CDSCO License

CDSCO

Class-A Medical Device Manufacturing Business in India

calendar05 Feb, 2024
timeReading Time: 6 Minutes
Class-A medical device

The regulatory approval and registration of medical devices by the CDSCO under the relevant authority regulate their categorization by the CDSCO. In India, medical device regulations are based on the 1940 Drug and Cosmetics Act and the 1945 Drugs and Cosmetics regulations. This applies to all medical devices. The CDSCO classification system provides a collection of risk categories for various items for medical devices. Moreover, CDSCO and state authorities are in charge of licensing medical equipment that falls into many categories, such as blood collection tubes, IV sets, in-vitro diagnostic items, etc.

How to Start a Medical Device Business in India?

In India, starting a medical device business in India requires a number of processes, one of which is registration. The laws and procedures are subject to change, and it is advised to be updated with the same. Therefore, confirming the most recent details is important by visiting the government site and the appropriate authorities.

1. Registration of Company:

  • Decide on a Company Structure: Select the business form you wish to start for a company registration for a Class-A medical device business. You can choose from a limited liability partnership (LLP), private limited company, partnership, or sole proprietorship.
  • File an application with MCA, the Ministry of Corporate Affairs: A business entity can be registered with the MCA. Getting the directors’ Director Identification Number (DIN) and Digital Signature Certificate (DSC), etc, for a Class-A medical device business.

2. Registration for Goods and Services Tax (GST):

  • File a GST application: You must register for GST with the Goods and Services Tax Network (GSTN) as a Class-A medical device subject to GST law. The official GST site is the online site for doing this.

3. Medical Device Registration Under Class-A Medical Device:

  • Identify the Regulatory Authority: The Central Drugs Standard Control Organization (CDSCO) is India’s medical device regulating organization for the classification of the Class-A medical device.
  • Classify Your Medical Device: Risk-based classifications group medical devices into several groups. Sort your medical device and be aware of the paperwork needed to register it.
    • Get paperwork Ready: Compile the required paperwork, which should include information on the product, the manufacturing procedure, quality assurance, and, if relevant, clinical data.
    • Important forms necessary for Class-A medical device manufacturing: The State Licensing Authority regulates the Manufacturing License for Class-A medical device sales and distribution. Forms MD-3 and MD-5 are used to apply for a license; the license is obtained in Form MD-5, and the applicant must submit an application in Form MD-3 with the required documentation.
    • Submit Application: Send the application for medical device registration to the CDSCO or the appropriate authorities. Inspections and evaluations can be part of the registration procedure.

4. ISO Certification: Obtain ISO Certification:

Manufacturers of class-A medical devices frequently need to obtain ISO certification. The standards for a quality management system tailored to the medical device sector are outlined in this international standard. Obtain your certification from the certifying authority.

5. Compliance with Other Standards:

Ensure that you comply with any other applicable rules and guidelines that are particular to the medical device sector. Performance and safety requirements are also a part of this.

What do you mean by a Medical Device?

An item, tool, equipment, or apparatus used for detecting, measuring, repairing, changing, or restoring the body’s structure or function for a health purpose or for preventing, diagnosing, or treating illness or disease.

Who needs a CDSCO registration?

The candidates listed below are eligible to apply for an online CDSCO registration in India:

Indian agentsImporters
CorporationsForeign Companies and their subsidiaries.

A manufacturing facility is unable to sign up directly through the portal or website. To access the site, a company must set up login credentials for the production unit.

Classification of Medical Devices

The application form for an Indian manufacturing license for medical devices uses these classifications of medical devices. Applications for various sorts of medical equipment are submitted using different forms. The CDSCO site offers an online option for completing the process. After the procedure is finished, a certificate for permission to manufacture these medical devices for different classes is given.

The Central Licensing Authority of India, or CDSCO, classifies medical equipment. Medical devices that are not in-vitro diagnostic equipment are categorized according to:

  • Risk
  • Purpose
  • Length of contract
  • Invasiveness: surgically invasive, non-invasive, and invasive with regard to bodily openings

Medical devices that are not in vitro diagnostic equipment fall into one of the following categories:

  1. Class A medical equipment with little risk
  2. Class B medical device with low to moderate risk
  3. Medical device class C, somewhat high-risk
  4. Class D medical device at high risk

Class-A Medical Device

  Class  Medical Device
Class-A Medical DeviceSurgical dressing
  Class-A Medical Device  Alcohol swabs
  Class-A Medical Device  Bolster suture
  Class-A Medical Device  Umbilical occlusion device
  Class-A Medical DeviceNasopharyngeal Catheter/ Nasopharyngeal
  Class-A Medical Device  Y-Connector as an accessory to perfusion sets

Regulating Authorities for CDSCO

  • Central Drug Standard Control Organization CDSCO

The Central Drug Standard Control Organization (CDSCO), which is overseen by the Directorate General of Health Services under the Ministry of Health & Family Welfare, is the top regulatory body for pharmaceuticals, IVDs, and medical devices. The Central Licensing Authority of India, or CLA, is another name for it.

