Food and Drugs Administration, Haryana, India. |
Email ID: fdazone@gmail.com
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Last Updated on August 14, 2021 by The Health Master
FAQs on Medical Devices Rules, 2017
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:-
- Surgical Devices.
- Surgical Bandages.
- Surgical Staples.
- Surgical Sutures.
- Ligatures.
- Blood Bags.
- Condoms.
- Disinfectants.
- Insecticides.
- Stents
- Orthoimplants
- Intrauterine devices.
- Nebulizer w.e.f 01.01.2021.
- Blood Pressure monitoring devices w.e.f 01.01.2021.
- Digital Thermometer w.e.f 01.01.2021.
- Glucometer w.e.f 01.01.2021.
- All implantable medical devices w.e.f 01.04.2020.
- CT Scan Equipment w.e.f 01.04.2020.
- MRI Equipment w.e.f 01.04.2020.
- Defibrillators w.e.f 01.04.2020.
- Dialysis Machine w.e.f 01.04.2020.
- PET Equipment w.e.f 01.04.2020.
- X-Ray Machine and w.e.f 01.04.2020.
- 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.
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.
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 / 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…
Licensing procedure for Medical devices
Latest Notifications: Medical Devices
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