details in the rules . Firstly we...
  11. S

    The regulatory process for registering a Medical Device in India

    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...
  12. H

    Reusing Medical Devices in India

    Why reusing medical device is not considered as a crime in India?
  13. S

    Indian Medical Device Rule - January 29th, 2017

    Hi all Not sure if anyone has already started a thread on Indian Medical Devices Rule. On January 29th, 2017 the long awaited Medical Device Rule was released by the Ministry of Health and Family Welfare through the Gazette Notification. I had been a marginal contributor to this rule through...
  14. M

    How difficult is it to appoint a new Authorized Representative in India?

    How difficult is it to appoint a new authorized representative in India if the current AR is not cooperative?
  15. N

    Neutral Code Requirement - Medical Devices Outsourced from India

    Hi All, I hope someone could able to help me. We are in process of outsourcing IV sets from our approved supplier from India. It has been informed by the supplier that to export the IV set they need to place the Neutral code which is their Indian FDA license number to be stated on each...
  16. N

    How to calculate the Premium Freight charges

    Can someone guide me on how to calculate the premium freight charges for imported material in India? Should it be calculated on volume basis or value basis? please guide. regards, Gopalakrishnan
  17. somashekar

    NEPAL Earthquake - 26 April 2015

    NEPAL Earthquake and aftermath is now coming out as a worst ever disaster in the Himalayan terrain. World help sought Major parts of North India also having experienced the shocks and aftershocks over last 76 hours. Death toll over 3500 and loss / damages yet to be assessed.
  18. J

    Clinical Testing - NSR Device

    Dear Experts, My company located in the United States is making two kinds of devices: 1. Tonometer 2. Blood Glucose monitoring device We are planning to submit 510k applications. To support the indications for which we want clearance, we have decided to do clinical trials. My...
  19. B

    Register's Ownership in Iran, India, Jordan, Arab Saudi, Egypt

    Hi, please, I have a doubt about who is the owner of the medical devices's register in the following countries: Iran, India, Jordan, Arab Saudi, Egypt. Our company is not the manufacturer, but we are the marketer of the medical devices. :thanx:
  20. P

    For medical device regulations in India, do I follow CDSCO or BIS ?

    Regulation for Medical Devices in India is by standards required by BIS or as mentioned by CDSCO (Central Drugs Standard Central Organization) In CDSCO list few products are required to be notify but in BIS (Bureau of Indian Standards) many standards requirements are mentioned. Which we have...
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