Because of the attention to long-term grooming solutions, India’s laser hair removal industry is growing at an unprecedented rate. You must obtain CDSCO approval to start laser hair removal business; this may be the best opportunity. For this business, it is not only important to buy equipment and rent a clinic. Legal compliance, especially with the CDSCO (Central Drugs Standard Control Organization), is very important to operate legally in India.
In this article, you will learn about the legal structure, registration, business license, and all relevant compliance needed to operate your laser hair removal business with full CDSCO compliance so that you can avoid tedious paperwork in the future.
CDSCO’s Involvement With Laser Hair Removal
CDSCO is responsible for overseeing the use of drugs, medical devices, and cosmetics in India. The rest of the Ministry of Health and Family Welfare sponsors the use of safe and effective marketed devices in India.
Why Do Laser Hair Removal Businesses Need CDSCO Compliance?
Laser hair removal devices are categorized as medical devices under the Medical Devices Rules 2017. If you do not use a registered or approved laser hair removal device, you could face legal actions, business closure, harm to your client, and/or trouble with the Medical Board. Completing CDSCO compliance before commencing a laser hair removal business is a requirement, not an option.
Steps To Get CDSCO Compliance To Start Laser Hair Removal Business
We prepared a legal guide for you to obtain CDSCO approval to start laser hair removal business with CDSCO-compliant equipment.
Register on the SUGAM Portal
All applications for CDSCO should be filed through the SUGAM portal (www.cdsco.gov.in). Create an account with your business name, GST number, and other necessary details and contact information.
Identify Equipment Classification
Identify and classify the laser machines. Check with the equipment supplier or a CDSCO regulatory consultant to see if your device is in Class C or D.
Compile Relevant Documents
Compile all the required documents for the application of COS-4A, and make sure all the documents provided contain correct information.
Apply for an Import or Manufacturing License
The origin of the equipment will be determined by Form MD-14/15 for the import of equipment. Form MD-3/5: for local manufacturers. If one is importing from a foreign company, an Authorized Indian Representative AIR has to be named.
Pay Government Fee
Each classification of device attracts a specific fee, which will be mandatory to pay during application intake. For device grade and quantity, fees start from ₹25,000 to ₹50,000 and above.
Inspection and Approval
After submission, CDSCO may wish to inspect your clinic and/or ask for additional documentation. Following this process, your business would be legally able to use, advertise, and distribute laser hair removal devices.
Other Legal and Operational Licenses Needed
Besides the CDSCO regulations, you also need the following to ensure CDSCO approval to start your laser hair removal business:
- Trade License: If you are running a business, you will most likely need a trade license from your local municipal corporation.
- GST Registration: You need a GST registration if your business has an annual turnover of ₹20 lakhs or more.
- Shops and Establishments Act License: This controls the working hours and employee conditions of the workplace.
- Fire Safety and Pollution NOC: Depending on the size of your clinic and its location, you may also need a fire NOC, as well as a pollution control board NOC.
- License for Bio-Medical Waste Management: If your business is disposing of razors and gloves clinically, you will need permission from the State Pollution Control Board to dispose of clinical waste.
Classification Of Laser Devices Under CDSCO
Medical devices are categorized under four classes of varying risk levels per CDSCO regulations:
- Class A – Low risk
- Class B – Low to Moderate Risk
- Class C – Moderate to High Risk
- Class D – High Risk
Hair removal lasers can be classified as Class C or D relative to their particular type and application. Due to the classification, you will need to complete a more extensive registration and approval process before being able to operate.
FAQs
Is Compliance with CDSCO Requirements Mandatory For Hair Removal Clinics Based In India?
Yes. The machines used for laser hair removal are classified as medical equipment. Using such devices without approval from the CDSCO is illegal.
Am I Allowed To Buy A Laser Machine From Overseas For My Clinic?
Yes, but if you’re not importing it as a licensed business, you’ll need to hire an Authorized Indian Representative to apply for a cosmetic import license through CDSCO.
How Much Does It Cost To Obtain CDSCO Approval?
The government charges somewhere between ₹25,000 to ₹50,000 for classification and the type of device. These are the bare minimum fees that you would have to pay. Additional charges from consultants will also be incurred.
Do I Need Medical Staff To Operate The Laser Machines?
Though not needed in all states, it is best practice to hire certified laser technicians or dermatologists to safeguard the client.
