Central Drugs Standard Control Organisation is, known as CDSCO, is a regulatory body for the Indian medical devices industry, under the vittles of the Drugs & Cosmetics Rules, 1945 and Drugs & Cosmetics Act, 1940 and it’s the national regulatory body for Indian pharmaceutical and medical devices. Team Operon Strategist will help you in CDSCO Registration or DCGI approval for your products as per the guidelines of CDSCO.
Medical Devices entering to India must be in compliance with the Indian Medical Device Regulation set forth by the CDSCO. The CDSCO is responsible for the approval and regulation of New medicines and Clinical Trials in the Country, laying down the norms for medicines, control over the quality of imported drugs, collaboration of the activity of State Drug Control Organizations.
As per the new Guidance of CDSCO, suspense and cancellation of the Class A & B medical devices may be if importer fails to meet the deadline specified by CDSCO. CDSCO has set a complete procedure for granting license for medical devices imported in the country. This procedure is applicable when we import medical devices from other countries to India. still, they need to be classified according to CDSCO notified devices list, before manufacturer were suitable to sell their medical device in India without following any specific rules and regulations but from 2006, medical devices entering to India need to follow specific guidelines set by CDSCO.
How Operon Strategist Will Help You in CDSCO Import License?
Operon strategist is the leading medical device regulatory consulting company. We help our guests in making specialized dossier for the licensing process, we also solve the queries raised by the regulators, and we're delivering turnkey services, system implementation, training, licensing, regulatory approvals and certificates.
CDSCO issues Medical devices importing license under the Directorate General of Health Services in the Ministry of Health & Family Welfare. Speed up your import licensing process with us; Operon Strategist will assist you at every step of medical device importing license.
ALL IMPLANTABLE DEVICES, MRI AND CT SCAN EQUIPMENT NOW REQUIRE IMPORT LICENSES
With the release ofF.No. 29/ Misc/ 03/ 2021- DC( 28) on April 18th, 2021 the Central Drugs Standard Control Organization( CDSCO) now requires the following medical devices gain an Import License previous to importation.
All Implantable Medical Devices
CT Scan Equipment
MRI Equipment
Defibrillators
PET Equipment
Dialysis Machines
X-Ray Machines
Bone Marrow Cell Separators
CLASSIFICATION OF MEDICAL DEVICES
The medical devices are classified into the following 4 orders based on the risk involved in operation
Class A – low risk
Class B – low to moderate risk
Class C – moderate to high risk
Class D – high risk
The devices are further classified into Surgical andNon-Surgical based on their invasiveness.
NOTIFIED BODIES
Notified Bodies are Government accredited third- party authorities that are certified by the central licensing authority to review medical devices and check manufacturing spots to insure that they're conforming to the Quality Management System and other applicable protocols specified by the Bureau of Indian Standards.
GUIDELINES FOR IMPORT AND MANUFACTURE OF MEDICAL DEVICES
The Ministry of Health andF.W. under Gazette notificationS.O. 1468( E) dated6/10/2005 declared the following sterile devices to be considered as drugs under Section 3( b)( iv) of the Act.
Cardiac Stents.
Drug Eluting Stents.
Catheters.
Intra Ocular Lenses.
Cannulae.
Bone Cements.
Heart Valves.
Scalp Vein Set.
Orthopedic Implants.
Internal Prosthetic replacements.
It was also notified vide GSR 627( E) dated7/10/2005 that control over manufacture of these devices would be exercised by CLAA i.e. DCG( I) under the said Rules.
