“The CDSCO has issued several classification guidance documents covering most medical disciplines to help the industry better classify their devices in India.”
Gunjan Verma
Managing Partner
Asia Actual India
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India’s CDSCO Updates Classification of Several Product Categories
Published on: October 30th, 2021
The Central Drugs Standard Control Organization (CDSCO), through a series of meetings with industry bodies have reviewed each category of their previously released draft list of 03 September 2020 and updated the list of risk classifications. This comes ahead of the conclusion of the Non Notified medical device registration period by 30 September 2022 and the initiation of the mandatory import license application process for the low and low-medium risk class medical devices from 01 October 2021 to 30 September 2022.
The updated list of the risk class of devices are based on the intended use, risk associated with Medical Devices and other In Vitro Diagnostic (IVD) Medical Devices and other parameters specified in First schedule of MDR 2017. The updated risk classification lists of medical devices pertain to: Neurological, Oncology, Gastroenterological, General Hospital, Pain Management, Nephrological And Renal Care , Personal Protective Equipment, Software, Operation Theatre, Dental, ENT , Interventional Radiology, Respiratory, Radiotherapy, Ophthalmology, Urology, Paediatrics and Neonatology, Obstetrical and Gynaecological, Dermatological and Plastic Surgery, Rehabilitation, Physical Support, Anaesthesiology, IVDs and Cardiovascular Under the provision of Medical Devices Rules 2017
These lists are being finalized with Industry Participation and wide stakeholder consultation. Due weightage is being given to the risk classification in the highly regulated geographies such as the USA, EU, Singapore, Japan and Canada. The original announcement on the classification of medical devices can be found here.
As of 30 September 2021, the Final lists have been released for the following Categories in July to September 2021:
India Classification Guidance Documents
NEUROLOGICAL
ONCOLOGY
GASTROENTEROLOGICAL
GENERAL HOSPITAL
PAIN MANAGEMENT
NEPHROLOGICAL AND RENAL CARE
PERSONAL PROTECTIVE EQUIPMENT
SOFTWARE
OPERATION THEATRE
ENT
RESPIRATORY
RADIOTHERAPY
OPHTHALMOLOGY
UROLOGY
PAEDIATRICS AND NEONATOLOGY
OBSTETRICAL AND GYNAECOLOGICAL
DENTAL
CARDIOVASCULAR
ANAESTHESIOLOGY – https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzQyNg==
DERMATOLOGY AND PLASTIC SURGERY https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzQ1Mw==
INTERVENTIONAL RADIOLOGY https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzQ1NA==
PHYSICAL SUPPORT https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzQ1NQ==
REHABILITATION – https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzQ1Ng==
IN VITRO DIAGNOSTICS (IVD) – https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzQ1Mg==
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Contact Asia Actual today with any questions on how these additional testing requirements may affect your market access to India.
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