CDSCO Import License

Overview of CDSCO Registration

                                        

Objectives of CDSCO Registration

• Blood Product Registration for registering blood products
• No Objection Certificate for Export Related to Any Specific Zone
• To facilitate Blood Bank Registration and Cosmetics Registration
• Obtaining the Test Licence and the Trader Dual Use No Objection Certificate
• Authorized sites with the abbreviation BA, which stands for bioavailability or bioequivalence
• Drug production as well as importation; registration of the ethics committee; formulation by the research and development organization.

Who Needs It?

Not every business dealing in health products needs to walk this path, but most importers eventually do:

• Foreign manufacturers who want their drugs, devices, or cosmetics sold in India

• Indian companies importing finished medical devices, drugs, or cosmetic products for resale

• Authorised Indian Agents appointed by an overseas manufacturer to handle the application on their behalf

• Distributors bringing in IVDs (in-vitro diagnostics) or blood products from outside India

• Companies importing raw materials or components where final assembly happens overseas, not in IndiaIf assembly or packaging of the finished product happens on Indian soil using imported components, the requirement shifts that's a manufacturing license, not an import one. Getting this distinction wrong at the classification stage is one of the more common (and costly) mistakes applicants make.

Types of CDSCO license

CDSCO doesn't run a single import approval. What you apply for depends entirely on what you're bringing in:

• Medical device import license (MD-15): Covers notified medical devices and IVDs across all risk classes A, B, C, and D.

• Drug import registration certificate: Required for finished pharmaceutical formulations entering India for sale.

• Cosmetics import license: Governed by the Cosmetics Rules, 2020, filed on Form COS-1 through the SUGAM portal.

• Test license (import): For small quantities brought in strictly for clinical trials, evaluation, or demonstration not commercial sale.

• Class A NSNM import registration: A lighter, self-declared route for Class A Non-Sterile, Non-Measuring devices which skips the full MD-14/MD-15 licensing cycle altogether.

Who Can Apply for CDSCO License?

The applicants who may submit an online CDSCO Registration application in India are as follows:

• Indian Agent 
• Foreign Manufacturer
• Foreign manufacturing having a registered office in India

Licensing Authorities Under CDSCO

In order to give CDSCO registration online, there are two licensing authorities, which consist of:

1. SLA or State Licencing Authority:

   The CDSCO Medical Device Manufacturer Registration that falls under Classes A, and B & Wholesale License for Medical Equipment and IVD (in-vitro diagnostics) be issued by the SLA.
    

2. CLA or Central Licensing Authority:

   For intravenous (IV and medical equipment that falls under Classes C and D, the Central Licencing Authorities (CLA) are in charge of issuing the CDSCO production or wholesale license. In addition, it is in charge of issuing cosmetic import permits for India. 

Different divisions of CDSCO

1. Cosmetics Import Division: 

   Cosmetics are defined by the Drugs & Cosmetics Act as any substance that is purposefully patted, sprayed, utilized, or used on the human body or any part of it for decorating, cleaning, shining, or changing the appearance. This involves any substance intended to be applied as an ingredient of cosmetics. According to the Act and its corresponding rules, the manufacturing of cosmetics is subject to examination and licensing by the State Licencing Authorities designated by the relevant State Governments, whereas the import of cosmetics is regulated by a system of registration by the authority designated by the Central Government.

2. DCC-DTAB: 

   It makes recommendations regarding how the Drugs and Cosmetics Act and Rules should be amended to address issues highlighted during the administration of the Act and its implementing rules. The conference is also organized by DCC-DTAB to ensure that the rules are checked effectively. DCC-DTAB also plans the meeting to ensure that the rules are followed to the letter.

3. BA/BE: 

   Bioavailability, also known as bioavailability, is the quantity of medicine that reaches the intrinsic circulation and is thereafter capable of having an active effect on the organism. When two medications perform identically in all respects by giving in equal amounts, they are referred to be (bioequivalence) pharmaceuticals.

4. Drug Import and Registration: 

   The import of medicines into India is governed by Chapter III of the Act and Part IV of the Rules. Drug Registration and import license requests are handled in accordance with the Drugs & Cosmetics Rules.

5. New Drugs:

   Before a drug product may be approved for manufacturing, import, or manufacture within the nation, it must demonstrate its safety and effectiveness for use in humans. As defined by Rule 122-E of the Drugs & Cosmetics Rules, new drugs are those that have not been used to a significant degree in India under the conditions suggested in their labelling and have not been recognized as secure & operational by the authority mentioned under Rule 21 of the relevant affirmation. This includes phytopharmaceutical drugs as well as new drugs that contain bulk drug substances.

6. Medical Devices and Diagnostics:

   The Act & Rules of Drugs & Cosmetics issued thereunder, which were passed in 1945, now exclusively govern notified Medical Devices in India as drugs. It includes Stapes, sutures, bandages, ligatures, blood, and its component collecting bags with/without anticoagulants are materials used during artificial insemination identification and incision dressing. Substances include insecticides, intrauterine devices, antiseptics, and prophylactic methods.

