Hair removal products are widely utilized at salons, beauty clinics, and at home; however, it is often not clear to manufacturers and importers what the regulatory framework for hair removal products is. Companies should be clear whether to pursue compliance with cosmetic regulations or medical-device regulations before putting a product on the Indian market.
As per the Fourth Schedule of the Cosmetics Rules, 2020, physical epilation products are listed as a type of cosmetic product subject to import, so regulatory classification is a key point to consider for companies operating in the sphere of physical epilation products.
In order to understand what requirements must be satisfied in order to obtain CDSCO certification for physical epilation devices, one should first determine what specific product is being discussed and the purpose thereof. This article outlines relevant legislation, registration procedures, documents and other costs to bear, lead times, challenges, as well as the help offered by UMSPCS in operating in the Indian market.
Is the Use of Physical Epilation Products Within the Scope of CDSCO Regulations?
Physical epilation products are indeed included in India’s cosmetic import framework, as the Fourth Schedule of the Cosmetics Rules, 2020, sets out physical epilation products separately from chemical depilatories and other body hair removal products.
The Cosmetics Rules, 2020, state that this category is covered by Rule 12(6), a rule which designates the various categories of cosmetics that require import registration.
Companies must distinguish between cosmetic products that provide physical means of hair removal from electricity and mechanical devices called epilators. The type of regulatory process that should be undertaken for a product depends on how the device is constructed, how it is supposed to work, and its compliance with the respective product safety requirements. The fact that a certain electrical depilator removes hair does not automatically classify it as a cosmetic product.
For other products still being called cosmetics, it should be noted that CDSCO Certification for Cosmetic Products is more of a regulatory registration, rather than just one certificate valid for various devices used for hair removal.
What Counts as Physical Epilation Products?
Physical epilation products work by getting rid of unwanted body hair by means of physical action, not mainly by dissolving the hair with chemical ingredients.
The type of product this refers to will vary depending on how it is formulated, in what way it is presented and on its intended use, and may therefore include certain waxing preparations, wax strips and other products designed to remove hair physically.
They should be distinguished from:
- Chemical depilatories are products which employ chemical ingredients for the purpose of removing hair.
- Electrical epilators are powered devices which remove hair mechanically.
- Laser and intense pulsed light (IPL) devices are referred to as devices which utilize light technology to effectively diminish or eliminate hair.
- Post-epilation products are those which are intended to relax, moisturize, or cleanse one’s skin after the process of epilation is over.
These differences are crucial because even though there is the same commercial objective in both situations, i.e., hair removal, this does not mean that the same regulation applies in both cases.
What are the Laws that Govern CDSCO Certification in India?
The regulatory framework that applies is determined by the category of the product.
1. The Drugs and Cosmetics Act of 1940
Section 3(aaa) defines cosmetics in terms of products applied to the human body for cleansing, beautifying, enhancing beauty, or otherwise changing the looks, which is helpful in deciding whether a hair removal product is to be treated as a cosmetic.
2. Cosmetics Rules, 2020
The rules govern the registration of the import of cosmetics along with the manufacturing, labelling, and product quality requirements.
Cosmetics are not permitted to be imported into India unless they are registered with the Central Licensing Authority, and Rule 39 requires that the stipulated standards of quality and safety must be complied with.
3. Medical Devices Rules, 2017
If the epilation device used is electrical and is intended to be used in a medical application, the regulatory status of the product will have to be determined in terms of the Medical Devices Rules, 2017.
CDSCO has published guidance on medical devices providing information on regulatory policies applicable to medical devices.
Basic Requirements for Physical Epilation Product Registration
Before applying for CDSCO Certification for Physical Epilation Devices, businesses should assess the following requirements for products classified as cosmetics:
- Product classification
- Manufacturer details
- Product composition
- Product specifications
- Safety compliance
- Labelling
- Authorisation
- Regulatory documentation
The specific requirements will vary according to the product and its regulatory classification.
Documents Required for CDSCO Registration
When applying for imported cosmetic products, the applicant must put together a complete and consistent set of documentation.
- Identity of the organisation
- Rent document for the premise
- Master File of the plant
- Plan drawing of the building
- ISO 13485 certificate along with past audit report
- Technical manpower capable of manufacturing and testing devices
- Device Master File
- License for testing, if available
- Environment compliance
- Analysis report of three successive batches
The number of documents that may be needed will depend on the product, the country in which it is manufactured, and the regulatory assessment.
How to Obtain CDSCO Registration for Physical Epilation Products
The usual procedure for products that are regarded as cosmetics is as follows.
Step 1: Registration on the CDSCO SUGAM Portal
The applicant signs up on the CDSCO SUGAM Portal and supplies the necessary details regarding the business, the Indian agent, and the foreign manufacturer.
Key considerations:
- Applicant and Indian agent details
- Foreign manufacturer information
- Correct manufacturing site details
- Valid contact and registration information
Step 2: Preparation and Filing of Application
The product information in the application has been prepared in accordance with the Cosmetics Rules, 2020, since the product is subject to cosmetic regulations.
Key considerations:
- Product category and intended use
- Formulation and composition
- Manufacturing details
- Product variants and pack sizes
- Product specifications
Step 3: Submission of Required Documents
The applicant is providing the licensing authority with the relevant technical, manufacturing, and regulatory documents for assessment.
