FAQs on Medical Devices Rules, 2017

FAQs on Medical Devices Rules, 2017

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FAQs
Picture: Pixabay
Lalit Kr. Goel
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Q1:- What is the effective date of Medical Devices Rules, 2017 ?

Ans: 01 January 2018.

Q2. Which Devices come under Medical Devices Rules, 2017?

Ans: Mainly following Medical Devices come under these Rules:-

  1. Surgical Devices.
  2. Surgical Bandages.
  3. Surgical Staples.
  4. Surgical Sutures.
  5. Ligatures.
  6. Blood Bags.
  7. Condoms.
  8. Disinfectants.
  9. Insecticides.
  10. Stents
  11. Orthoimplants
  12. Intrauterine devices.
  13. Nebulizer w.e.f 01.01.2021.
  14. Blood Pressure monitoring devices w.e.f 01.01.2021.
  15. Digital Thermometer w.e.f 01.01.2021.
  16. Glucometer w.e.f 01.01.2021.
  17. All implantable medical devices w.e.f 01.04.2020.
  18. CT Scan Equipment w.e.f 01.04.2020.
  19. MRI Equipment w.e.f 01.04.2020.
  20. Defibrillators w.e.f 01.04.2020.
  21. Dialysis Machine w.e.f 01.04.2020.
  22. PET Equipment w.e.f 01.04.2020.
  23. X-Ray Machine and w.e.f 01.04.2020.
  24. Bone marrow cell separator w.e.f 01.04.2020.

Click here for list of medical devices category wise

Q3.Competent authority to issue license for category A & B Medical Devices?

Ans: State Drugs Controller (SDC) of the State.

Q4. Competent authority to issue license for category C & D Medical Devices?

Ans: Drugs Controller General India {DCG(I).

Also read: FAQs about New Drug, Banned drugs etc.

Q5. Who is competent to withdraw the samples of Medical Devices for testing & analysis ?

Ans: Medical Devices Officers notified by Centre or State as the case may be.

Picture: Pixabay

Q6: What is the status of certificate like GLP and GMP under Medical Devices Rules, 2017?

Ans: No such provision of GLP and GMP. Only QMS certificate will be issued by the concerned Licensing Authority.

Q7: Who is licensing authority to issue test license for Medical Devices ?

Ans: Drugs Controller General India {DCG(I) is the licensing authority to issue test license under Rule, 31 of the Medical Devices Rules, 2017.

Q8: Whether NOC from Pollution Control Board is required for setting up a Medical Devices manufacturing unit?

Also read: FAQs on Disinfectant: Must read

Ans: No, these products comes under green category as per Pollution Control Board.

Q9: Is there any provision of altering inscriptions on containers, labels or wrappers of Medical Devices once sold?

Ans: No such provision of altering inscriptions on containers, labels or wrappers of Medical Devices once sold.

Q10:  Who is the competent authority to issue special code under Medical Devices Rules, 2017?

Ans: Drugs Controller General India {DCG(I).

Q11: How much is the fee for one medical device with different brand names ?

Ans: Rs. 500/- each with different names.

Also read: FAQs – On ‘Good Night’, ‘All Out’, ‘Hit’ and ‘Harpic’ etc.

Q12: Who is the competent authority to approve Testing Laboratory under Medical Devices Rules, 2017?

Ans: Drugs Controller General India {DCG(I).

Q13: Whether bandage comes under Medical Devices Rules, 2017?

Ans: Bandages which do not come in contact with wound or injured skin or tissue or used for providing support / compression are not covered under the category of surgical dressings as per Medical Devices Rules, 2017.

Also read: FAQs – on Ranitidine tablets and injections in India

Q14: What are notified bodies?

Ans: Notified Bodies are team of expert registered with CDSCO under Medical Devices Rules, 2017 to carry out audit of manufacturing site for category A & B Medical devices under said Rules. At present there are 6 notified bodies.

Click here for list.

Q15: Who is the competent authority to issue certificates e.g. Quality Management System (QMS) / Market Standing Certificate (MSC) / Production Certificate (PC) / Free Sale Certificate (FSC) under Medical Devices Rules, 2017?

  • Ans:
  • -State Drugs Controller cum Licensing Authority for Category A & B medical devices.
  • -Drugs Controller General India {DCG(I) for C & D Medical Devices.

Q16: Is there any provision of approval of items without fee (as in formulation, where 10 items are free for approval per section) under Medical Devices Rules, 2017?

Ans: No such provision under Medical Devices Rules, 2017.

Also read: FAQs – On Narcotic Drugs, Brand Names of drug (G.S.R. no. 828 (E) dated…

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