Does cosmetics import require license from Indian FDA?

For the import of cosmetics in India, the imported cosmetics products are required to be registered with Central Drugs Standard Control Organization (CDSCO).Cosmetic products and color additions do not need FDA approval before they go in the market. Although they should not be contaminated or misbranded. It means that they should be safe for the customers under labeled customary conditions to use, and they must be properly labeled. In the case of color additions and those ingredients which are banned or restricted by FDA regulations, a cosmetic firm can use any ingredient as long as it does not cause the product to be contaminated.

How is IEC different from medical device import license?

IEC Import Export Code is the first requirement you before you start an import/export code in India. An IEC is important for the import and export of goods. The IEC is issued by the Directorate General of Foreign Trade (DGFT) Ministries of Commerce and Government of India. For releasing any medical device the manufacturer has to attach to various rules set by the national regulatory bodies of India. The main regulatory body of India is Central Drugs Standard Control Organization (CDSCO). It is under Directorate General of Health Services, Ministry of health and family welfare. Under the drugs and cosmetics act CDSCO is responsible for the approval of drugs, conduct of clinical trials, laying down the standard of drugs, control over the quality of imported drugs, in the country. Further CDSCO along with state regulators is jointly responsible for granting licenses of certain specialized categories of critical drugs such as blood and blood products I.V. Fluids, Vaccine and sera.

Does medical device import require license from Indian FDA?

Ans-Yes. Under the provision of Drugs and Cosmetic act 1940, registration certificate and import license are required to import in India. For the introduction of medical device in the Indian market, the Manufacturers has to obey various norms set by national regulatory bodies of Saudi Arabia. The main regulatory body for medical device in India is Central Drugs Standard Control Organization (CDSCO). The Application for all classes of medical devices are submitted to Central Licensing Authority, where the (DCGI) Drug Controller General of India takes the responsibility for approval of Manufacturing, Registration, Import and Sale of Medical Devices in Saudi Arabia. When the Medical Device released to be imported it has some issued steps to be followed. The importers may also get the respective sale license from the State Licensing Authorities (SLA).

CDSCO Import License Consultancy Services for Medical Devices (Get Manufacturing License With Ease))

Indian CDSCO Import License - Overview

The Import License issued by the Indian Central Drugs Standard Control Organization (CDSCO) is a critical regulatory requirement for bringing medical devices into India from abroad. It ensures that all imported medical devices comply with established quality and safety standards. At Operon Strategist, we simplify the intricate process of securing the CDSCO Import License, helping you efficiently navigate the requirements to enter the Indian medical device market.

Who Should Apply for Indian CDSCO Import License for Medical Devices?

Applicable when you wish to import medical devices from Saudi Arabia to India. However medical devices need to be classified according to the CDSCO-notified devices list. CDSCO has a complete procedure for granting licenses for medical devices imported into India.

Application Process for Grant of Indian Import License in Saudi Arabia

An authorized agent holding a wholesale license for local distribution, along with a license to manufacture or distribute medical devices in India, must apply for an import license to the Central Licensing Authority via the designated online portal of the Ministry of Health and Family Welfare. The application should be submitted in Form MD-14 as per the regulations.

If the Central Licensing Authority suspects a compromise in the quality of the medical device, it may require the device to undergo testing, evaluation, or examination at a specified testing laboratory.

Following the review of documents and the inspection report, the Central Licensing Authority may either grant the license in Form MD-15 or reject the application, providing written reasons for the rejection. This decision must be made within nine months of the application date.

In case of rejection, the applicant has the right to appeal to the Central Government within 45 days. The Government, after conducting an inquiry, will issue an order on the matter within 90 days from the date of the appeal.

Medical Device Registration for Import:

Medical Devices entering India must comply with the Indian medical device regulation set forth by the CDSCO Registration. The CDSCO is responsible for approving and regulating New Drugs and Clinical Trials in the Country, laying down the standards for Drugs, controlling the quality of imported drugs, and coordinating the activity of State Drug Control Organizations.

