Category: CDSCO Registration

The business of importing cosmetics from China can be highly successful. The most crucial factor is that you understand what you are doing. Almost all nations within the borders of Europe and the rest of the western world have laws governing the import of cosmetics.

China is the world’s second-largest consumer market for cosmetics. A career and business that can be highly lucrative is importing cosmetics from China. Find a reliable supplier using online resources or by paying a visit to the factory, negotiate a price, and place the order. However, before doing so, we must have Drug License Certification for your cosmetic products. That is, you should have a cosmetic import license in India. Therefore, before placing the order, let’s inform ourselves of some important laws and regulations pertaining to import cosmetics, aka how to import cosmetics from China.

An Overview of the Registration Process for Cosmetic Licenses

India’s Ministry of Health & Family Welfare has succeeded in bringing in cosmetics. According to Rule 21 of the Drug & Cosmetics Act, 1945[1], a mandatory registration certificate pertaining to cosmetic import license of India is required. The cosmetics items and products that are imported for sale in the Indian market and meant to be poured, rubbed, sprinkled, or sprayed on and applied to a human’s body for beautifying, cleansing, alerting the appearance, and encouraging attractiveness should be approved by the CDSCO (Central Drugs Standard Control Organization).

Who Is Authorized To Import Cosmetics From China?

1. Consequently, the manufacturer must have a registered office in India.
2. It is a manufacturer’s subsidiary agent.
3. The manufacturer’s authorized representative.
4. Additional Importers

Documents Needed For Importing Cosmetics from China

The following are a few necessary documents for the approval of cosmetics imports from China to India:

1. A request form.
2. a letter of application from the candidate;
3. a genuine copy of the power of attorney; a copy of the label; a valid import export code (I.E.C. );
4. the cosmetics product’s specifications and testing procedure;
5. if any package inserts
6. confirmation of payment for the mandatory registration costs;
7. a marketing authorization letter or a free sale certificate (F.S.C.); information on the cosmetics product to be imported, including chemical and safety data (Schedule D III);
8. a list of the names of the nations where the goods has received import authorization or registration;
9. Details regarding cosmetic items, brands, and the producer should be provided in soft copy.

How to Import Cosmetics in India from China?

The steps for obtaining permission to import cosmetics from China to India are as follows:

Step 1: Application Form Submission: Complete the cosmetic license application form, include information about the company, and send it to the Indian Ministry of Health & Family Welfare’s office of the Drugs Controller General of India.

Step 2: Payment of Registration Money: Pay the registration fee after submitting your application.

Step 3: Verification of the testing report and related documents: The inspection teams will check other important documentation and the test results of cosmetic products.

Reminder: The registration application will be submitted along with the proof of payment.

Step 4: Application processing timeline: Submission of the Form along with other required business documentation must occur within six months of the application date. The registration certificate is valid for three years after the date of issuance.

Requirements for Laboratory Testing For Import Cosmetics in India from China

The BIS periodically reviewed the Indian Standard and verified the quality of cosmetic products. Therefore, it is necessary to confirm that the cosmetic items meet Indian Standards. The following typical tests can be used to determine which cosmetic product is suitable for Indian consumers:

Performance testing: examines the cosmetic product’s functionality and durability.

Toxicology testing: examines the materials and completed cosmetic product to see if any components provide a risk to consumers, such as eye corrosion or skin irritation.

Microbiology testing: It enables various techniques to spot the presence of germs and confirm that something is free of dangerous microorganisms.

Chemical Stability Testing: This is the investigation of cosmetics product storage conditions and estimation of shelf life.

Safety testing: It’s similar to the presence of heavy metals in cosmetics, as well as restricted colors and substances.

Penalty for Violation of the 1945 Drugs and Cosmetics Act

A fine of up to Rs. 1000 or a year in jail, or both, may be imposed on the first offense for violating any of the cosmetics laws under this Act. On successive offenses, the sentence may be enhanced to 2 years in prison and/or a fine of up to Rs. 2000.

