India imports nearly 80 percent of its medical devices and barriers to entry are lower compared to other industries.
Is drug license required for medical equipment?
Once notified, import, manufacture and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO). Manufacturers will also have to seek licences from the Drug Controller General of India (DCGI). Currently, only 23 medical devices are regulated under the Act.
How do I register my medical device in India?
Companies must register regulated medical devices with the DCGI before they can be introduced into the Indian market. For new medical devices, prior approval from the DCGI must be obtained before the device can apply for registration. Upon receipt of the application with fees, evaluation begins.
Does medical device require registration in India?
Medical devices and IVDs are regulated by the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO), part of the Ministry of Health and Family Welfare. Only a limited number of medical devices and IVDs require registration in India.
What medical devices are imported in India?
These include calorimeters, orthopaedic or fracture appliances, blood transfusion apparatus, surgical bone saws, cannulae, dialysis apparatus, endoscopes, baby incubators, stethoscopes, malaria diagnostic kits, pacemakers, and so on.
How can I export my medical equipment from India?
Free sale certificates valid for two years are issued to medical device manufacturers by state licensing authorities. To export medical devices, manufacturers need to register with the foreign country and obtain its regulatory approval. These authorities generally ask for a free sale certificate to allow imports.
How do you import medical equipment?
Ans: For the import of medical devices in India, Registration Certificate in Form 41 and Import License in Form 10 are required as per provisions of the Drugs & Cosmetic Act & Rules.
How do I get a medical device license?
Step by Step Process to Register Your Medical Device in India
- Step 1 – Determine If Your Product Requires Registration.
- Step 2 – Appoint an Authorized Indian Agent.
- Step 3 – Submit the Regulatory Dossier under Form 40.
- Step 4 – Obtain Registration Certificate in Form 41.
- Step 5 – Obtain Import License in Form 10.
Do you need license to sell oxygen concentrator in India?
New Delhi: The high court said that since medical devices like oxygen concentrators are also drugs according to the Act, therefore, a valid licence is required to manufacture, store or sell drugs and not having the same amounts to a violation which entails punishment of 10 years jail term.
Who is the regulator for medical devices in India?
Indian authorities overhauled the medical device regulatory process in 2017 with the publication of the Medical Device Rules. 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.
Can you sell a medical device without FDA approval?
In the U.S., FDA regulates the sale of medical device products. Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA. FDA does not tell providers what to do when running their business or what they can or cannot tell their patients.
How are medical devices classified in India?
Medical devices under the new Rules “Medical Devices Rules, 2017”are classified as per Global Harmonization Task Force (GHTF) based on associated risks, Class A (low risk) Class B (low moderate risk) Class C (moderate high risk)
What is a Class B medical device?
The AMDD classifies medical devices into four classes based on risk level. Class A products are low risk, Class B products are low-moderate risk, Class C products are moderate-high risk, and Class D products are high risk.
What is the full form of Cdsco?
The Central Drugs Standard Control Organisation (CDSCO)under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India.
What are the classes of medical devices?
There are 3 classes of medical devices:
- Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs.
- Class II devices are intermediate-risk devices.
- Class III devices are high-risk devices that are very important to health or sustaining life.