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MoHFW Circular on Class A & B Medical Devices under Licensing Regime

calendar15 Oct, 2022
timeReading Time: 5 Minutes
Class A & B Medical Devices

The Government of India, Central Drugs Standard Control Organisation (CDSCO) and the Ministry of Health and Family Welfare (MoHFW) have issued a circular on regulations of Class A & B Medical Devices under Licensing Regime on 30th September 2022. This Circular is in reference to the notification G.S.R. 102 (E) dated 11th February 2020, i.e., commonly known as Medical Devices (Amendment) Rules, 2020, where it is mentioned that such Medical Devices will be under the licensing regime from 1st October 2022. 

Circular on Class A & B Medical Devices under Licensing Regime

The Circular issued on 30th September 2022 by the Governemnt of India, CDSCO, MoHFW[1] is in order to regulate all the medical devices mentioned under the G.S.R. 102 (E), where it was stated that the Class A & B Medical Devices would be under Licensing Regime from 1st October 2022. 

It states that in the meantime, many representations from different Associations and Stakeholders have been received where they have requested that the continuing business must not be disrupted due to implementation of this “Class A & B Medical Devices under Licensing Regime” with effect to 1st October 2022. And considering the same, it is decided that if an importer or manufacturer who is already importing or manufacturing any Class A & B Medical Device and has submitted an application for the same to the Central Licensing Authority or State Licensing Authority on or before 30th September 2022 under the provision of Medical Device Rules, 2017. Then the said application is deemed valid, and the importer or manufacturer can continue to import or manufacture such a medical device for more six months from the date of issue of the order or till the time the Central or State Licensing Authority takes a decision on the same application, whichever is earlier. 

Grace period for Class A & B Medical Devices under Licensing Regime

The Circular, released on 30th September 2022, provides a grace period for an import license to all non-regulatory Class A & B Medical Devices. This Circular came a day before the deadline outlined in Notification, G.S.R. 102 (E) of 11th February 2020, which states that all Class A & B Medical Devices must have an Import License before importation into India. 

Considering the new circular related to all Class A & B Medical Devices under Licensing Regime, this grace period ensures that the non-regulatory Class A & B Medical Devices that are presently registered and have a pending import license application as of 30th September 2022, can be imported and marketed for another six months while such applications are reviewed. 

The Class A & B Medical Devices under Licensing Regime was supposed to be done from 1st October 2022. However, the grace period has given additional time to the manufacturers of such medical devices to obtain their import licenses. It has been done to ensure no interruption to medical imports in India.   

Introduction to Class A & B Medical Devices under Licensing Regime

Following is the list of Class A & B Medical Devices that come under this Circular of MoHFW:

Class A Medical Devices:

The table here lists all the Class A medical devices out of the Class A & B Medical Devices under Licensing Regime from 1st October 2022:

Device Category Device Name
Catheters Nasopharyngeal Catheter or Nasopharyngeal
Disposable Perfusion Sets Y-Connector as an accessory to perfusion sets
Surgical Dressings Surgical Dressings
Surgical Dressings Bolster suture
Surgical Dressings Umbilical occlusion device
Surgical Dressings Alcohol swabs

Class B Medical Devices:

Following table enlisting all the Class B Medical Devices out of the Class A & B Medical Devices under Licensing Regime from 1st of October 2022:

