#1 CDSCO Import License Consultant for Medical Devices
We streamline the CDSCO Import License process for medical device importers, so you can focus on delivering cutting-edge healthcare solutions.
Our dedicated team is committed to helping you navigate the complexities of regulatory compliance seamlessly. With our guidance, you can ensure your medical devices meet all CDSCO import requirements.
What is a CDSCO Import License?
A CDSCO Import License is a regulatory approval issued by India’s Central Drugs Standard Control Organization (CDSCO) to allow the importation of medical devices, pharmaceuticals, and cosmetic products into the country. It is required to ensure that imported healthcare products meet the necessary quality, safety, and efficacy standards established by the Indian government.
What is MD 15 Registration for Medical Device?
MD 15 Registration is a permission issued by the CDSCO to import medical devices into the country. It is required for all medical devices, regardless of their classification.
Latest Update by CDSCO for Medical Device Registration
After 1 October 2023, each and every medical device need to be registered with CDSCO prior to import into India. It means all imports need MD 15 Import License to import medical devices. MD 15 Import License is mandatory now.
Non-sterile and non-measuring Class A devices are exempted from the MD 15 license but the importer must register those non-sterile and non-measuring devices on CDSCO SUGAM portal before importing into India.
Contact MedDev Experts for your MD 15 Import License and Class A device registration. We provide a hassle-free registration and licensing process.
Are you looking for a CDSCO Import License Consultant?
MedDev Experts is the right choice for you. We have a proven track record of success in helping our clients obtain their CDSCO Import Licenses for Medical Devices quickly and efficiently.
To apply for MD 15 Registration, the importer must submit an application form and supporting documentation, including information about the medical device, the manufacturer, and the importer. The CDSCO will review the application and supporting documentation to determine whether to grant the registration.
Step 1: Register on the CDSCO SUGAM Portal
You need to register on the CDSCO SUGAM Portal with your valid email address. Aadhar Card, PAN, or any identity proof of the applicant is required along with the organization’s address proof like certification of incorporation or GST certificate.
The hard copies of the documents which were submitted during the user registration, should be sent to CDSCO office at New Delhi. After verification of these documents, CDSCO will approve your registration.
You need to register on the CDSCO SUGAM Portal with your valid email address. Aadhar Card, PAN, or any identity proof of the applicant is required along with the organization’s address proof like certification of incorporation or GST certificate.
Step 2: Apply for MD 15 License
You should fill out the MD 14 application form to get an MD 15 Import License. Any Indian authorized agent can apply for an MD 15 Import License.
Step 3: Submit essential documents
Upload the following essential documents:
Step 4: Pay the prescribed fee
Pay the fee as specified in the Medical Device Rules, 2017. The fee depends on the classification of the device and the total number of devices.
Step 5: Scrutiny of the documentation by CDSCO
After submission of your application, the CDSCO officials will review your documents in accordance with the Medical Device Rules, 2017.
Step 6: Audit of the overseas manufacturer, if needed
The licensing authority may initiate an audit at the overseas manufacturing site.
Step 7: CDSCO may ask for additional documents
If the CDSCO officials need any clarification or additional information related to the device, they may raise a query. The queries should be addressed by the applicant with proper justification and documentation.
Step 8: Issue of License
If the licensing authority find everting is in order, MD 15 Import License will be issued to the applicant. Now the applicant can import the medical devices into India.
Once MD 15 Registration is granted, the importer can begin importing the medical device into India. However, the importer must continue to comply with all applicable CDSCO regulations, such as maintaining records of all imported medical devices.
Who is CDSCO Import license Consultant for Medical Devices?
MedDev Experts is the #1 CDSCO Import License Consultant in India. MedDev Experts helps medical device importers obtain the necessary import licenses from the CDSCO. We provide guidance and assistance throughout the application process, from reviewing the required documentation to submitting the application and following up with the CDSCO.
MedDev Experts helps importers who are new to the Indian market or who are unfamiliar with the CDSCO’s complex import regulations. By working with us, importers can increase their chances of having their import license applications approved quickly and efficiently.
Why Choose MedDev Experts as Your CDSCO Import License Consultant?
We understand that the CDSCO import licensing process can be complex and time-consuming, which is why we offer our clients a comprehensive range of services to help them navigate the process smoothly and efficiently. Our services include:
- Free consultation: We offer a free consultation to all of our potential clients so that we can understand their specific needs and requirements and develop a customized plan to help them achieve their goals.
- Documentation assistance: We can help you with all aspects of the documentation process, from ensuring that you have all of the required documents to reviewing your documentation for accuracy and completeness.
- Submission assistance: We can help you submit your documentation to the CDSCO and follow up on the application process to ensure that your application is processed in a timely manner.
- One-Stop-Solution: We offer a comprehensive range of services for all your medical device licensing requirement. We help you navigate the process smoothly and efficiently.
- Cost Effective: We offer competitive pricing and flexible payment options.
CDSCO Medical Device Registration Update: MD 15 Import License Now Mandatory
After October 1, 2023, all medical devices imported into India must be registered with CDSCO and have an MD 15 Import License. Non-sterile and non-measuring Class A devices are exempt from the license, but must still be registered with CDSCO.
If you are searching for a CDSCO Consultant for your Medical Device Import License, contact us today. We would be happy to help you through the process. Our dedicated team is here to answer your questions, provide guidance, and support you throughout the registration process.
Phone
+91-78079-14459