How to Export Medical Devices From India
Hello everyone ,
Hope you all are doing well,
So here we discuss about How to export medical devices from India
So first we need to know about the medical devices
Q. What is a medical device ?
Ans – It is an apparatus , instrument and implant which is used to diagnose, to treat or to cure any disease . It include ,
- Surgical instrument – Scissor , Forceps , Scalpels etc
- Implant – Calipers , Elevators and Pacemakers
- Hospital instrument- Stethoscope , Reflex hammer , Radiography etc
Q. What is medical devices and drug ?
Ans– Both are used to cure treatment .
Drug– It is a chemical devices , In that you need to have pharmacology knowledge, clinical trial use in drug , drug are in solid , liquid and semisolid .
Medical devices- It is instrument , in that you have to knowledge about engineering ,clinical evaluation use in medical devices ,here is a type A ,B,C.D .
Class A- low risk devices-
- stethoscope
- Thermometer
- Spectacle
- Tongue depressor
- Inhaler
- Walking aid
- Bandage
Class B – low to moderate risk –
- Wheel chair
- Gloves
- Needles and syringe
- Hearing aid
- BP monitor
- Glucometer
- Nebulize
Class c- Moderate to high
- Hemodialysis
Class d- high risk –
- pacemaker and cardiac stent
- cardiac state
Benefit of medical devises export –
- Affordable cost
- high quality
- government support
- RODTP scheme
To register medical devices in India
- Manufactures and importer must register with the Central drug standard control organization (CDSCO) registration
- Obtain necessary licenses including an MD-14& MD-15 class import license for class A&B that is -M-14 and class C&D that is MD-15
- A Medical Devices Quality management system(MDQMS)-Ensure consistent product quality, safety and efficacy base on ISO
- labelling requirement – general, where applicable , instruction.
General labeling-
- Identification and manufacture information
- devices details
- tracking information
- operation Assurance
- preparation requirement
- safety information
- general labelling
- usage timeline
- storage and handling
- manufacturing date
Where applicable
- sterilization
- reusability
- radiation emission
- compatibility and interference
- usage restriction
Instruction labelling
- devices performance
- disposal risks
- incorporated substance
- accuracy and usage
- requirement
- environmental exposure
- medical interaction
Documentation required for medical devices export
- Free sale certification
- Manufacturing licenses
- quality data
- quality certification
- registration certification
- technical certification
- regulatory approval
- import/export license
Q. Steps to export medical equipment from India ?
To export medical equipment from India, obtain an Import-Export Code (IEC), research your target market, and ensure your products meet both Indian and international standards and regulations, including those of the Central Drugs Standard
Certification needed to export medical Devices
To export medical devices from India, you need
Free Sale Certificate (FSC) from the Central Drugs Standard Control Organization (CDSCO),
Medical Device Manufacturing License (from CDSCO or State Licensing Authority),
Import-Export Code (IEC) from the Directorate General of Foreign Trade (DGFT)
potentially ISO 13485 certification.
For More information about the certification course kindly
call us on 9322341947
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