Device Category Device Name
Catheters A-V Shunt or Fistula Adapter
Catheters Fibreoptic Oximeter Catheter
Catheters Forceps, endoscopic
Catheters Transcervical (Amino-scope) Endoscope and accessories
Catheters Vessel dilator for percutaneous Catheterisation
Catheters Cervical drain
Catheters Tracheobronchial Suction Catheter
Catheters Tracheostomy tube or tracheal tube
Catheters Biliary stone retrieval basket
Catheters Rectal balloon
Catheters Vial adapter
Catheters Oesophageal obturator
Catheters Suprapubic, non-disposable cannula
Catheters Angiographic Catheter
Catheters Suction tip and Catheter
Catheters Gastric, colonic- irrigation and aspiration Catheter
Catheters Balloon Catheter for Retinal Reattachment
Catheters Balloon dilation vessel Catheter
Catheters Balloon type Catheter
Catheters Arterial Catheter
Catheters Bartholin Gland Catheter
Catheters Bronchography Catheter
Catheters anaesthetic conduction Catheter
Catheters Cholangiography Catheter
Catheters Continuous flush Catheter
Catheters Continuous Irrigation Catheter
Catheters Coude Catheter
Catheters Double Female Urethrographic Catheter
Catheters De Pezzer Catheter
Catheters Eustachian Catheter
Catheters Epidural Catheter
Catheters Oesophageal Balloon Catheters
Catheters Guiding Catheter
Catheters Haemodialysis Catheter
Catheters Intravenous Catheter
Catheters Intramuscular Pressure Monitoring Catheter
Catheters Jejunostomy Catheter
Catheters Multiple Lumen Catheter
Catheters Nephrostomy Catheter
Catheters Nasal Oxygen Catheter
Catheters Peritoneal Dialysis Catheter
Catheters Rectal Catheter
Catheters Radiographic (non-vascular) Catheter
Catheters Retention type Catheter
Catheters Retention type Balloon Catheter
Catheters Straight Catheter
Catheters Single Needle Haemodialysis Catheter or Blood lines
Catheters Salpingography Catheter
Catheters Suprapubic Catheter
Catheters Subclavian Catheter
Catheters Umbilical Artery Catheter
Catheters Urethrographic Male Catheter
Catheters Urethral Catheter or Nelaton Catheter or Foley Catheter
Catheters Upper Urinary Tract Catheter
Catheters Chorionic Villus Sampling Catheter
Catheters Oximetry Catheters, Oximetry Pace port Catheter
Catheters Sclerotherapy Needle or Catheter
Catheters Water Jet Renal Catheter
Catheters Dialysate Tubing and Connector
Catheters Endoscopic Ligation Devices
Catheters Ultrasonic imaging Catheter
Catheters Flow Directed Catheter
Catheters Sclerotherapy Needle or Catheter
Catheters In-vitro Fertilisation or Embryo Transfer Catheter
Catheters Urinary Drainage Unit
Catheters Colon tube
Catheters Connecting Tube
Catheters Fluid Delivery Tube
Catheters Closed wound drainage tube or system
Catheters Decompression Tube
Catheters Double Lumen for intestinal Decompression or Intubation Tube
Catheters Feeding Tube
Catheters Oesophageal Blakemore Tube
Catheters Oesophageal Seng taken Tube
Catheters Gastrointestinal Tube
Catheters Gastro-Enterostomy Tube
Catheters Heart Lung Bypass Unit Tube
Catheters Levine Tube
Catheters Nephrostomy Tube
Catheters Nasogastric Tube or Ryles Tube
Catheters Orthodontic Tube
Catheters Rectal Tube
Catheters Stomach Evacuator (Gastric Lavage) Tube
Catheters Tracheal (Endotracheal) Tube
Catheters Tonsil Suction Tube
Catheters Closed Suction System
Catheters Orthodontic Guide Wire
Catheters Endolymphatic Shunt Tube
Disinfectants Disinfectants
Disposable Hypodermic Needles Aspiration and Injection Needle
Disposable Hypodermic Needles Angiographic Needle
Disposable Hypodermic Needles Biopsy Needle Kit
Disposable Hypodermic Needles Medication Injector
Disposable Hypodermic Needles Insulin Needles or Pen Needles for Insulin
Disposable Hypodermic Needles Blood Collecting Needles
Disposable Hypodermic Needles Bone Marrow Needle
Disposable Hypodermic Needles Cholangiography Needle
Disposable Hypodermic Needles Gynaecological Cerclage Needle
Disposable Hypodermic Needles Mammary Biopsy Needle
Disposable Hypodermic Needles Anaesthetic Conduction Needle
Disposable Hypodermic Needles Endoscopic Needle
Disposable Hypodermic Needles Emergency Airway Needle
Disposable Hypodermic Needles Epidural Needle
Disposable Hypodermic Needles Fistula Needle
Disposable Hypodermic Needles Gastro-Urology Needle
Disposable Hypodermic Needles Single Lumen Hypodermic Needle
Disposable Hypodermic Needles Prefillable Glass Barrel with Needle
Disposable Hypodermic Needles Pneumoperitoneum Simple Needle
Disposable Hypodermic Needles Oocyte Aspiration Needle
Disposable Hypodermic Needles Neurosurgical Suture Needle
Disposable Hypodermic Syringes Auto Disable Syringe for single use
Disposable Hypodermic Syringes Aspiration Syringe
Disposable Hypodermic Syringes Auto-disable (AD) syringes for immunisation
Disposable Hypodermic Syringes Irrigation syringes
Disposable Hypodermic Syringes Insulin Syringes
Disposable Hypodermic Syringes Traditional Single use syringe without safety feature (sterile hypodermic syringes for single use)
Disposable Hypodermic Syringes Sharp injury blood administration kits
Disposable Hypodermic Syringes Sharp injury protection (SIP) Plastic needle shield to be added to a syringe
Disposable Perfusion Sets Measured volume IV set
Disposable Perfusion Sets Sharp Injury Blood Administration kits
Disposable Perfusion Sets Transfusion or perfusion sets for single use
Disposable Perfusion Sets IV Flow regulator
Disposable Perfusion Sets Manifolds
Disposable Perfusion Sets 3 ways stop cock as an accessory to perfusion sets
Disposable Perfusion Sets Extension sets
IV Cannula Arterial Cannula
IV Cannula Coronary Artery Cannula
IV Cannula Intravenous Cannula
IV Cannula Haemodialysis Cannula
IV Cannula Venous Cannula
IV Cannula Vena Cava Cannula
IV Cannula Ventricular Cannula
IV Cannula Cannulate or Lymph Duct
Orthopaedic Implants Bone cap
Orthopaedic Implants Bone wire
Orthopaedic Implants Intra Osseous Fixation Wire
Orthopaedic Implants Plates, Clippers screws
Scalp Vein Set Scalp Vein Set
Surgical Dressings Surgical Staples
Surgical Dressings Surgical Dressings
Surgical Dressings Sterile Drapes
Surgical Dressings Cotton Grudges and bandages
Surgical Dressings Casting tapes or splint rolls
Surgical Dressings Surgical sealant
Surgical Dressings Ligature wire
Surgical Dressings Wound closure device

Conclusion

Concluding the Circular, which is related to all Class A & B Medical Devices under Licensing Regime. It is in reference to the notification issued by MoHFW, which stated that all the Medical Devices of Class A & B are supposed to be under Licensing Regime from 1st October 2022. It states that if there is an existing importer or manufacturer who is presently importing or manufacturing any of such devices and has submitted an application to the Central or State Licensing Authority on or before 30th September 2022 for obtaining the import or manufacturing license for the such medical device as per the provisions of Medical Devices Rules, 2017 then the said application will be deemed valid and such manufacturer or importer can continue to manufacture or import the device up to six months. 

Read our Article:How to Get CDSCO Medical Device Registration for IVD Lab Kits?

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