Key considerations:
- Ingredient composition and specifications
- Free Sale Certificate, where applicable
- Manufacturing licence and site details
- Product test reports, where required
- Proposed labels and manufacturer authorization
- Applicable declarations and undertakings
Step 4: Payment of Government Fees
The government fees required are paid depending on the relevant cosmetic category, the manufacturing sites, and the product variants.
Key considerations:
- Applicable category fee
- Manufacturing site fee
- Variant fee
- Verification and retention of payment receipts
Step 5: CDSCO Review and Grant of Registration
The Central Licensing Authority looks at the application and the supporting documents; if the requirements are satisfied, then the Import Registration Certificate in the form of COS-2 is issued for suitable cosmetic products.
Key considerations:
- Application and document assessment
- Verification of product and manufacturing details
- Resolution of regulatory queries
- Grant of registration upon approval
- Compliance with applicable import and labelling requirements
Government Fees for CDSCO Registration of Physical Epilation Cosmetics
The government fees for obtaining CDSCO certification for physical epilation devices are determined by the number of cosmetic categories, variants, and manufacturing sites listed in the application. According to the Third Schedule of the Cosmetics Rules, 2020, the fees applicable to imported cosmetics are as follows:
| Particular | Government Fee |
| Registration for each cosmetic category | US$1,000 |
| Each additional cosmetic category | US$1,000 |
| Each cosmetic variant | US$50 |
| Each manufacturing site | US$500 |
| New cosmetic permission | US$500 |
| Overseas manufacturing-site inspection | US$5,000 |
These are the official government fees, and the total amount will vary according to the application requirements and the relevant fee regulations, which should be checked before the application is submitted.
Timeline for CDSCO Certification of Physical Epilation Cosmetics
The time taken to obtain CDSCO Certification for physical epilation devices will depend on the type of application, the completeness of the documents, the classification of the product, and any extra information or testing that is required.
With regard to imported cosmetics: according to the Cosmetics Rules, 2020, the Central Licensing Authority must either approve or reject the application within six months of receiving it.
For domestically produced cosmetics, the State Licensing Authority must either grant the licence or give its observations within 45 days, on the condition that the application, the prescribed fee, and the necessary documents have been received and the relevant requirements are satisfied. Read more also: CDSCO Approval License
Common Challenges Businesses Face for Physical Epilation Device
Getting CDSCO registration for physical epilation products can be difficult if the product classification or the supporting documentation is unclear.
Common challenges include:
- Incorrect categorization
- Incomplete documentation
- Labelling discrepancies
- Safety concerns
- Regulatory queries
- Incorrect approval pathway
Looking at the classification and reviewing the documentation early on can help companies spot these problems before they file them.
What Makes UMSPCS the Choice CDSCO Certification for Physical Epilation Device?
At UMS Product Compliance (UMSPCS), we help manufacturers, importers, and brands to understand the regulatory requirements specific to a product in India.
With 6+ years of compliance experience and support across 600+ product compliance requirements, our assistance can include:
- The assessment of product classification and regulatory pathways.
- An analysis of the documentation gaps and the preparation of the application.
- An examination of the ingredient information, the product specifications, and the labels.
- Help with obtaining manufacturer authorization and the relevant documents.
- The submission of the CDSCO application and the coordination of any regulatory inquiries.
- Guidelines on registration and steps following registration.
Our approach towards documentation allows companies to be aware of the regulations associated with their goods even before starting the application process.
Conclusion
The Fourth Schedule of the Cosmetics Rules, 2020 mentions explicitly that physical epilation products are considered a type of cosmetics. The classification of electrical epilators and various devices for hair removal must also be determined with regard to their purpose and legal framework.
The first step for a company that wants to receive CDSCO Certification for physical epilation device is to classify its product properly and to find the right way to process its application.
UMSPCS will help the client to define its needs, prepare the documents in the right way, and submit the completed documentation for compliance.
Contact UMSPCS now to work out your product’s regulatory requirements before you enter the Indian market.
Read more also: How Do You Apply for BIS ISI Certification for Electrical Motors
FAQs
- Are physical epilation products regulated by the CDSCO?
Physical epilation products are included in the Fourth Schedule of the Cosmetics Rules, 2020, as a category of cosmetics subject to import. However, the classification of an electrical epilator has to be considered on its own.
- Is it necessary to have registration with the CDSCO for imported physical epilation products?
Registration is usually necessary before a product is imported into India if it falls within the scope of the cosmetic definition and meets the relevant cosmetic import requirements.
- What is the difference between physical epilation and chemical depilation?
Physical epilation involves the removal of hair by means of physical action, whereas chemical depilatories remove hair using chemical ingredients. The two categories are each listed in the cosmetic import framework.
- Do electrical epilators need CDSCO cosmetic registration?
Not necessarily; their regulatory status is based on the intended use of the product and on the relevant definitions. Assessment might also be required in relation to other safety requirements for electrical products.
- What form is used when registering a cosmetic import?
Form COS-1 is the one used when applying for import registration, and the Import Registration Certificate is issued on Form COS-2.
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