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
