India’s laser hair removal industry is booming at an unprecedented rate. Growth of the grooming industry, rising awareness of aesthetic treatments, and technological advancements are all driving the growth. CDSCO regulates the laser hair removal and skin laser machines for improved consumer safety. Hair removal lasers are considered medical devices and are regulated accordingly. Currently, India’s laser hair removal industry is significantly import dependant. To import hair removal lasers, you need to secure the CDSCO MD 15 import license. We have prepared this guide to help you easily secure the CDSCO import license for hair removal lasers.
India’s laser hair removal industry
The laser hair removal industry in India is experiencing rapid growth. It is driven by rising demand for advanced aesthetic procedures, increasing disposable incomes, and strong influence of social media on beauty standards. The market includes both professional clinic devices and a growing segment of at-home laser devices. India’s laser hair removal industry is projected to grow at a compound annual growth rate (CAGR) of 16.93% during the period 2025 to 2033. Notably, clinic-based laser hair removal has emerged as a large market segment. However, at-home laser devices are expected to remain an attractive and fast-growing segment of the market.
5 Key market drivers
- Rising aesthetic awareness: Increased exposure to global beauty trends through social media is driving the demand for laser treatments.
- Technological advancements: Innovations in laser technology have made treatments more effective, safer, and less painful. This includes advancements in cooling systems and devices with multiple wavelengths to suit a wider range of skin and hair types.
- Demand for long-lasting solutions: Consumers are increasingly seeking permanent or long-lasting hair removal. Laser treatment can provide this more effectively than traditional methods.
- Home-use devices: The increasing popularity and accessibility of at-home laser devices are also a significant market driver.
- Lifestyle changes: Urban lifestyle changes prioritize personal grooming and self-care. This is contributing to the demand for aesthetic solutions, such as laser hair removal.
Therefore, the India’s booming laser hair removal industry presents a lucrative opportunity for entrepreneurs. Are you planning to venture into the laser hair removal and skin laser industry? Planning to import hair removal lasers? You will require the CDSCO import license for hair removal lasers. Moreover, you need to comply with the CDSCO regulations for importing medical devices to legally market your product in India. We have prepared this detailed guide just for you.
CDSCO import license for hair removal lasers
Hair removal lasers and skin lasers are classified as Class C medical devices. Hence, to import hair removal lasers, you will have to secure the CDSCO import license.
- Form MD 14: To import hair removal lasers into India, an application has to be filed under Form MD 14.
- MD 15 license: The license for importing hair removal lasers for sale and distribution in India is granted under the CDSCO MD 15.
Rules for foreign medical devices manufacturers
Foreign medical device manufacturers, not having a local presence in India, planning to sell their devices in India will have to appoint an authorized agent. The authorized agent must have a valid wholesale license (MD 42). Thus, the Indian authorized agent will file the CDSCO medical device import license application on behalf of the foreign manufacturer. Furthermore, the authorized agent will act as a liaison between the foreign manufacturer and CDSCO.
Who can apply for the CDSCO MD 15 license?
The following entities can apply for CDSCO import license for hair removal lasers and skin lasers.
- Any wholesaler or importer who wants to import hair removal lasers for sale and distribution in India
- Any foreign medical device manufacturer who wants to supply medical devices in India. However, the foreign manufacturer will have to file the application via the authorised agent.
- An Indian authorized agent who has a valid wholesale license for the sale or distribution of medical devices.
Documents for obtaining CDSCO import license for hair removal lasers
Supporting documents have to be prepared for the CDSCO import license application. These documents have a vital role in demonstrating regulatory compliance.
- Self-attested copy of valid manufacturing license demonstrating the device is manufactured in accordance with the regulatory requirements of the country of origin.
- Plant master file
- Device master file
- Notarized copy of overseas manufacturing site or plant registration in the country of origin issued by the competent authority
- Notarized copy of ISO 13485 certificate of the actual medical device manufacturer
- Duly apostilled/notarized copy of Free Sale Certificate from National Regulatory Authority of country of origin
- Full Quality Assurance Certificate/CE type examination certificate/CE product quality assurance certificate
- Notarized Declaration of Conformity stating the device complies with applicable regulatory requirements and standards.
- A copy of the latest inspection or audit report carried out by Notified bodies or the National Regulatory Authority within last 3 years
- Power of attorney, in case an authorized agent has to be appointed
- Constitution details of Indian authorized agent for foreign medical device manufacturers.
- Notarized CE design certificate
For a detailed list of necessary supporting documents, feel free to get in touch with us. Furthermore, we provide document preparation support. Our team will not only prepare the documents but also compile them per CDSCO regulatory guidelines. Accurate and correct documentation per guidelines is critical to easily get the CDSCO import license for hair removal lasers.
CDSCO import license application fees
A fee of$3,000 per site along with $1,5000 per product will be required to secure the import license for hair removal lasers and skin lasers.
How to get the import license for hair removal lasers?
We have prepared a step-by-step guide to help you easily secure the CDSCO import license for hair removal lasers.
- Step 1: Register on the official CDSCO online portal, SUGAM.
- Step 2: Prepare and compile all necessary supporting documents per CDSCO guidelines.
- Step 3: Fill in the MD 14 application form with all the required details. Ensure accuracy and completeness.
- Step 4: Upload the duly filed in application form along with the necessary documents on the online portal. Next, pay the necessary fees for the import license application. Once you have successfully completed all the steps and submitted your application, you will receive an application number.
- Step 5: The CDSCO will review the MD-15 application for compliance with regulatory guidelines and verify the documents. They will try to check for any areas of non-conformities. It is important to promptly and appropriately respond to all queries. Response should be provided in a timely manner along with additional documents (if required) to support the response
- Step 6: The CDSCO may inspect the importing firm’s medical device facility to verify whether it meets the quality and regulatory standards.
- Step 7: CDSCO will evaluate all the information provided and check the response to the queries. If satisfied, they will approve the application. The CDSCO medical device import license will be granted under MD 15. This license will permit you to import hair removal lasers for sale and distribution in India.
Validity of the CDSCO import license
The CDSCO import license for hair removal lasers remains valid indefinitely. However, a license retention fee has to be paid every 5 years to retain its validity.
Will a change in the authorized agent require a fresh import license application?
Yes, a change in the Indian authorized agent will require a fresh import license application.
Can the CDSCO import license be transferred to another entity or individual?
No, you cannot transfer your CDSCO import license to another entity or individual.
Want to easily secure the CDSCO import license for hair removal lasers and skin lasers. To get in touch, email at [email protected] or call/Whatsapp on 9996859227.