Therefore, in order to prevent any delays or application errors, importers of cosmetics from China must carefully follow the registration process and provide all necessary papers with their registration application.

Also read about:

Cosmetic Manufacturing License

Import License for Cosmetics in India

In order to regulate drugs and cosmetics, the Drugs and Cosmetics Act, 1940 and rules, 1945 have given central and state regulators a number of duties. It also envisions the uniform application of the Act’s provisions.

Rules made there under for ensuring the patients’ rights, safety, and well-being by regulating the drugs also, cosmetics. Objective of the CDSCO is to increase transparency, accountability, and uniformity in its services that guarantee the manufactured, imported, and/or use of medical products are safe, effective, and of high quality throughout the nation.

In order to support public health, the CDSCO Certificate in Public Health Domain performs a variety of tasks. For instance, the CDSCO is in charge of

1. Approving clinical trials,
2. Checking the quality of imported medicines,
3. Coordinating the work of state drug control agencies,
4. Offering professional advice to uphold the standards of the Drugs and Cosmetics Act, and
5. Issuing and renewing licenses for a variety of medical devices and drug categories.

Through its operations, CDSCO provides the general public with standards of quality and safety.

But do you really need a CDSCO issued license?

What Does a CDSCO License Mean?

It alludes to the permission to make or manufacture medicines, disposable medical equipment, or cosmetics in India. According to the CDSCO’s requirements for product registration, for example toxins don’t exist in any of the products. The items contain the permitted chemicals in the permitted concentrations.

Experts that are familiar with governmental regulations oversee the entire manufacturing process.

What does CDSCO Registration Serve?

The straightforward goal of this registration is to control goods that are produced or imported in India. The government is more worried about importers, though, as it is foreign products that are the source of its worries.

Regarding this accreditation, its goals can be broken down into SAR:

S is for Safety: Because the imported goods are intended for Indian citizens, the license guarantees that they don’t include any potentially dangerous ingredients.

A is for Assessment: The requirements for CDSCO SUGAM registration include a number of factors. According to those rules, the Organization must evaluate imported cosmetics and other items to make sure they adhere to regulatory requirements. The government has changed more regulations in the last ten years than it has since India gained independence.

R is for Regulations: Despite the modifications, the license guarantees that the importers follow the guidance provided by the government.

Types of CDSCO Registration

The following list includes some of the several grounds for which CDSCO may approve registration:

1. Cosmetics Import and Export NOC registration according to ethical standards
2. Development and Research of Blood Products and
3. Blood Bank Formulations with NOC for Dual Use
4. Authorized sites by BA/BE

The Role of CDSCO Certification in the Field of Public Health

A range of activities that are advantageous to public health are made possible by CDSCO accreditation. The tasks comprise:

1. Establishing requirements for medications, cosmetics, and medical equipment
2. Establishing legislative changes, regulations, and regulatory initiatives
3. To approve the sale of new medications
4. In India to control clinical trials
5. As the central license approving authority, to grant permits for the production of specific classes of medications, including Blood Banks, Medical Devices, r-DNA drugs, Large Volume Parenterals, and Vaccines & Sera
6. To control the requirements for importing drugs
7. Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee-related activities (DCC)
8. The Pharmacovigilance Program in India
9. providing policy direction and coordinating the efforts of state drug control agencies to ensure uniform application of the Controlled Substances Act
10. Involvement in the GMP certification programme run by the WHO
11. Keeping note of medicine side effects (ADR)
12. Organizing training sessions for regulatory and government analysts

But they do face challenges when they are serving in the public health domain. Let’s find out some more about this:

Obstacles That Must Be Addressed For Public Health to Improve

Following are some issues with drug regulating systems:

1. State-level drug control infrastructure that is insufficient or inadequate.
2. Drug testing facilities that is insufficient.
3. Application of laws and rules that is not uniform.
4. A lack of regulatory authorities’ training
5. There is no database.
6. Insufficient
7. IT services.

