Medical Device Regulatory Compliance Services in India by MedDev Experts
MedDev Experts is a leading provider of medical device regulatory compliance services in India. We help medical device manufacturers, importers, and distributors obtain the medical device licenses, registrations, and approvals they need to market their medical devices in India.
Medical Device License & Registration Services
We offer a wide range of services, including:
- Medical Device Manufacturing License for Class A and Class B Devices (MD-5)
- Medical Device Import License (MD-15)
- Medical Device Loan License (MD-6 & MD-10)
- Medical Device Test License (MD-13)
- Medical Device Manufacturing License for Class C and Class D Devices (MD-9)
- Medical Device Wholesale License (MD-42)
- Free Sale Certificates
- Registration for Class A Devices
Medical Device License (MD-5) for Class A and Class B Devices in India
- The Medical Device Manufacturing License (MD-5) is required for the manufacturing of Class A and Class B medical devices in India.
- Class A and Class B medical devices are considered to be low-to-moderate risk devices.
- The MD-5 license is granted by the State Licensing Authority (SLA).
- The application to be submitted online through CDSCO SUGAM Portal.
- A qualified regulatory consultant can help you navigate the application process and ensure that your application is successful.
CDSCO License to Manufacture Class c and Class D Medical Devices in India (MD 9)
The Central Drugs Standard Control Organization (CDSCO) is the regulatory body in India responsible for the registration and licensing of medical devices. Class C and Class D medical devices are considered to be high-risk devices, and a license is required to manufacture them in India.
To obtain a CDSCO license to manufacture Class C and Class D medical devices, the manufacturer must submit an application in Form MD-7 through the Central Licensing Authority (CLA) of the Ministry of Health and Family Welfare in the Central Government. The application must be accompanied by a number of documents, including:
- A copy of the company’s registration certificate
- A copy of the company’s manufacturing premises
- A quality management system (QMS) certificate
- A list of the medical devices that will be manufactured
- A risk assessment report for each medical device
- A manufacturing process validation report for each medical device
- A sterilization process validation report for each medical device
- Device master file
CDSCO Import License for Medical Devices (MD 15)in India in India
- The MD 15 License is required for the import of medical devices into India.
- The import license is granted by the Central Drugs Standard Control Organization (CDSCO).
- The application to be submitted to the CDSCO through SUGAM PORTAL of CDSCO.
- MedDev Experts can help you navigate the application process and get Medical Device Import License.
An authorized agent having a license to manufacture for sale or distribution or a wholesale license for sale or distribution shall make an application for the grant of import license to the Central Licensing Authority (CDSCO) through an online SUGAM portal in Form MD 14 for obtaining a license to import Medical Devices including In-Vitro Devices of all Classes.
On receipt of an application, the CDSCO may cause an inspection of the overseas manufacturing site either by itself or by any other person or body to whom the power has been delegated for the purpose.
After examination of documents and on the basis of the inspection report, if an inspection has been carried out, the Central Licensing Authority may, on being satisfied, grant a license in Form MD 15 within a period of nine months from the date of application.
Where, a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competent authority of any of the countries namely, Australia, Canada, Japan, European Union Countries, or the United States of America, a license shall be granted to the applicant without carrying out a clinical investigation.
Where a medical device is imported from countries other than those referred to above, the license in the case of Class C and Class D medical devices may be granted after its safety and effectiveness have been established through clinical investigation in India. In the case of Class A or Class B medical devices may be granted after their safety and performance have been established through published safety and performance data or through clinical investigation in the country of origin and a free sale certificate from the country of origin is furnished.
Are You Planning to to obtain a CDSCO License to Manufacture Class C or Class D Medical Devices in India?
Contact MedDev Experts Today! We can help you navigate the application process and ensure that your application is successful.
Loan License to Manufacture Class C or Class D Medical Devices in India (MD 10)
- Apply through CDSCO’s online SUGAM Portal
- Required documents: Device master file, Form MD 8, Receipt of fee, Actual manufacturer consent, etc.
- Valid lifetime, unless it is revoked by the licensing authority and retained fee paid on an interval of 5 years.
The Central Licensing Authority (CLA) of the Central Drugs Standard Control Organization (CDSCO) grants loan licenses to manufacture Class C or Class D medical devices in India. You must submit an application form (Form MD 8) through the CDSCO’s online SUGAM Portal to apply for a loan license. The application form must be accompanied by the mandatory documents.
