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Pankaj Tyagi
| Updated: 24 May, 2022 | Category: CDSCO

Classification of Medical Devices by CDSCO: An Overview

Classification of Medical Devices

CDCSO manages the affairs relating to the classification of medical devices. The same authority operates under the purview of the Drug Controller General of India. The Drugs and Cosmetic Act 1940 and Drugs and Cosmetic Rules 1945 constitute the regulatory framework for all medical devices in India. The Health Ministry of India has released the new medical devices and IVD regulations to improve the effectiveness of the Drugs and Cosmetic Act 1940. The said regulations came to effect on Jan 1, 2018.

An Overview of the New Medical Devices Rules India, 2017

  • The new rules mitigate the requirement of periodic renewal of licenses. Accordingly, the production and import licenses shall continue to stay valid till these are suspended or revoked or surrendered.
  • The entire licensing process shall be executed online via a dedicated online portal known as SUGUM. The said portal shall ensure seamless submission, tracking, and review of the registration documents. 
  • Regulators have already briefed out about the timeline of all the concerned activities. 
  • The said regulations seek to walk in tandem with the international regulations. 
  • The Sugam portal shall also provide the facility for change in granted registration. The applicant can access this facility via “Post Approval Change”. 

An Outlook on Regulatory Approvals Mechanism

The new regulation will bring the utilization of medical devices in line with international standards and mitigates the prevailing gaps. 

National Medical Device Authority shall hold the authority to advocate the domestic medical device market, which includes specific price limits, safety standards, and price control policy for related surgical devices. 

Presently, there are 22 notified medical devices listed under the Drug and Cosmetic Act, 1940, that seek mandatory Medical device registration from the CDCSO. 

Serial Number Devices name
1 Disposal Hypodermic Syringes
2 Disposal Hypodermic Needles
3 Disposal Perfusion Sets
4 In Vitro Diagonostic devices for AIDS, HbsAG, and HCV
5 Cardiac Stents
6 Drug Eluting Stents
7 Catheters
8 Intra Ocular Lenses
9 I.V. Cannulue
10 Bone Cements
11 Heart Valves
12 Scalpe Vein Set
13 Orthopaedic implant
14 Internal Prosthetic Replacement
15 Ablation Device

Classification of Medical device under the Medical Devices Rules

Medical devices listed under the new Rules “Medical Devices Rules, 2017” are categorized as per the Global Harmonization Task Force depending on associated risks.

  • Class A (Low Risk)
  • Class B (Low-Moderate Risk)
  • Class C (Moderate High Risk)
  • Class D (high Risk)

The authority granting regulatory consent with the registration of medical devices: 

Class B, C, and D: 

The Central Licensing Class A and B: The State Licensing authority shall deal with the licensing affairs relating to these classes. Further, the said authority shall also be liable to grant import and production licenses for products under Class C and D. Entities willing to deal with these entire classes can send the application to the State authority in the prescribed manner. 

The producers of medical devices shall be required to comply with risk proportionate regulatory norms cited under the Rules.

List relating to the Medical devices and their risk class 

The medical devices classification covers a wide array of devices in the grouping form such as stents and cannulas into more specific sub-groups such as coronary stents and ureteral stents. CDCSO has underpinned the classification of new sub-groups with risk analysis methods which are vital under the Medical Devices Rules, 2017[1].

 List relating to the Medical devices and their risk class

The medical devices classification covers a wide array of devices in the grouping form such as stents and cannulas into more specific sub-groups such as coronary stents, ureteral stents. CDCSO has underpinned classification new sub-groups with the aid of risk analysis methods which is vital under the Medical Devices Rules, 2017.

Class Medical Devices:

Serial No. Notified Drug/Device Category Device Name Risk Class General Intended Use
  Catheters Nasophayngeal Catheters/ Nasophayngeal Class A A Catheters (for adults) passed via nostrils and moved to depth of the nasopharynx to discard air choke or obstruction AResuscitator
  Surgical Dressing Surgical Dressing Class A Dressing aerosol, periodontal kit, non-adherent  dressing, dressing pad.
  Disposable perfusion set Y-Connector serving as an accessory to perfusion sets   It can be utilized to connect to a Catheter or a perfusion sets for infusion of contrast media etc.
  Surgical Dressing Bolster Suture Class A No-latex plastic bolsters are utilized to undermine pressure  of any non-permanent suture against the body the during the surgery
  Surgical Dressing Umbilical occlusion device Class A These devices might be a tie, clip, tape, or other item utilized to halt the blood vessels in the umbilical cord of new born infant
  Surgical Dressing Alcohol Swap Class A It is a single use, sterilise item comprising 70 percent isopropyl alcohol utilized for scrubbing & allowing drying & will fumigate needles access sites prior to use.

Class B Medical Devices

Serial No. Notified Drug/Device Category Device Name Risk Class General Intended Use
  Catherers Fibreoptic Oximeter Catether Class B Intended for tracking O2 consumption
  Catherers Forceps, endoscopic Class B Forceps is used to remove tissue  or foreign tissue from the gastrointestinal tract
  Catherers Cervical Drain Class B The device is utilized  to avert postoperative wound and respiratory distress
  Catherers Vial Adaptor Class B It is used to ensure multiple needless accesses to injection medication vials for withdrawal or transfer of fluid from the vial.
  Catherers Depezzer Catheter Class B A tabular, flexible device used for extraction of fluid from a body cavity
  Catherers Gastrointestinal Tube Class B A gastrotomy tube (aka G-Tube) refers to a tube inserted through the abdomen that supplies nutrition to the stomach
  Disposal Hypodermic Needles Pen needles for insulin/Insulin needles Class B Used to supply insulin for curing diabetes
  Disposal perfusion sets Measured Volume IV set Class B It is utilized in the management of fluid supplied via container into the patient’s vascular system via a vascular access device.
  IV cannulae Intravenous Cannula Class B The IV cannula refers to a passive device to facilitate for the infusion of drugs, fluids, and/or blood components, or to provide the placement of vascular access device
  Orthopaedic implants Bone Wire Class B Stabilization of fractured bony parts via surgical wires  

Class C Medical Devices

Serial No. Notified Drug/Device Category Device Name Risk Class General Intended Use
  Ablation Device Vein Ablation device Class C It is used for the treatment of source of varicose veins
  Bone Cements Bone Cement Class C It is used in arthoplastic procedures of the knee, hip and other joints for the fixation of metallic prosthetic implants  to living bone
  Cardiac Stents Bifurcation stent Class C Used to improve the side branch of luminal diameter of arterial bifurcation liasions
  Internal prosthetic eplacement Breast implant Class C Breast implant is utilized to augment the breast size
  IV Cannulae A-V shunt cannula Class C It is inserted into the patient’s blood vessels to provide repeated hemodialysis
  Orthopaedic implant Orthopaedic implants and accessories Class C Use to supersede the missing joint or bone or to bolster a hampered bone

Conclusion

CDSCSO’s new Medical device policy seeks to strengthen the Drug and Cosmetic Act by encompassing the above products. Continual research for better treatment has flooded the health care sector with new medical devices that are being used without any regulation. The new medical device policy seeks to fix this gap by constituting comprehensive legal fencing to protect the public interest. Do not forget to write up for any queries regarding the Classification of Medical devices. We will glad to respond.

Read our Article:Cosmetic Product Manufacturer License in India

Pankaj Tyagi

Pankaj has a diverse experience of writing research papers, blog, and articles during his college time. Earlier, he was working as a tax consultant in a financial firm, but his interest in writing drives him to pursue a career in the writing field.

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