Conclusion

Especially for the prevention, diagnosis, treatment, and management of all medical disorders, diseases, illnesses, and impairments, the medical devices industry in India is a crucial and fundamental part of the nation’s healthcare sector. The Medical Device Sector was largely unregulated under the 1940 Drugs and Cosmetics Act until 2017, when the Central Drugs Standard Control Organization (CDSCO) passed the Medical Device Rules, 2017 for the comprehensive regulation of medical devices (M.D.s), with a focus on quality, safety, and efficacy

Also read about:

Import License for Cosmetics in India

CDSCO Registration for MRI Scan Machine

Drug License Delhi

A form of scan called an MRI, or magnetic resonance imaging, creates precise images of the body inside the scanner by combining radio waves and powerful magnetic fields. It is used to identify diseases, provide a diagnosis, and monitor their progression. The list of equipment and devices that will be treated as pharmaceuticals was announced by the Ministry of Health & Family, Government of India, for regulation in 2021. According to the order, manufacturers or importers of equipment and medical devices, such as MRI machines, CT scan machines, x-ray machines, dialysis machines, etc., as well as all implantable medical devices, will need to obtain a manufacturing or import license from the State Licensing Authority or Central Licensing Authority, respectively. We shall talk about CDSCO Registration for an MRI scanner in this article consisting of Process, documents needed and how Regalguru can help in acquiring the said registration.

CDSCO Registration of Medical Devices

India is one of the countries with the fastest-growing pharmaceutical industries, thanks to a number of variables including its sizable population, reasonably priced healthcare options, rising public health consciousness, and improved research infrastructure. However, there is a chance that medical devices and equipment would be sold or bought illegally due to the expansion of the pharmaceutical business in India.

Because of this, the Indian government established CDSCO (Central Drug Standards Control Organization), which serves as the country’s principal legislative body and is in charge of managing and regulating the country’s pharmaceutical and medical device industries.

Documents Needed to Register an MRI Scanner with CDSCO

The following are some important documents needed to register an MRI scanner with CDSCO:

1. Application form completed in full,
2. A CE Design Certificate,
3. A plant master report, and
4. A device master file; pledging that all the information provided by the application is true and accurate
5. Full certificate of quality assurance
6. Obtain a Free Sale Certificate (FSC) or a certificate from a foreign government;
7. Information about the actual place;
8. The manufacturer’s name, address, and contact information.

The Process for Registering an MRI Scanner with CDSCO

The steps for CDSCO registration for an MRI scanner are as follows:

Step 1: Determine whether the necessary medical device is in the notified list of medical devices: A list of notified medical devices that must be registered under the 1940 Drugs & Cosmetics Act and the 2017 MDR has been supplied by the CDSCO. Any medical devices that haven’t been notified by the CDSCO or any new medical devices in India require a NOC from the maker or importer in these circumstances.

Step 2: Select an IAA (for Foreign Entity or Manufacturer): It is required that foreign manufacturers appoint an IAA (Indian Authorized Agent) in India. This person will act as the manufacturer’s point of contact for inspection authorities during the CDSCO Registration for MRI Scan Machine process and will assist with registration, device approvals, and vigilance adverse event reporting. The Indian Authorization has to be licensed to sell wholesale drugs.

Step 3: Filling out the Application Form: The MRI Scan Machine’s manufacturer or importer must submit the Registration Form on the CDSCO website together with the necessary paperwork & the needed money in this step.

Step 4: Registration Certificate Issuance: The authority may send a question via an inquiry letter representative after the applicant submits the application form, supporting documents, and payment of costs. The authority may grant a license once it is satisfied. The manufacturer or his/her authorized agent may submit an application for an importer license after receiving CDSCO Registration for an MRI Scanner.

Note: The CDSCO Registration for an MRI Scan Machine is good for three years from the day the Registration Certificate was issued, unless the DGCI authority suspends or cancels it.

