The Drugs Controller General of India (DCGI) issued a notice S.O. 648 (E) & GSR 102 (E) on 26th July 2021, regarding the classification of medical devices related to Dermatological and Plastic Surgery, according to the provisions of Medical Device Rules, 2017. The regulatory authorities have also mandated CDSCO Registration for Dermatology and Plastic Surgery Medical Devices. The list of devices was issued by the DCGI, which contains a list of 55 medical devices related to Dermatological & Plastic Surgery use. The Medical devices are categorized according to their risk classification. In this blog, we will discuss CDSCO Registration for Dermatology and Plastic Surgery Medical Devices.
CDSCO Regulation on Medical Device Rules, 2017
According to CDSCO, medical devices are classified into classes A, B, C and D based on the risk associated with the device, the intended use, and other requirements according to medical device rules, 2017.
Any person who wants to apply for registration of medical devices for import, manufacture, sale or distribution must follow the guidelines to be issued by the Ministry of Health and Family Welfare in the Central Government from time to time and must take into consideration the technological changes or development in the field of medical devices and in vitro diagnostic medical devices.
“A Medical Device can be any instrument, tool, apparatus, implement, machine, appliance, implant, and reagent for in vitro use, software, material, or any other related article,” according to the definition provided by the FDA.
A medical device can be one of two categories:
- Notified medical device
- Not Notified medical device
Before 2006, manufacturers could sell medical devices without restriction. They previously advertised medical devices without being subject to any rules or laws. Later, as a result of FDA policy, CDSCO created the Indian Medical Device Regulations, which mandated that the import and export of medical devices into India be governed.
The functions performed by CDSCO are–
- Medical Device Product Registration
- Setting up standards for Medical devices, Drugs, IVDs etc.
- Setting up laws, regulations, amendments and rules for Drugs, Medicines, Medical Devices, IVDs, etc.
- Regulating the market authorization of Drugs and Medical Devices.
- Regulating the Clinical Research and Drug trials in India.
- Approval of license to manufacture certain Drugs and other medicine-related devices
- Regulating the standard of imported drugs in India.
- Testing of Drugs through Central Drugs labs.
Risk Based Factors
The risks that medical devices possess are used as factors to categorize them. The use and purpose of a medical device determine how and why it is categorized based on its risks. A larger group of medical devices, such as cannulas and stents, are divided into smaller groups with more specific names according to CDSCO’s Different Classes of Medical Devices.
Indian Classification of Medical Devices:
Medical and IVD devices are categorized in India using various systems, each of which has four classes based on how dangerous the machines are. There are four different types of Indian medical devices listed in the table below:
|Medical device class||Risk level|
|Class-B||Low-Moderate level risk|
|Class-C||Moderate-High level risk|
Different Classes of Medical Devices have been divided into four different categories by the Medical Rules, 2017. Any business that aims to manufacture such devices for distribution or sale must submit an application to CDSCO for a Manufacturer’s Licence.
CDSCO Non-Notified Medical Device Classification
Earlier, only 37 medical devices were regulated by CDSCO. But in a recent notification, there has been a list of non-notified devices that falls under the definition of Medical Devices in India. The Ministry of Health and Family Welfare has recently made an amendment to the Medical Device Rules, 2017. According to a notice issued by CDSCO on 11th February 2020, it was notified that all medical devices are to be voluntarily registered with CDSCO before the given deadline. After the deadline, registration will be made mandatory for those devices. The deadline for voluntarily registering medical devices of Class A and B is 1st October 2022, and for Medical devices of class C and D is 1st October 2023.
