All medical devices in India follow a regulatory framework under the Drugs and Cosmetic Act (1940). Under this the CDSCO has released a new medical device rule “Medical Device Rules (MDR), 2017” to maintain global standards in Manufacture, import and sale. This has been effected from JANUARY 2018 and the CDSCO has been releasing various updates and guidance regarding the rule MDR-2017.
In recent, the CDSCO has incorporated changes in the existing Medical device regulations by regulating more medical devices. This step is significant for patient’s safety and with this notification; all implantable and diagnostic medical devices will come under the regulatory framework. SO the Manufacture of such Medical Device which need to be imported to India will have to meet the CDSCO regulatory requirements starting from January 2020.
The CDSCO has issued a notice on 15 May 2019 for the newly notified medical device with its risk classifications. CDSCO has regulated eight Medical Devices which includes:
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Organ Preservative Solution – Class C
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CT scan Equipment – Class C
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MRI Equipment – Class C
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Defibrillators – Class C
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Dialysis Machine – Class C
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PET Equipment – Class C
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X-Ray Machine – Class C
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Bone Marrow cell separator – Class B
This means, the following devices will require registration and import License for selling their device in India under Medical device Rules, 2017. Both Indian and other foreign manufactures who are already importing their devices under this category must get Registered with CDSCO by APRIL 2020, will be legally allowed for marketing their products in INDIA.
Furthermore the CDSCO has included four other Medical devices which include Nebulizer- Class C, Blood pressure Monitoring Devices- Class B, Digital thermometer- Class B, Glucometer-Class C also to be registered with CDSCO by JANUARY 2020.
*Glucometer will be regulated under IVD Category
How Morulaa Healthtech can assist you in CDSCO Regulatory process?
Morulaa consistently works hard with an in-house regulatory team to conduct registration of medical device, IVDs and cosmetic in India by following CDSCO (Indian FDA)
With all expertise Knowledge Morulaa also assist in obtaining the Import license, test license to successfully import products into India with registration
Contact us for all types of Medical device, Cosmetics, IVD registration in India.