Saurangi Shah / 20th June, 2022

Manufacturing And Product Development Support For Class A Medical Devices/IVD’s

Regulation/Guidelines

Medical Device, IVD,

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Summary:

Get manufacturing and product development support for class a medical device/IVD’s by CliniExperts’ professionals including product development, facility association, documentation, quality management, manufacturing license, and audit and inspection support.

Class A Medical Devices / IVDs –

Class A medical devices / IVDs are medical equipment that has low risk to the patients and public health risks. Class A medical devices / IVDs are not deliberated to utilize in life-supporting or life-sustaining or of substantial significance in preventing impairment to human health, and these medical kits don’t have any potential contrary risk of illness or injury. Today, most medical devices come under the Class A classification.

Class A medical devices have minimal contact with patients and no to low effect on a patient’s overall health. In general, Class A medical devices or in-vitro diagnostic kits do not come into touch with a patient’s internal organs, central nervous system, or cardiovascular system. These medical pieces of equipment are subject to the fewest regulatory requirements.

Introducing Class A Medical Devices to The Market –

Introducing Class A medical devices is the fastest and easiest to bring to market since they have low risk to the patient’s health and are rarely critical to life-sustaining care.

Class A medical devices and IVDs are not exempt from CDSCO’s general controls, a series of commands which applies to Class A, B, C, and D medical devices. This act provides provisions to prevent adulteration, misbranding, registering devices, keeping records, and establishing good manufacturing practices. Manufacturers of Class A medical devices are still required to follow guidelines and implement quality management systems to ensure their products are of high quality.

To launch a device in the market, the manufacturer has to determine conformity with the Medical Device Rules, 2017 and compliance with the applicable general safety and performance requirements.

Class A Medical Devices List –

S. No	Medical Device Name	Intended Use	Risk Class
1	Aerosol Delivery tubing	This flexible tube is typically used alongside an oxygen mask, endotracheal tube (ET), humidifier, or nebulizer to deliver airborne humidification, usually to increase Oxygen levels.	A
2	Airway pressure alarm	A medical device associated with the breathing circuit to check the patients’ upper airway pressure during aided medical ventilation. If the ventilator pressure crossed the set limit; an audible or visual alarm triggers.	A
3	Airway protection face mask	To protect against respiratory diseases, this device is in the form of a flexible, form-shaped device worn over the nose and mouth. It protects in two ways – (i) source control by lessening the outflow and proliferation of respiratory viruses through airborne droplets and aerosols; (ii) wearer protection, diminishing the inhalation of airborne respiratory viruses.	A
4	Airway tube forceps	This hand-held medical device is used to grasp tubes for insertion and/or extraction into or from the airways, or to grasp objects that are obstructing the airways to remove them from them.	A
5	Dental excavator, reusable	It is a medical device, generally used to cut, clean out and shape a carious cavity before using filler.	A
6	Dental dressing forceps, reusable	During the application of a dental dressing to a patient’s oral cavity, this hand-held surgical device is used to grasp and hold the dressing in place.	A
7	Eye pad	The eye pad is a device consisting of an eye pad that is comprised of gauze, cotton, and other materials, meant to serve as a bandage over the eye for protection or comfort.	A
8	Surgical apparel	Surgical apparel is medical devices that are considered to be worn by operating room personnel during surgical procedures to preserve both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate.	A
9	ENT chair, mechanical	A medical device that supports a seated patient in a position that can be mechanically controlled, facilitates an examination, treatment, and/or minor surgery.	A
10	Hand-held urinal, female	An excretory container/set designed specifically for use by females (usually bed-bound) as a direct means of urinating, typically made of plastic.	A
11	Continuous Glucose Monitor Retrospective Data Analysis Software	A medical device or data analysis software for continuous glucose monitoring is intended to analyze and correlate data retrospectively obtained from the glucose tracking device.	A
12	Bulk oxygen concentration system	An assembly of medical devices has developed to concentrate medical grade oxygen (O2) from the air and then provide the concentrated O2, with the purity of up to 93%- 99.5%, to the hospital medical gas supply system for therapeutic use on patients in Hospital.	A
13	Automated lensmeter(Dioptometer)	The measurement of the focusing power (dioptric power) and some other optical properties of lenses such as spectacle lenses, contact lenses, or prisms using ophthalmic instruments.	A
14	Ankle/foot orthosis	Providing support, alignment, prevention, and/or correction of orthopedic deformities/injuries of the ankle and/or foot, or improving ankle and/or foot function.As well as decreasing foot pressure that affects foot circulation, it can help reduce diabetic foot ulcers and speed up the healing process after surgery.	A
15	Wall bars	For strengthening and training purposes or to regain and/or improve your body’s movement and balance, a medical device permanently attached to a wall can assist you.	A

Manufacturing And Product Development Support For Class A Medical Devices/IVDs

CDSCO comes under the MOHFW (Ministry of Health and Family Welfare) and continuously puts its efforts to regulate medical devices for manufacturers and importers of Class A/ Class B / Class C / Class D under the Medical Device Rule 2017. All Non-regulated Medical Devices and IVD manufacturers must have a valid manufacturing license from the respective State FDA on or before 1st Oct. 2022.

CliniExperts has years of experience and is offering end-to-end support or customization support based on the manufacturer’s needs and have sound expertise in this area and is willing to collaborate with various medical device / IVDs manufacturers across India.

CliniExperts is supporting manufacturers to achieve their objective of becoming self-sufficient in MD/IVD manufacturing through all means possible to accomplish their objectives.

CliniExperts offers different types of support for Medical Device / IVDs Manufacturers –

– Medical device product development support –
- Feasibility and concept analysis of product
- Product prototyping to test and refine the functionality; initial product testing
- Product design and development, consisting verification and validation to make sure that output matches the specified design input
- Final product validation and launch preparation
- Product launch in market and post-launch assessment
– Facility association & designing as per MDR 2017 (India) and cGMP (Current Good Manufacturing Practice)
- Facility Design
- Facilities Creation
- Cleanroom for startup and product validation
- Medical equipment design and size
– Documentation support to develop plant master file and device master file
– Product quality management system
- Medical device ISO 13485 certification
- Offering support to act in accordance with the requirements of the 5^th schedule of MDR 2021
– Support to get a medical device manufacturing license from State FDA
- Documents as per shared checklist
- Gap analysis
- Submitting the application
- Follow up and approval of the license
– Audit and inspection Support
- Gap analysis
- Support in product audit executed by notified bodies, registered with CDSCO under provision of MDR 2017
– Support for new Medical Device / In-vitro diagnostic kits approval from CDSCO
- Shared checklist
- Gap analysis
- Application submission
- Preparation for SEC meeting
- Clinical trial waiver

In terms of validation testing biocompatibility, every Medical Device IVD had its own set of compliance requirements. CliniExperts team offers a wide range of highly specialized and experienced services aimed at providing support for manufacturing class A medical devices / IVDs. Working closely with regulatory bodies allows us to better understand their expectations during the inspection.

Saurangi is a food regulatory expert with 8 years of experience. She shares her knowledge and insights on regulatory updates, food trends, best practices, and news. Follow her for expert insights and practical advice on all things for food regulatory

Saurangi Shah

CliniExperts Services Pvt. Ltd.

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