7. Biological:

   Medical items classified as biological are mostly derived from various natural sources, and the majority of biologicals are on the market today. Similarly, to some drugs, some biological substances are intended to treat illnesses and other medical issues. The prevention or diagnosis of illnesses also uses other biological products or objects.

8. Vaccines: 

   These include human organs, cells, and tissues used in transplants, gene, and cellular therapies, tests to identify blood donors, and plant extracts that are used to treat and diagnose allergic reactions.

Documents for CDSCO Registration

• Plant Master File
• Site Master File
• Process flow chart
• Label of the product, if required
• Details of the Authorized Agent's
• Details of the Manufacturer Entity
• Power of Attorney duly signed & notarized
• Details of the products to be manufactured
• Copy of ISO Certificate for quality manuals
• List of ingredients along with the percentage
• Free sale certificate duly notarized, apostille
• Wholesale Licence or Manufacturing Licence
• Undertaking & Declarations for No-Animal Testing
• Details of the components for manufacturing products
• Testing Reports and testing procedures used for product 
• No Heavy metal of Hexachlorophene content in the product
• Cover Letter stating the purpose of applying for the registration

Registration Process of CDSCO

The process of acquiring CDSCO registration is a completely online process that can be completed at the convenience of your home. Provided below is the  step-by-step process to obtain registration under the CDSCO portal:

Step 1: Signup and get Login credentials: 

Go to the CDSCO SUGAM PORTAL and select the Signup option. Then, the applicant needs to fill out every field necessary for the application, such as name, date of birth, address, nationality, email address, and password for accessing the account, and click submit. Following submission, the candidate will get login details at the email address they provided.

Step 2: Fill & Submit Form: 

After accessing the portal, the applicant shall go to his account and select the required form depending on the desired category of registration and the location for registration. Then fill out the information about the applicant organization and its authorized representatives along with the required pdf docs for registration. Revise the form once before submission to prevent errors, and submit the form.

Step 3: Verification & Forwarding of the Application: 

An email with an authentication link will be forwarded to the email address provided by the applicant.  After verification, the application shall be forwarded to the approval authority.

Step 4: Grant of CDSCO Registration: 

Post the verification, the applicant will further receive a confirmation for approval/rejection of the application through an email address after which the registration certificate could be downloaded through the portal.

Benefits of CDSCO Registration

There are numerous ways in which the CDSCO Registration has proven beneficial, a few of which are listed below:

1. Enhances Brand Reputation:

   CDSCO Registration in India enhances the brand's reputation and serves as a crucial means to attract customers for a business entity which enables registered individuals to increase their market share.

2. Legal Compliance With Regulatory Body: 

   It is crucial for guaranteeing regulatory compliance It is possible to incur substantial fines and penalties for failing to register for CDSCO online even when you are required to.

3. Assurance of Safety & Quality: 

   For the benefit of the customer's interest and protection, the CDSCO registration ensures the quality and safety of the medical equipment & products.

4. Allows Access to the Global Market:

    It allows you to tap the innovations and products in the global market and deliver the same in Indian markets.

Products Covered under CDSCO

Several products are covered under CDSCO license. Below is a list of the same:

Importance and Benefits of CDSCO With vs Without Registration

CDSCO registration can open several doors for your business. Below are the top benefits of a CDSCO license:

Beyond the obvious legal necessity, a CDSCO registration certificate tends to shorten sales cycles too procurement teams at hospitals and distributors ask for it upfront, and not having it on hand usually means the deal stalls before it starts.

CDSCO Online Process (SUGAM Portal)

Everything runs through SUGAM now the older cdscomdonline portal was phased out in January 2024 as CDSCO folded its systems into the National Single Window System. Here's how the process actually unfolds:

1. Register on SUGAM. Create an account as the applicant or as the Authorised Indian Agent, using a verified email and mobile number.

2. Classify the product correctly. This single step decides which form you file and how deep the review goes.

3. Assemble the dossier. Device Master File, Plant Master File, Free Sale Certificate, ISO 13485 certificate, and for higher classes clinical or performance data.

4. File Form MD-14 (for medical devices) or the relevant drug/cosmetics form, along with the prescribed government fee.

5. Answer CDSCO's queries. Deficiency letters are common, not a red flag respond fully and the review resumes.

6. Receive the license. Once satisfied, CDSCO grants the import license on Form MD-15 (or the equivalent registration certificate for drugs/cosmetics).

Timeline, Cost & Validity/Renewals

CDSCO have a limited validity and cost. Being aware of this makes the process easier to follow:

Government fee structure (medical device import):

A medical device import license under MD-15 doesn't expire in the traditional sense it stays valid indefinitely, but a retention fee is due every five years to keep it active. 

Difference Between Form MD-14 and MD-15

These two forms get confused constantly, mostly because they're two halves of the same transaction:

MD-14 is what you send to CDSCO, MD-15 is what CDSCO sends back once they've said yes.

Role of Agile Regulatory

Obtaining the CDSCO registration could be a bit challenging due to the complex process of the documents required and the processes involved. However, with the right amount of guidance and consultation, you could easily acquire CDSCO registration within the prescribed time. At Agile Regulatory we are committed to helping budding entrepreneurs by enabling them to acquire business licenses smoothly and carry on their business.