Documents Required for MD 10 Loan License by CDSCO
- Application Letter
- Application Form MD 8
- Receipt of fees
- Constitution of firm
- Documents of Site ownership/Tenancy agreement
- Plant Master File
- Details of Technical Persons
- Device Master File for each product
- Performance Evaluation Report (if applicable, for IVD)
- Consent letter from principal manufacturing unit.
- Wholesale licenses of the applicant loan licensee.
- Valid manufacturing licenses and of product permission of the principal manufacturer
Loan License to Manufacture Class A or Class B Medical Devices in India (MD 6)
- Apply through CDSCO’s online SUGAM Portal
- Required documents: Device master file, Form MD 4, Receipt of fee, Actual manufacturer consent, etc.
- Valid lifetime, unless it is revoked by the licensing authority and retained fee paid on an interval of 5 years.
The State Licensing Authority (SLA) grants loan licenses to manufacture Class A or Class B medical devices in India. You must submit an application form (Form MD 4) through the CDSCO’s online SUGAM Portal to apply for a loan license. The application form must be accompanied by the mandatory documents.
Documents Required for MD 6 Loan License
- Application Letter addressed to the State Licensing Authority
- Application Form to Manufacture Class A or Class B Medical Devices on a Loan Premises (MD 4)
- Receipt of fees
- Constitution of firm
- Rent Agreement / Sale Deed of the of the Principal Manufacturer
- Plant Master File / Site Master File
- Details of Technical Persons
- Device Master File for each distinctive device
- Performance Evaluation Report (if applicable, for IVD)
- Consent letter from principal manufacturing unit.
- Wholesale licenses of the applicant loan licensee.
Wholesale License for Medical Devices
Any person who intends to sell, stock, exhibit, or offer for sale or distribute medical devices, including in-vitro diagnostic medical devices, must obtain a wholesale license from the State Licensing Authority. The application for a wholesale license must be made in Form MD 41.
Documents needed for a medical device wholesale license in India
- Application form MD 41
- Constitution of firm
- Documents of site ownership/rent agreement
- Compliance with Good Distribution Practices (GDP)
- Educational Qualification and identity proof of the competent technical staff
- Compliance with storage requirements
- Building Layout
- Receipt of Fees
Test License for Medical Devices
A specific quantity of medical devices, including in-vitro diagnostic devices, can be manufactured for the purpose of clinical investigations, testing, evaluation, examination, demonstration, or training. To do this, you need to apply for a Test License from the Central Licensing Authority (CLA).
Documents needed for medical device test license in India:
- Application form MD 12
- A brief description of the devices
- A list of the equipment and instruments that will be used
- A list of the qualified personnel who will be involved
- A copy of the manufacturing license, if applicable
The CLA will review the application and, if it is approved, will issue a test license in Form MD 13. The test license is valid for three years, unless cancelled by the CLA.
Voluntary Registration of Class A Medical Devices
The Ministry of Health and Family Welfare, Government of India has notified the Medical Devices (6th Amendment) Rules, 2022, which exclude Class A (non-sterile and/or non-measuring) medical devices from licensing obligation. However, manufacturers and importers of these devices need to voluntarily register them on the CDSCO SUGAM Portal.
The registration number will be generated once the information is submitted on the portal. This is applicable to only non-sterile and non-measuring devices classified as Class A medical devices, including in-vitro diagnostic medical devices.
Documents needed for Voluntary Registration of Class A Medical Devices:
- Name and address of the manufacturing site
- Brief Description of the devices
- ISO 13485 Certificate
How to get a medical device license in India?
The Ministry of Health and Family Welfare, Government of India has notified the Medical Devices (6th Amendment) Rules, 2022, which exclude Class A (non-sterile and/or non-measuring) medical devices from licensing obligation. However, manufacturers and importers of these devices need to voluntarily register them on the CDSCO SUGAM Portal.
- Register on the CDSCO SUGAM portal.
- Select the appropriate application form (MD 3, MD 4, MD 7, MD 9, MD 14, MD 41, etc.).
- Upload the required documents and fees.
- Get audited by a notified body or CDSCO.
- Have your application scrutinized by the licensing authority.
- Receive your license.
