CLASS B MEDICAL DEVICE/IVD MANUFACTURING AND PRODUCT DEVELOPMENT SUPPORT

Class B Medical Devices / In-Vitro Diagnostic Kits

Class B medical devices have low to moderate risk to the patients and public health risks. Class B medical devices’ permissions or approvals are done by State Licensing Authority. The medical device under class B classification demands prior audit by a third party but doesn’t involve an official investigation. State Licensing Authority (SLA) designates a Notified Body to validate the requirements of the Quality Management System and Technical Review of Class B medical devices.

Class B Medical Device / IVD Classification –

As per the Medical Device Rule, 2022; here are medical devices that come under Class B medical devices classification.

Non-invasive medical devices which encounter wounded skin subject to sub-clause (c) or medical devices for directing or keeping substances referred to in sub-clause (a) shall be mentioned under Class B.

Non-invasive medical devices for deforming compositions of substances as mentioned in sub-clause (a) shall be defined in Class B.

Invasive medical devices for temporary or short-term use referred to in sub-clause (a) shall be mentioned in Class B if it has prospected,

• For external surfaces uses nearby any eyeball or it is subjected to be immersed by the mucous membrane.

Class B shall be assigned to Invasive Medical Device for short-term use following sub-clause (2), provided that the device is intended for such use:

• To be applied on external surfaces of any eyeball; or
• A mucous membrane may absorb this compound.

Under the new medical device regulations, Invasive (body orifice) medical products intended for long-term use shall be classified as Class B.

Active medical device that requires invasive (body orifice) connections shall be categorized as class B medical devices.

• Irrespective of its use duration
• If it is deliberated to be associated with an active medical device that is in Class B, C, or D.

Surgically invasive medical devices for short-term usage are subjected to sub-clause (b) to (g) proposed for temporary usage shall be defined under class B.

Surgically invasive medical devices for the temporary application are referred to under sub-clause (b), (d), and (e) determined for short-term use and shall be defined as Class B.

Surgically invasive and implantable medical devices for long-term usage shall be referred to class B by the MDR (Medical Device Rule), 2022.

Active therapeutic medical devices for supervising or interchanging energy Subject to sub-clause (b) shall be referred to Class B if it is intended.

Active diagnostic medical devices mentioned under sub-clause (b), (g), and (c), an active diagnostic medical device shall be determined to class B intended for,

• Provide energy that can be absorbed by the human body
• Take an image of radiopharmaceuticals in vitro distribution
• Monitoring or diagnosing vital phycological process

Medical devices containing medicinal products defined in sub-clause (a) shall be allocated to class B if it is determined to be placed into any tooth.

The medical device rules also define that Medical devices; utilized for sterilization or disinfection shall be determined to class B.

Class B Medical Devices List –

CDSCO is a division of MOHFW (Ministry of Health and Family Welfare) which is responsible for regulating medical devices of Class A / Class B / Class C / Class B under the Medical Device Rule, 2022 whether you are manufacturer or importer. All Class B medical device manufacturers must have a valid manufacturing license from the State Licensing Authority before Oct 1, 2022. 

CliniExperts has a decade of experience in providing end-to-end support and customized services based on the class B medical device / ivd manufacturers’ requirements. With this extensive industry expertise, we love to collaborate with various medical device and IVD manufacturers across India. 

CliniExperts assists medical device / IVD manufacturers to accomplish their goals of becoming self-sufficient in MD / IVD manufacturing through all means possible. 

CliniExperts Offers Different Types Of Support For Class B Medical Device / IVDs Manufacturers  Class B Medical device / IVD Product Development Support –

Feasibility and concept analysis of class B medical device

• Class B medical device product prototype to test and refine its functionality; initial product testing
• Class B medical product design and development, including verification and validation to ensure that outcome matches the specified design input 
• Final product validation of Class B medical device / IVD and launch preparation
• Class B MD/ IVD product launch in the market and post-launch assessment

Class B MD / IVD Facility Association & Designing as per MDR 2021(India) and cGMP (Current Good Manufacturing Practice)

•  Facility Design 
• Facilities Creation 
• Cleanroom for startup and Class B MD / IVD product validation 
• Class B medical equipment design and size

Documentation support to Create Class B MD / IVD plant master file and device master file 
Product quality management system 

• Class B Medical device ISO 13485 certification
• Offering support to act accordingly with the requirements of the 5th schedule of MDR 2022

Support to get a class B medical device / IVD manufacturing license from State FDA

• Documents as per the asked checklist 
• Gap analysis 
• Submitting the application
• Follow up and approval of the license

Class B Medical Device Audit and inspection Support

• Gap analysis 
• Support in Class B MD / IVD audit executed by notified bodies, registered with CDSCO under the provision of MDR 2021

Support for Class B new Medical Device / In-vitro diagnostic kits approval from CDSCO

• Shared checklist 
• Gap analysis 
• Application submission 
• Preparation for SEC meeting
• Clinical trial waiver

Biocompatibility testing is a critical component of the validation process of the medical device / IVD. To support class B medical device manufacturing, CliniExperts act as a Medical Device Authorized Agent and provide extensive support services aimed at class B medical device or in-Vitro diagnostic kits. 

We firmly work with medical device / ivd regulatory bodies, so we have a better understanding of their expectation during the audit or inspection.