Operon Strategist assists medical device distributors and medical device wholesalers in Saudi Arabia to procure CDSCO import license for medical devices. An Import license is issued for import of medical device from Saudi Arabia to India. Both the foreign company and Indian company jointly needs to submit the documentation for medical device and manufacturing unit.

Looking for Medical Device Regulatory Consultants in Saudi Arabia?

Pre-requisites:

Generic Name / Brand Name
Intended Use
Material of construction
Mode of application
Study of device details and Classification of medical devices on the basis of the notified product list of CDSCO
The class of device helps in determining the application form to be applied and also the application fees.

Indian Import License Application Phases for Saudi Arabia

The import of medical devices in India is regulated by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940. Industries or individuals holding a valid wholesale or manufacturing license issued by CDSCO are eligible to import medical devices into the country.

As per the latest regulations, foreign manufacturers must obtain a CDSCO registration certificate for their manufacturing premises and the specific medical devices they intend to import. Applications for these certificates can be submitted by authorized agents of Saudi Arabian firms operating in India. The required documentation for obtaining CDSCO registration certificates has been outlined in recent amendments.

The registration certificates are valid for three years from the date of issuance. For further details, feel free to contact us.

Phases in Indian Import License Registration:

Phase I – Application Registration
Phase II – Import License Application

Phase I – Applicant Registration:

In this phase after applying client can have an active account on CDSCO Online System for Medical Devices registration site.

Procedure for CDSCO Import License Application

Filling the Online Form
- Complete the online form and upload the required documents.
- Provide details of the manufacturing company, including:
  - Full corporate address
  - Contact details (email, phone number, fax number)
  - Name and ID proof of the authorized person
  - Company type (e.g., Ltd, Pvt. Ltd.)
  - Email ID for registration and an alternate email ID
  - Password for account creation
Preliminary Approval
- Upon submission, a preliminary approval is received from CDSCO.
- Hard copies of the documents must then be submitted to CDSCO for verification against the online submission.
Application Processing
- CDSCO reviews the application and supporting documents.
- Based on their evaluation, the application may be:
  - Approved: The import license is granted.
  - Rejected: An email will be sent specifying the reason for rejection.
Reapplication (if needed)
- In case of rejection, applicants must address the specified reasons and reapply by following the same process.

For a smooth application process, ensure all details and documents are accurate and complete.

Phase II – Import License Application:

This license is required to have permission to import medical device for commercial purpose.

Procedure for CDSCO Application via Online Portal

Filling the Online Form
- Provide detailed information about the medical device, including:
  - Generic name
  - Brand name
  - Class of device
  - Category of device
  - Packaging configuration
  - Shelf life
  - Sterile or non-sterile status
  - Intended use
  - Product description
  - Accessories and model details (if applicable)
Uploading Documents
- Upload all required documents to the portal after completing the form.
Payment of Fees
- Make the payment as per the CDSCO fee structure through the online portal.
- Upload the payment receipt on the portal.
Legal Form Generation
- A legal form is automatically generated based on the product information and the transaction details.
Application Review
- The submitted application moves to the “In-process” stage while under review.
- The application can either:
  - Be Approved: The test license is granted, and an approval email is sent.
  - Raise Queries: If there are any queries, revised documents or justifications must be uploaded online in response.
Approval of Test License
- If the query compliance is deemed satisfactory, the test license is approved, and confirmation is sent via email.

Ensure all provided information is accurate and complete to avoid delays in the approval process.

Operon Strategist's Expertise

Operon Strategist is the leading medical device regulatory consulting company. We provide regulatory guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers. We serve our clients by providing turnkey services, system implementation, training, licensing, regulatory approvals, and certifications. Contact us for further details.

Competencies

We reduce our client’s costs and efforts
We have Strong relations with regulated bodies
We also have a dedicated and experienced regulatory team
We represent on behalf of our clients for Audits of FDA, ISO, & CE.
Competent Technical staff.

Indian Import License Consultant For Medical Devices