- CDSCO is the Authority regulating the grant of permission to manufacture / import license for new medical devices in India.
- The manufacturing/import license is the mandatory requirement for selling and distributing new medical devices that do not have a predicate medical device in India.
- Form MD 26 is the application form to be submitted to Central Licensing Authority (CLA)for approval, and CDSCO will issue the permission license in Form MD 27.
- The timeline for obtaining new medical devices is between 2 to 3 months.
- The Government charges a prerequisite fee of 50000 INR for obtaining this license.
What is Form MD 26 and MD 27?
Forms MD 26 and MD 27 are the primary documents for starting a business selling and distributing new medical devices. In addition, MD 27 provides permission for the specifications and standards of imported medical devices in India.
- Form MD 26 is the application form submitted to CLA to get permission for manufacturing/importing a new medical device that does not have predicate devices in India.
- Form MD 27 is the permission approved by the CDSCO to manufacture/ import a new medical device.
Who Can Apply For Manufacturing / Import License For New Medical Device?
To obtain a manufacturing /import license for a new medical device that does not have a predicate medical device, a manufacturer or importer must hire an Authorised agent who will act on their behalf for the application process.
An authorized agent must hold a valid wholesale or manufacturing license for medical device sale and distribution. The applicant must make an application in Form MD 26 to the CLA via the online portal of the Central Government of India, and permission will be received in Form MD 27.
How To Apply For Manufacturing / Import License For New Medical Device?
The application process for issuing manufacturing / import licenses for a new medical is ruled under the MDR, 2017 provisions.
- The manufacturer/importer must evaluate and classify medical devices (Class A, B, C & D) as per MDR, 2017.
- The applicant must prepare the documents as per the Form MD 26 checklist.
- The applicant must hire an authorized agent to file the online application in case of importing a product.
- Authorized representatives must carry out the regulatory processes before the final submission.
- These agents must generate the online application, confirm and approve the draft application, and follow up with regulatory authorities and SEC meetings for Clinical Investigation Waiver.
- If all the documents are in line and the Clinical Investigation Waiver is received, the manufacturing /import license for a new medical device is approved in Form MD 27.
- The timeline to receive this license is around two to three months.
Essential Documents For Manufacture / Import License For New Medical Device
The following list of documents is essential while applying for a manufacturing /import license:
- Wholesale Licence
- Free Sale Certificate from GHTF
- A notarized copy of a foreign manufacturing plant or registration of establishment
- Bio-compatibility tests data
- Data for Design Analysis
- Pharmacovigilance data
- Risk management data
- Safety and performance data
- Animal performance data
- A copy of a letter with the number and date showing approval status in countries like the USA, UK, Australia, Japan, Canada, and EU.
- All details of the country where these devices have been sold for the past two years.
Fee To Manufacture Or Import New Medical Device
The fee structure for the manufacturing /import license grant for new medical devices that do not have their predicate device is 50000 INR.
Validity Of Import / Manufacture New Medical Device License
As per the MDR 2017, the validity of the manufacturing /import license for new medical devices is not specified for now.
Timeline Of Import / Manufacture New Medical Device License
The procedure for procurement of the manufacturing /import license for new medical devices is a Government process. CDSCO issues Form 27 within two to three months.
Benefits Of Import / Manufacture New Medical Device License
- Ensures patients safety
- Improves brand identity
- Meets high demand for medical devices
- Creates opportunities for overseas manufacturers.
Conclusion
Central Drugs Standard Control Organization is the governing authority associated with approving manufacturing/import licenses for new medical devices in India. So, any company that wants to import/manufacture a notified medical device that does not have a predicate medical device in India, must hold the manufacturing/import license authorized by CDSCO. This license is obtained in Form MD 27, provisioned under Medical Devices Rules (MDR), 2017.
Reference
Manufacture/Import New Medical Devices License (Form MD 26 27)
Available from – https://cliniexperts.com/india-regulatory-services/medical-device/investigational-new-device-new-device-first-time-in-india/manufacture-import-new-medical-device-license-india-cdsco-form-md-26-md-27/