Medical Device Registration process in India

Medical Device Registration process in India before manufacturers of certain medical devices can sell within India they need to be in compliance with India’s medical device regulations. Indian authorities overhauled the medical device regulatory process in 2017 with the publication of the Medical Device Rules. Previously, the medical devices manufacturers were free to sell their products in the Indian market without any regulation. Since 2006, the medical devices imported from overseas locations need to comply with Indian medical device regulations established by CDSCO.

The rules came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO), an agency of the Ministry of Health and Family Welfare. For an overview of the regulatory process, see or download the approval chart below. The Medical Device Registration process in India has become more complicated in recent years. In the past, medical devices did not need to be approved at all, but that is not the case today. In India, there are about 30 device “families” that outline which specific medical devices need to be registered.

Classes of Medical Devices

The medical devices in India have been categorized into four classes based on the criticality and risk they offer to the patients.

• Class A: Represent the low-risk category of the products such as thermometers, and tongue depressors.
• Class B: Represent moderate-risk products such as suction equipment and hypodermic needles.
• Class C: Represent moderate-high risk products such as bone fixation and lung ventilator.
• Class D: Represent high-risk products such as implantable devices and heart valve.

Medical Device Registration process in India

The registration process in India for imported devices is a re-assessment largely utilizing the same documentation and evidence required in the reference country review. 

Devices registered during the voluntary registration period benefit from a truncated application that involves administrative documents such as Free Sales Certificate from the country of origin, ISO 13485 certificate, as well as basic product information. The voluntary registration process carries no government processing fees but may be cancelled or suspended by the CDSCO for product safety concerns, or when superseded by the requirement for the mandatory Import License. 

The Medical Device Registration process in India is crucial for distribution purposes. The concerned authority would penalize any manufacturer who wishes to sell the product in unregistered condition.

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Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

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If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device   

Disposable general medical equipment

Disposable general medical equipment is any medical apparatus intended for one-time or temporary use. Medical and surgical device manufacturers worldwide produce many types of disposable devices. Examples include hypodermic needles, syringes, applicators, bandages and wraps, drug tests, exam gowns, face masks, gloves, suction catheters, and surgical sponges.

The primary reason for creating Disposable general medical equipment is infection control. When an item is used only once, it cannot transmit infectious agents to subsequent patients. One might think the most important factor in the design of Disposable general medical equipment is cost, but disposable medical devices require a careful balance between performance, cost, reliability, materials, and shelf life.

Benefits of Disposable general medical equipment

• Decontamination – Disposable medical tools ensure a contamination free instrument before each surgery. When a tool comes to the healthcare center pre-sterilized, the decontamination or lengthy sterilization process isn’t needed, therefore saving healthcare centers money.
• Traceability – Once a tool is used, disinfected, and put into storage, its cleanliness isn’t traceable. Disposable, one-time-use tools ensure the ability to account for all pieces of inventory and full traceability. The lot number that each piece has is able to be traced back to the medical manufacturing plant to prevent inconsistencies and issues.
• Supply Logistics – Inventory that is lost, broken, or stolen takes a significant amount of money out of the bottom line of a healthcare center. Single-use instruments allow for supply tracking and ensure there isn’t an abundance of one tool, which can tie up capital.
• Risk Management – Infection and the mitigation of spreading of diseases is one of the highest priorities in a medical facility. Contaminated instruments spread infection, create health issues, and can complicate surgical recovery. When instruments are used once, there is no risk of cross-contamination between patients.
• Cost Allocation – Accounting for each tool used in a surgery helps accurately calculate the cost of each surgery. When using reusable tools, the mix of initial cost, sterilization cost, labor cost, and utilities can make it difficult to accurately account for total cost of procedures.
• Waste – While many argue the amount of waste single-use tools create, the energy, water, detergent, steam, and electricity used to decontaminate reusable tools is more detrimental to the environment than disposable tools.

Advances in manufacturing and automation have decreased the production cost of many products, which has reduced their purchase prices. If this trend continues, products that are now considered too valuable to throw away will become so inexpensive that they will start to be considered Disposable general medical equipment. This could include electrical products and complex surgical tools. Furthermore, once these products are designed specifically to be single-use they can be made from cheaper materials and processes that will bring the price down even more.

Read More - Disposable general medical equipment 

Contact details –

Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

Read More Article - 

1. Orthopedic Implants Manufacturing

2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

5.How to start the Manufacturing of Disposable Syringes

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device