CDSCO Registration for an MRI Scanner Must Be Renewed

At least nine months before the CDSCO Registration for MRI Scan Machine’s expiration date, the renewal application must be submitted. Although no additional paperwork is needed for the renewal of Registration, the Certificate Owner shall be required to submit a copy of the PMF (Plant Master File) & Device Master File or DMF.

Conclusion

The Indian MRI equipment market has 290 units and a volume of Rs. 1778.5 crore in 2019; it is anticipated to expand further in the coming years. The market for medical devices in India is anticipated to rise as a result of more new product launches and technical developments. A medical device registration is required because an MRI scanner falls into the Class II (moderate risk) category of medical equipment.

Also read about:

CDSCO Registration for Import of cosmetics

Medical Device Regulation FAQ

Drug licensing is a laborious process, especially in light of the pandemic. The severity of the difficulty involved in acquiring a drug license is indicated by the stringent regulatory standards established for issuing one. The fundamental regulatory framework that controls the entire drug licensing lifecycle is the Drugs and Cosmetics Act of 1940.

Conditions to Apply for a Drug License

For those who want to obtain a drug license, there are a number of requirements that must be met. It is crucial to make sure that all conditions are met given the low success rate of drug license grants, particularly for applicants seeking retail sales permits.

The Three Primary Requirements Are As Follows:

1. Existence of necessary space: This requirement relates to the pharmacy’s location or, in the event of a wholesale business, its point of sale.
2. Adequate drug storage space: Some medications need to be kept at low temperatures in order to be effective.
3. Trained and competent personnel: It is necessary to have qualified employees on board before submitting a licensing application.

Document Required for a Retail Drug License

The availability of proper buildings, cooling facilities, and qualified employees are the fundamental prerequisites for submitting an application for a drug license. The main document needed is a Form 19 that has been completed. This application seeks approval for a license to distribute, sell, stock, or offer to distribute medicines. These medications must not, however, be ones that are on Schedule X. Form 19A must be filled out by dealers who want to sell drugs in a retail setting without the help of a licensed person. To store, sell, or distribute homeopathic medications, Form 19B is necessary. People who want to sell Schedule X drugs must fill out Form 19C in the meantime.

List of Documents for New Retail Drug License

01. Form No. 19

02. Challan Rs. 3000/-

03. Affidavit of proprietor on stamp paper of 20 Rs.

04. Educational certificate copies of proprietor (Self attested)

05. Self attested copies of Identity proof of proprietor (Domicile/ driving license/ Voter ID card)

06. Affidavit of Regd. Pharmacist.

07. Educational certificate copies of Regd. Pharmacist (Self attested)

08. Self attested copies of Identity proof of Regd. Pharmacist (Domicile/ driving license/ Voter ID card)

09. Blueprint of Plan layout of proposed area/ premises

10. Electricity bill of proposed area/ premises.

11. Copy of Refrigerator bill.

12. Rent agreement (50 Rs. Stamp paper)

13. Ownership document of the premises including the copy of tax receipt of proposed area/ premises.

14. Covering letter.

15. Photo 5-5 each of Regd. Pharmacist and proprietor.

All Documents in PDF format scanned in GRAYscale.

List of Documents for New Wholesale Drug License

(Drug License No. 20B, 21B)

(Proprietor + Competent person)

01. Form No. 19

02. Chillan Rs. 3000/-

03. Affidavit of proprietor on stamp paper of 20 Rs.

04. Educational certificate copies of proprietor (Self attested)

05. Self attested copies of Identity proof of proprietor (Domicile/ Driving license/ Voter ID card)

06. Affidavit of Competent person.

07. Educational certificate copies of competent person (Self attested)

08. Self attested copies of Identity proof of competent person (Domicile/ Driving license/ Voter ID card)

09. Experience certificate of competent person. (Experience certificate of 4 years after 12th or experience certificate of 2 years after graduation in original)

10. Blueprint of Plan layout of proposed area/ premises.

11. Electricity bill of proposed area/ premises.

12. Copy of Refrigerator bill.

13. Rent agreement (50 Rs. Stamp paper)

14. Ownership document of the premises including the copy of tax receipt of proposed area/ premises.

15. Covering letter.

16. Photo 5-5 each of competent person and proprietor.

All Documents in PDF format scanned in GRAYscale.

