Manufacturing Registration for CDSCO Medical Devices

CDSCO Medical Devices
Ganesh Nair
| Updated: Aug 27, 2022 | Category: CDSCO

India is one of the biggest exporters of medical devices in the world. Earlier, there were laws to regulate medical devices in India. After 2006, The medical devices circulating in India must comply with the rules laid down by the Indian Medical Device Regulations. we discuss CDSCO Medical Devices.

Two regulatory bodies look after manufacturing registration for CDSCO medical devices; these are:

  • Drug Controller General of India (DCGI)[1]
  • CDSCO (Central Drugs Standards Control Organisation)

Classification of CDSCO Medical Devices

Medical devices under the CDSCO can be divided into two categories; these are:

  • Notified Medical Devices: CDSCO has 37 devices that require prior approval before being sold in India. Certification of such devices is mandatory as stated by rule 4 of the Medical Devices Rules, 2017.
  • Non-Medical Devices: There are no specific regulations for non-medical devices; these can be registered voluntarily with Central Licensing Authority (CLA) as per the medical Device (Amendment) Rules.

For which devices the Manufacturing Registration can be obtained.

S.no Products
1. Hypodermic Syringes (single-use)
2. Disposable Hypodermic needles
3. Perfusion sets (disposable)
4. Cardiac Stents
5. In-vitro devices for (HIV, HBsAg  and HCV)
6. Catheters
7. Drug-eluting Stents
8. Intra Ocular Lenses
9. I.V Cannulae
10. Bone types of Cement
11. Heart Valves
12. Scalp Vein Set
13. Orthopaedic Implants
14. Prosthetic replacements
15. Ablation Devices

Which entities can apply for Manufacturing Registration for CDSCO Medical Devices?

Entities that can apply for Manufacturing Registration for CDSCO Medical Devices are mentioned below:

  • An Entity has an office listed in India
  • The authorised agent, through the permission of the manufacturer
  • Any subsidiary of the manufacturer
  • A domestic medical device manufacturer
  • Any other importer.

Details to be declared to get Manufacturing Registration for CDSCO Medical Devices

Manufacturing Details:

  • Documents of the company such as :
    • Memorandum of Association & Article of Association
    • Partnership deed in case of partnership company
    • Declaration regarding the names of proprietors/ Directors/ partners etc.
    • Residential address and identification documents of all the partners and directors
    • Documents for ownership of the site/rent agreement (if the site is taken up on rent)
  • A Plant Master File prepared as per the requirements mentioned in appendix 1 of Part III of the fourth schedule) Along with this following documents should be attached to the file
    • Declaration of Manufacturing and Analytical Chemist.
    • Documents of work experience, qualification, appointment letters, Identification of Chemists.
    • Consent to operate from the state where the factory is located
    • Registration certificate from District Industries Centre.
  • A brief explanation of the manufacturing of the medical devices.
  • Documents showing the standards followed by the company for manufacturing and product evaluation
  • A copy of the certifications of devices. For example, the ISO certification

Product Details:

  • Name of the brand or proprietor
  • A concise description of the devices
  • Category of the device
  • The proposed use and method
  • In which speciality medical speciality device shall be utilised.
  • The quality and the quantity details of the constituents
  • Details of the materials used
  • Details of the procedure and standards used for testing the device
  • Contraindications, warnings, precautions, potential adverse events and alternate therapy, wherever applicable.
  • A descriptive explanation of accessories/other devices to be used along with the product.
  • Details regarding the stability of the device
  • Information regarding the results of clinical trials
  • If there are any variations in style, shape, or size of the device- if it is applicable
  • Labelling details of the product should conform with the Drugs and Cosmetics Rules 1945.
  • Promotional literature and physician manual in English (if any)
  • Sizes and description of the packaging and the packet sizes.
  • Conditions for storage
  • Summary of any problems that are reported.

Procedure to obtain Manufacturing Registration for CDSCO Medical Devices

Let’s have a look at the procedure for CDSCO medical device registration:

  • An application is to be made to the state licensing authority to manufacture the notified devices in Form 27.
  • The application form should be accompanied by the fee as stated in the rules, and the manufacturer must send a copy of the application to the office of DCGI
  • The applicant must provide the following details to the authorities along with the application.
  • In case the medical device does not have an evaluation procedure or any benchmark for certification. Then an expert committee shall be set up. This committee shall examine all the information about the device provided by the applicant to examine the product.
  • After properly assessing the device, the committee shall forward its observations and opinion to the competent authority. The authority, if satisfied, shall grant permission to release the device on the market.
  • The Centre licensing Authority and State licensing authority shall conduct a final joint inspection and verification of the product.
  • If the CLA is satisfied with all the rules and device configurations, it shall issue the license in Form 28.

Conclusion:

The Central Drug Standard Control Organisation regulates the registration of medical devices. If a manufacturer wants to get his device registered. In that case, he must make the necessary declarations, submit the application form in the prescribed format and comply with all the norms laid down by the CDSCO.

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Ganesh Nair

Ganesh Nair completed his graduation in law from IP university. He is an ardent researcher who has written various research papers and articles on contemporary legal issues. His keen interest in the field of research made him pursue a career in legal research. His core area of interest include Cyber, IPR and Finance laws.

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