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The Indian healthcare sector is expanding rapidly and is expected to reach $280 billion by 2025.
India is considered one of the leading markets in the world when it comes to medical devices and cosmetics. The Central Drug Standard Control Organization (CDSCO) regulates the medical devices and cosmetics that are manufactured, imported, and sold in India.
If any company wishes to manufacture, import, or sell medical devices in India, it must first register its device with CDSCO.
What is CDSCO?
CDSCO (Central Drugs Standard Control Organization) regulates the Indian medical device system and its licensing. A division of the Ministry of Health and Family Welfare, CDSCO is a government organization in India. Assuring the quality, safety, and efficacy of medications, cosmetics, and medical devices is central to the organization's mission of defending and enhancing public health.
There are many reasons why CDSCO registration is necessary, some of which are as follows:
• Clinical trial and new drug approval
• Licenses for imports
• Manufacturing medical devices requires a license
• Vaccines, certain medical devices, and blood banks are all subject to licensing
• Changes to the laws governing cosmetics and medications, as well as any related rules
• Participation in GMP certification programs run by the WHO
• Issuing personal licenses, export NOCs, and test licenses
• Testing of medicines by central laboratories
Who can apply for medical device registration under CDSCO ?
According to CDSCO guidelines, the following parties can register the medical devices under CDSCO-
· The manufacturer has a registered office in India;
· The authorized representative of the manufacturer;
· The manufacturer's subsidiary;
· Any other importer;
· Domestic manufacturer
Procedure to get your medical device registered with CDSCO
In 2020, the Ministry of Health and Family Welfare proposed an amendment to the Medical Device Registration Act that would require all importers and manufacturers of medical devices, in addition to the 37 categories previously notified, to register with the Central Licensing Authority via a designated portal made possible by the CDSCO.
Currently, in order to register a medical device under the CDSCO regime, the Importer or Manufacturer or their agent in India must submit an application for the CDSCO Medical Device Import License describing the facilities and devices manufactured by the Manufacturer and intended for import into India as per the following steps:
Step 1: Indian agents register themselves on the SUGAM online portal.
Step 2: Fees are to be paid online as prescribed by CDSCO for the manufacturing site and the proposed devices.
Step 3: Application to be submitted online in Form MD-14 along with the following information:
· Information About the Applicant
· Product Information
· Power of attorney
· Relevant certificates
· Device and Site Master File
Step 4: Once all of the aforementioned steps have been completed and all documents have been found satisfactory, the concerned Department will issue the Medical Import License in Form MD-15.
Documents Required for CDSCO Medical Device Registration
The following documents must be attached to the registration application on the CDSCO portal:
ID Proof Document
Address Proof Document
Undertaking issued by a Government Authority
Copy of BA/BE Site Registration, as approved by CDSCO, in case of BA /BE Approved sites Registration
Manufacturing license or wholesale license in case of import or manufacture of drugs/blood products registration/testing license registration
How we’ll help you get CDSCO Medical Device certification?
A Medical Device Import License in India under CDSCO is subject to a slew of requirements and documentation. Such requirements and documentation may be difficult to fulfill for new applicants. As a result, it is strongly advised that you contact Regulatory Solutions India, and we will walk you through each step of the licensing process. Regulatory Solutions India makes the process easier for our esteemed clients by handling all legalities on their behalf.
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