Help With Obtaining a Retail Drug License from Regalguru

1. Buy a Plan for Professional Assistance
2. Questions Additional to Retail Drug License
3. Deliver Documents to the Regalguru Expert and finish all tasks
4. Finish your work now!

Also read about:

How to get Wholesale drug license

In India, the pharmacy industry is flourishing. The government frequently modifies regulations that help streamline the procedures in order to protect consumer safety. The primary step in beginning drug production is securing a wholesale drug license in Delhi from the relevant authorities.

The 1940 Drugs and Cosmetics Act sets the requirements for getting an Indian manufacturing license. Anyone interested in applying for a license from the Food and Drug Administration must submit the necessary paperwork to the State Licensing Authority and apply wholesale drug license online.

India Needs a Wholesale Drug License

Pharmaceutical manufacturing, distribution, sale, or storage all requires a wholesale drug license. The license serves as proof that you are a legitimate individual operating a legitimate pharmaceutical manufacturing or distribution business.  Apart from these, wholesale drug licenses have also these many benefits-

1. The authority is capable of monitoring the working
2. Business Admissibility

A person is required to submit a wholesale drug license application form since it gives the company legal standing.

3. Evidence of Authenticity

A Manufacturing Drug license is essential since it serves as proof of legitimacy and enhances the company’s reputation in the marketplace.

4. Increases the Customer Base

Also read about medical device registration in India

How to Get Wholesale Drug License?

The following steps must be taken to apply for a wholesale drug license online apply:

1. Lookup for a pharmacist
2. Compulsory document filing
3. Registration on a portal Registration of pharmacists on the platform
4. Application completion
5. Pharmacist with registration mapping
6. Submitting an application and paying fees
7. Examining the application
8. On-site drug inspector inspection
9. Issuing a license

Step 1: Finding a pharmacist for their business who will serve as the technical person for the firm is the first stage in the license application process.

Step 2: Before completing the application, all required paperwork must be organized. The following documents are included in the obligatory document set:

1. Plan of the property’s layout
2. Invoice for any required cold storage equipment
3. Proof of existence
4. GST Registration
5. Purchase contract or rental agreement
6. A picture of the applicant
7. ID and address verification for the applicant
8. Applicant’s certification of qualifications

Step 3: After ensuring that all required paperwork is in order, a user account needs to be set up on the state drug and food authority’s official website.

Step 4: After registering with the Food and Drug Authority, the applicant’s entity must then register its pharmacist with the department and create a special reference number for it. When submitting an application, the same number will be used.

Step 5: The following section of the portal post to complete the online pharmacy registration form, the application for a license to sell drugs wholesale. All of the Mandatory information and documentation must be submitted in their appropriate fields on the webpage.

Step 6: The most important step in the application filing serves to identify the licenced pharmacist in the application using the special reference ID.

Step 7: The last step of filling out an application is to submit it to the department and pay the associated fees for it in accordance with the rules. The applicant receives an acknowledgment after paying the fees.

Step 8: The application is reviewed by department authorities after it has been submitted and the necessary costs have been paid. If any errors or questions are discovered, the department posts a concern online and requests a response within a certain amount of time that addresses the matter.

Step 9: Following the department’s approval of the online application and the satisfactory resolution of all queries. The Drug Inspector conducts an on-site examination at the location where commercial operations are taking place. The drug inspector confirms that all company information is exactly as it was stated in the application. As soon as the officer is pleased with the inspection and the applicant has successfully completed all checkpoints during the inspection. The license application is forwarded by the DI.

