When Is CDSCO Registration Required in India? Products, Rules & Application Process

A product may be entirely safe, well designed, and commercially successful, yet if it comes within the scope of India’s regulated healthcare or cosmetic sectors, there can be serious compliance problems if it is sold or imported without the necessary CDSCO approval.

It is in this area that companies tend to become confused. Does every product relating to healthcare have to obtain CDSCO registration in India? Is a cosmetic registered in the same manner as a medical device? What occurs if the product is imported? And which documents or approvals are in fact needed before the product can be placed on the Indian market?

It all depends on the product category, its intended use, its risk classification, the place where it is manufactured, and whether the product is manufactured or imported.

In this blog, we clarify when it is necessary to obtain CDSCO registration in India, which products are subject to CDSCO regulation, the relevant legal framework, the documents required, the procedure, the validity period, the timeframes, the common difficulties, and how businesses can properly deal with the registration process.

What Does CDSCO Registration in India Entail?

The CDSCO, known as the Central Drugs Standard Control Organization, is the regulatory agency for drugs, cosmetics, medical devices, and other products under the regulatory ambit of the Ministry of Health and Family Welfare in India. 

The CDSCO performs the functions of a regulatory authority through the SUGAM Portal, which provides various services like cosmetic product registration and import licences for all medical devices.

“CDSCO Registration” is not a single certificate that applies to all products; the process for obtaining approval depends on the regulatory category.

For example:

Cosmetics that are imported might be required to obtain cosmetic registration under the Cosmetics Rules, 2020.

Generally, imported medical devices will need an import licence pursuant to the Medical Devices Rules, 2017. Medical devices made in India must obtain the relevant manufacturing licence route.

There are particular registration requirements applicable to some low-risk Class A medical devices. The very first step is to identify the product and carry out its regulatory classification.

What Products Need to Have CDSCO Registration or Approval?

The requirement can broadly arise for products falling under regulated categories such as:

1. CDSCO for Cosmetics

Any businesses that are importing cosmetics with a view to selling them in India must comply with the Cosmetics Rules, 2020 and meet the relevant registration requirements.

Examples may include:

• Skin-care products
• Hair-care products
• Make-up products
• Shampoos and conditioners
• Facial products
• Bath and body products
• Certain oral-care products
• Perfumes and similar cosmetic preparations

The framework established by CDSCO covers the import of cosmetics into India. CDSCO registration for cosmetics is therefore especially important for foreign manufacturers, Indian importers, brand owners, and authorised agents.

2. CDSCO for Medical Devices

Medical devices are subject to regulation under the Drugs & Cosmetics Act, 1940 and the Medical Devices Rules, 2017. The CDSCO says that medical devices are divided into four categories based on risk:

Examples can include:

• Surgical instruments
• Diagnostic equipment
• Orthopaedic devices
• Hospital equipment
• Respiratory devices
• Dental devices
• Ophthalmic devices
• Implants
• Certain software and accessories
• In-vitro diagnostic medical devices

When applying for an import licence for medical devices, Form MD-14 is used, and the licence itself is issued on Form MD-15.

Hence, any business looking to obtain CDSCO Registration for medical devices should first determine the classification and regulatory route that applies to the device.

Legal Framework Governing CDSCO Registration in India

The principal regulatory frameworks include:

Drugs & Cosmetics Act, 1940

It is the basic law relating to drugs and cosmetics in India and establishes the general legal framework within which the pertinent rules function.

Cosmetics Rules, 2020

The Cosmetics Rules of 2020 cover various areas such as the import and regulation of cosmetics, and CDSCO makes the rules and relevant guidance available on its official website.

Medical Devices Rules, 2017

Medical devices are subject to regulation under the Medical Devices Rules of 2017, together with any subsequent amendments and notifications. The CDSCO keeps on issuing amendments, classifications, and regulatory updates within this system.

SUGAM Portal

The SUGAM platform offered by CDSCO enables a number of online regulatory procedures, such as the registration of cosmetics and the licensing of imports of medical devices.

CDSCO Registration Process: From Product Identification to Approval

While the precise method may differ according to the product, companies are generally able to adhere to this sequence.

Step 1: Product Classification

In the first step, identify which regulatory category the product falls under according to relevant CDSCO definitions, including that of drugs, medical devices, cosmetics, or in vitro diagnostic products, as each has its own approval process.

Step 2: Application Preparation & Submission

Prepare the application and any supporting documents according to the product category and the relevant regulatory requirements; also pay the prescribed CDSCO registration or application fees and submit the application online via the appropriate CDSCO portal or SUGAM Portal.

Step 3: Technical and Documentation Evaluation

The CDSCO will review the application along with the supporting documentation, including technical, clinical, quality, manufacturing, safety, or product-related information, where the applicant will respond or submit further documents if any shortcomings or concerns are highlighted.