CDSCO issued another notice on 3rd September 2020, where it included 24 non-notified medical devices for the purpose of registration. CDSCO Registration for Dermatology and Plastic Surgery Medical Devices is also a part of the list. The classification of 24 newly listed non- notified devices are-
|S.L. No.||Categories of medical device|
|5||Ear, Nose, Throat (ENT)|
|9||Operation Theater (O.T.)|
|13||Obstetrical and Gynaecological (O.G.)|
|17||Interventional and Radiology|
|19||Dermatology and Plastic Surgery|
|20||Paediatric and Neonatology Medical|
|23||Nephrology and Renal care|
Classification of Dermatological & Plastic Surgery Medical Devices
Following is the classification of Dermatological and Plastic Surgery Medical Devices:
|Sr. No.||Medical Device Name||Risk Class|
|2||Surgical camera and accessories||A|
|3||Implantable ligating clip||C|
|4||Laser surgical instrument for plastic surgery, general and dermatology||C|
|5||Low energy ultrasound wound cleaner||B|
|6||Non-powdered surgeon’s glove.||A|
|7||Surgical drape and drape accessories||B|
|8||Suture retention device||B|
|9||Ultraviolet lamp for dermatologic disorders||B|
|10||Wound autofluorescence imaging device||B|
|11||Battery-powered trephine system||B|
|12||Carbon dioxide laser||C|
|13||The colonoscopy, General & Plastic Surgery||B|
|14||Copper vapour laser||C|
|15||Cryosurgical unit and accessories||B|
|18||Dermatome skin approximation tape||A|
|20||Electrically powered trephine system||B|
|21||Electrosurgical cutting and coagulation device and accessories||C|
|22||Electrosurgical device for over-the-counter aesthetic use||B|
|23||Esophagoscope, General & Plastic Surgery||B|
|26||Gas-powered surgical saw||B|
|27||Gas-powered trephine system||B|
|28||Gastroscope, General & Plastic Surgery||B|
|29||General electrosurgical unit||C|
|31||Hydrophilic wound dressing||A|
|33||Internal tissue marker||A|
|34||Irrigating wound retractor device||B|
|35||A laparoscope, General & Plastic Surgery||B|
|38||Manual operating table and accessories and manual operating chair and accessories||A|
|40||Occlusive wound dressing||A|
|41||Plastic surgery osteotome||A|
|42||Powered corneal trephine||B|
|44||Powered suction pump||B|
|45||Removable skin clip||B|
|46||Removable skin staple||B|
|47||Reusable dermatome blade||A|
|48||Single-use dermatome blade||B|
|51||Soft tissue trephine||B|
|54||Surgical lamp Identification||A|
|55||Surgical microscope and accessories||A|
Documents Required for CDSCO Registration for Dermatology and Plastic Surgery Medical Devices
The following is a list of the requirements for CDSCO Registration for Dermatology and Plastic Surgery Medical Devices:
- Application Form
- Challan TR6
- ISO 13485
- Power of Attorney
- An Undertaking stating that only accurate information is provided
- Certificate of Quality Assurance
- C.E. Design Accreditation
- Declaration of Conformity
- Schedule D(I)
- Master Plant File
- Device Master File
- Free Sale Certificate
Procedure for CDSCO Registration for Dermatology and Plastic Surgery Medical Devices
The process for CDSCO Registration for Dermatology and Plastic Surgery Medical Devices in India is listed below. –
- Identify whether the medical devices need to be registered: To determine whether a medical device has been notified or not, the applicant must first check the Medical Devices and IVDs list. Before being marketed in India, all non- notified medical devices notified must first obtain voluntary registration before the given deadline.
- Medical Device Classification Based on Risk: Based on the risks associated, the medical devices must be registered with CDSCO.
- Indian Authorized Agent Appointment: In the case where the manufacturer is not Indian, an IAA, or Indian Authorized Agent, is appointed. The IAA represents the manufacturer in court and carries out all of their official business in India.
- Documentation procedure: To obtain a registration license, all required paperwork must be submitted to the appropriate authorities.
- Obtaining Registration and License: The manufacturer receives the registration license after submitting all required paperwork to the appropriate authorities.
Central Drug Standard Control Organization has issued a new risk-based Classification for CDSCO Registration for Dermatology and Plastic Surgery Medical Devices in India to comply with the latest Medical Device Rules in India. The notice was issued on 3rd September 2020, which listed that Dermatology and Plastic Surgery Medical Devices are to be classified as Non-Notified Medical Devices by CDSCO. The classification includes 24 medical devices. It is always advisable to connect with an experienced professional for CDSCO Registration for Dermatology and Plastic Surgery Medical Devices to save time and money wasted on any kind of failure.
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