Step 10: The DLA (Drug Licensing Authority) completes the wholesale license in the name of the company after a positive inspection. The applicant can begin commercial operations only after receiving the final license.

Why Do You Need Regalguru?

The drug license remains in effect indefinitely unless it is terminated by the drug inspector for whatever reason; however a retainer fee must be given every five years. With the necessary documentation and qualifications in order, the application procedure can be completed quickly and entirely online.

But it can get tiresome at one point. So give this headache to us and grow your company. We will be delighted to help you in getting your license.

Also read about CDSCO cosmetic import license

1. What is Voluntary Registration of Medical Device and When It Is Required?

The Indian Government changed the law in 2020 so that producers and importers of all medical equipment, excluding the 37 categories of medical devices, must voluntarily register by October 1, 2021. Manufacturers and importers who are unable to register before October 1, 2021 would have to either stop selling the relevant medical devices until they do so, or run the risk of incurring fines for breaking DCA and MDR regulations.

Class A and B medical device registration will be required starting on October 1, 2022. Class A and B device registration is initially optional for 18 months before becoming mandatory for 12 months. Class C and D medical device voluntary registration will be valid through September 30, 2023. The requirement for registration will take effect on October 1, 2023. Manufacturers or importers are required to register Class C and D devices for 24 months after 18 months of voluntary registration of medical device in India.

2. Does Medical Devices Require Registration in India and Why?

Only 40 to 50 medical devices in India presently need to be registered, and the Manufacturer is required to obtain a NOC from the DCGI for all other devices. The main goals of regulation are to prevent access to harmful items and to provide patients with high-quality, safe, and effective medical equipment. Regulation ensures the benefit to public health as well as the security of patients, medical personnel, and the general public when it is properly applied.

3. What Is The Process For Application For Registration Of Medical Devices In CDSCO?

Step 1: A Form 27 application must be submitted to the SLA (State Licensing Authority) along with the required fee in the amount and format specified in the proposed Rules, as well as a copy to the DCG Office.

Step 2: From the moment these rules were published, applicants would have 60 days to submit their applications for manufacturing.

Step 3: No manufacture will be allowed moving forward without the competent authority’s approval in accordance with the standards prescribed.

Step 4: The applicant must submit necessary information to the licensing authorities with their application.

Step 5: The expert committees will thoroughly analyze any medical devices that are being examined and don’t yet have any benchmark certification.

Step 6: The committee submits its recommendation for the acceptability of the gadget after conducting its evaluation.

Step 7: The SLA would submit the license to CLAA for approval following the joint verification and inspection.

Step 8: Following proper CLAA clearance, the license will be given in accordance with Form 28 of the aforementioned guidelines.

4. How Are Medical Devices Classified In India?

The MDR 2017 Guidance serves as the foundation for the classification system used in India, which is based on factors such as intended use, risk level, distribution mode, and level of bodily intrusion. From lowest to highest risk, products are categorized into one of the following categories:

A, B, C, and D are the different classes.

5. How Do I Register A Non-Notified Medical Device In India?

According to the provisions, a person must submit an application through a Sugam online portal in order to get the registration number of a medical device that has not been notified.

Steps that Manufacturers and Importers Must Take to Register Non-Notified Medical Devices

1. The applicant must click the portal’s registration link to register.
   1. https://cdscomdonline.gov.in/NewMedDev/Homepage
2. The applicant must register using a working email address and mobile number.
3. To register on the platform, candidates must upload the following documents:
   1. Id Proof Information
   2. Details of the corporate address proof (Certificate of Incorporation)
   3. A copy of the wholesale licenses and the manufacturing licenses (If not then upload the justification for the same)
4. The applicant must use the OTP (4 digits) obtained on their mobile device to confirm their registration before they can log in.
5. Candidates must upload the appropriate paperwork in accordance with the Registration Number checklist.

Also get detail about CDSCO cosmetic import registration