  • India’s Drug Controller General (DCGI)

In addition to approving the standards and quality of medications, medical equipment, and cosmetics for sale, import, or manufacture in India, the head of CDSCO oversees clinical studies.

  • The Rules and Drugs and Cosmetics Act

The Drugs & Cosmetic Act and Rules regulate the process of manufacturing, importing, and distributing.

  • State Board of Licensing

The regulatory agency in charge of granting medical device manufacturing licenses to devices with Class A and medium risk classifications is known as the State Licensing Authority or SLA. It grants permits for Class-A medical devices and Class B. Class-A medical devices in India. Class B medical device manufacturing, lending, and wholesale licenses may be issued by the State Licensing Authority. It gives a Notified Body permission to examine the Quality Management System and Technical Review of producers of Class-A medical devices and Class-B medical devices.

CDSCO Registration with Corpbiz

Working with a knowledgeable consultant can expedite the clearance process for your medical device considerably. Corpbiz experts are well-versed in managing deadlines, creating plans, attending meetings, negotiating a variety of regulatory requirements, and more. Testing is essential to make sure your class-A medical device satisfies regulatory requirements. Experienced consultants have access to cutting-edge technological solutions that can expedite the approval process by streamlining the testing procedure.

Conclusion

Over time, the laws and regulations governing medicine in India have grown more intricate. In India, there was no such authority to control drugs, medical devices, or other things connected to medicine. However, the CDSCO now handles every duty related to policing and overseeing these kinds of operations. In India, there are several types of gadgets that need to be registered. Only regulated devices must apply for registration in the difficult procedure of medical device registration. A producer producing medical equipment is required to adhere to stringent protocols and standards established by the Central Drug Standard Control Organization (CDSCO). The relevant authorities are primarily responsible for enforcing and managing the New Medical Device Rules. In order to guarantee consistent rule enforcement, CDSCO collaborates with the authorities.

Frequently Asked Question

1. What medical devices fall under classes A and B?

Medical devices classified as low-risk or moderate-risk fall under Class A and Class B. The CDSCO requires a manufacturer’s license from any business that plans to produce certain medical devices for retail or distribution.

2. Where can I apply for a CDSCO import license for medical devices?

A medical device import license in India is granted by the CDSCO, which is housed inside the Ministry of Health & Family Welfare’s Directorate General of Health office. To get an import license under MD-15 to import medical devices, the applicant must submit an MD-14 application through the CDSCO web portal.

3. In India, what license is necessary to market medical devices?

The applicant must first get a manufacturing license and an MD 41 (Wholesale License) in order to sell or distribute medical equipment. In order to obtain approval from the State Licensing Authority, depending on their location, applicants must utilize the online portal maintained by the Ministry of Health and Family Welfare.

4. Where can one obtain a license to import medical devices?

The regulatory authority oversees the licensing through the Ministry of Health & Family Welfare. The online gateway for CDSCO Registration, which is required to get an import license, has been validated by the Ministry.

5. For what duration are medical device licenses in India valid?

Import class-A medical device licenses are good for five years. Applicants must submit updated documentation and the necessary payments in order to renew their license.

6. Which cities are home to CDSCO’s zonal offices?

Mumbai, Ghaziabad, Kolkata, Hyderabad, Chennai, and Ahmadabad are the locations of its six zonal offices.

7. Does CDSCO have legislative protections?

The Central Drug Regulatory Council of India, or CDSCO, is a state-level statutory institution that answers to the Ministry of Health & Family Welfare.

8. In India, who authorized medical devices?

The Ministry of Health & Family Welfare’s Drug Controller General of India, or DCGI, works with the CDSCO to regulate and control medical devices.

9. Do my class-A medical devices need to be registered in India?

Yes, all Class A, B, C, and D medical devices will need an MD-14/MD-15 import license from the CDSCO beginning on October 1, 2023, in order to be imported into India. Non-measuring/sterile Class A items do not need an import license, but they do need to be registered online.

10. Is ISO 13485 a requirement in India for medical devices?

As part of the application procedure, the legal and/or real manufacturing facilities’ quality system(s) must be certified by ISO 13485.

Read our Article: Different Classes Of Medical Device & Their Risk Levels – An Overview

CDSCO License

Request a Call Back

Are you human? : 5 + 8 =

Easy Payment Options Available No Spam. No Sharing. 100% Confidentiality