Step 4: Inspection, if Necessary 

The regulatory authority concerned, whether it be the CDSCO or otherwise, might carry out an inspection of the manufacturing facility or may ask for further evaluation, testing, or verification of compliance in order to determine if the relevant regulatory and quality requirements are being met.

Step 5: Grant of Registration, Licence or Approval

When the application has successfully gone through the relevant review, evaluation, and compliance requirements, the competent authority can issue the appropriate CDSCO registration, certificate, licence, or approval, according to the product and the applicable regulations.

Documents Required for CDSCO Registration in India

The exact documentation depends on the product, but commonly required documents may include:

• Application (in CDSCO format)
• Drug Master File or Device Master File (DMF)
• Certificate of Free Sale
• GMP or ISO 13485 Certifications
• Clinical assessment or performance information
• IFU and product labelling
• Attorney’s Power (for importers)
• Manufacturing license
• Receipt for charge payment for CDSCO enrolment

How Long Does it Take to Get CDSCO Registration?

There is no single timeline that applies to all CDSCO registrations in India. The actual time can depend on:

• Product category
• Risk classification
• Imported or domestic status
• Number of products/variants
• Completeness of documentation
• Testing requirements
• Regulatory queries
• Foreign manufacturer documentation
• Application corrections
• CDSCO review

In the case of cosmetics, the regulations specify certain time periods for particular decisions, even though the overall commercial schedule will still be determined by the readiness of the documents and by the questions that arise. 

For example, the Cosmetics Rules allow 6 months for a decision on an application for an Import Registration Number in the case of cosmetics that are already covered by a registration under Rule 17.

Benefits of Obtaining CDSCO Registration in India

Obtaining the applicable regulatory approval can help businesses:

• Legally place regulated products on the Indian market
• Complete import-related regulatory requirements
• Establish regulatory compliance
• Support smoother product launches
• Build confidence among distributors and business partners
• Maintain proper product documentation
• Reduce the risk of regulatory objections
• Establish a structured compliance process for future products

Compliance with regard to regulated products should, where the relevant law requires prior approval, be dealt with before the product is imported, manufactured, distributed, or commercially launched.

How UMSPCS Can Help with CDSCO Registration

At UMSPCS assist businesses in meeting the regulatory requirements that apply to cosmetics, medical devices, and other regulated products in India. 

Due to our experience in the industry spanning more than 6 years and our knowledge of 600+ product compliance requirements in a number of different sectors, we help companies to identify the correct regulatory pathway and to prepare their applications accurately. 

Our support can include:

• Product regulatory assessment
• CDSCO applicability analysis
• Medical-device classification support
• CDSCO Registration for Cosmetics
• CDSCO Registration for Medical Devices
• Documentation and application preparation
• SUGAM Portal application support
• AIR documentation coordination
• document review
• Regulatory query assistance
• Application tracking and compliance support

The aim is to assist businesses in determining the right regulatory pathway before they spend time and resources on a wrong application.

Conclusion

The first step in legally and efficiently launching a regulated product in India is to work out when CDSCO registration is required; the appropriate approval will depend on the product category, its intended use, its risk classification, the site of manufacturing, and whether the product is being imported or produced domestically.

A product-specific assessment can help you to decide on the right compliance route, whatever your requirement may be regarding CDSCO Registration for Cosmetics, CDSCO Registration for Medical Devices, import licensing, or assistance with regulatory documentation.

UMSPCS will assist you in evaluating the relevant requirements, putting together the necessary documentation, and going through the CDSCO application process.

Connect with UMSPCS and make the first move towards compliant product registration in India.

Read more also: IS 8043 Compliance: BIS ISI for Hydrophobic Portland Cement

FAQs

1. In India, when is it necessary to obtain CDSCO registration?

If a product comes within a regulated area such as cosmetics or medical devices, it may be necessary to obtain registration or approval from CDSCO as required by the relevant rules.

2. Is it necessary to have registration with the CDSCO for cosmetics that are imported?

Cosmetics that are imported for sale in India must comply with the registration and compliance requirements set out in the Cosmetics Rules, 2020.

3. What does CDSCO registration of medical devices entail?

The regulatory pathway that applies to medical devices is determined by the device’s classification and function, and imported devices usually need the relevant import licence provided for under the Medical Devices Rules, 2017.

4. What is the system of classification of medical devices in India?

The classification of medical devices into classes A, B, C, and D is done by reference to the Medical Devices Rules, 2017 according to the level of risk they pose.

5. Is it possible for foreign manufacturers to get approval from the CDSCO?

Yes, foreign manufacturers are able to make use of the relevant Indian regulatory routes by means of the prescribed Indian applicant or authorised representative arrangements and documentation.

6. What portal do you use for submitting CDSCO applications?

The SUGAM Portal operated by CDSCO is used for a number of regulatory services, such as the registration of cosmetics and the licensing of imports of medical devices.