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.
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