How to get CDSCO NOC for Medical Devices?

Introduction

As per the WHO report, about 2 million medical devices of different categories are available globally. These can be apparatus, instruments, or machines used for medical purposes. There are multiple uses of medical devices used in hospitals, at home, in laboratories, etc. They are used in the treatment of diseases, monitoring chronic diseases, and many more. 
About Medical Devices in India
The Drugs and Cosmetic Act, 1940 and Rules formulated in 1945 determine notified medical devices as drugs. The sub-clause (i) of the Drugs and Cosmetic Act, 1940 and 1945 consists of devices namely, surgical bandages, surgical staples, ligatures, surgical sutures, blood collection bags, blood component collection bags and substances which are used in-vitro and in surgical dressings.

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Sub-clause (ii) contains disinfectants, insecticides and mechanical contraceptives which include tubal rings, condoms and intrauterine devices.  Under section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940 the lists of medical devices are updated on regular intervals. 
Role of Medical Devices Division of CDSCO

The department of medical devices discharges the following roles:

 1.    It grants a Certificate of Registration to any notified body (accredited by National Accreditation Body) to audit medical devices of Class A and Class B.
 2.   The department grants licenses to import medical devices.
 3.    It grants licenses or loan licenses to applicants to manufacture medical devices for the purpose of selling or distribution.
 4.   License to manufacture medical devices to conduct clinical investigations, tests, evaluations and other purposes is granted by this division of the CDSCO.
 5.   License to import medical devices to conduct clinical investigations, tests, evaluations and other purposes is granted by this medical       devices division.
 6.   This department also grants import licenses for investigational medical devices. The license to import investigational medical devices is  granted only if the application is given by a medical officer via a statutory medical institution or Government hospital. 
 7.   Permission is granted by this division of the CDSCO to perform a clinical investigation of investigational medical devices.
 8.   Permission is also granted to perform a clinical evaluation of a new in-vitro diagnostic medical device. 
 9.  It grants permission to manufacture or import medical devices which do have a similar kind.
 10.  Permission is given by this department to manufacturers or importers for the sale or distribution of the new in-vitro diagnostic medical device.
  11.  The medical device division checks the registration of applicants submitted for the medical device testing laboratory.
  12. It prepares instructions and FAQs on important issues.
  13.  It processes applications to issue Free Sale Certificate for domestic manufacturers.
  14.  The department processes applications to issue Market Standing Certificate and Non- Conviction for purpose of medical devices.
  15.  It looks after the constitution of the MD experts committee.
  16.  The department inspects the manufacturing area to comply with QMS by CLA/SLA.
  17.  The medical device division prepares and presents answers to Parliament questions/clarifications/RTIs/NOCs/Post Office queries.
  18.  Lastly, it clarifies doubts of applicants on the regulatory status of products. 

List of Medical Devices

Listed below are the medical devices mentioned in the Drugs and Cosmetics Act:

1.    Disposable Hypodermic Syringes 
2.    Disposable Hypodermic Needles 
3.    Disposable Perfusion Sets GSR 
4.    In vitro Diagnostic Devices for HCV, HIV and HBsAg
5.    Cardiac Stents 
6.    Drug Eluting Stents
7.    Catheters  
8.    Intra Ocular Lenses
9.    I.V. Cannula 
10.    Bone Cements
11.    Heart Valves 
12.    Scalp Vein
13.    Orthopaedic Implants 
14.    Internal Prosthetic Replacements 
15.    Ablation Devices

Steps for the Approval of Application for Medical Devices

    1. The applicants apply through the SUGAM portal regarding medical devices. 
    2. The application is then received by the Nodal Officer.
    3. After it is reviewed by the Nodal officer, the application is sent to the Reviewing Officer.
    4. Next, the application is forwarded to NO and then to DDA/DA to check the documents. In case there is any query or discrepancy, the     application is forwarded to the applicant to resolve the issue.
    5. The applicant resolves the issue found in the application which is then forwarded to LA for approval.

How to Register for Non-notified Medical Devices?

    1.  Visit the official portal of the CDSCO.
    2.  Click on the registration link.
    3.  Register by providing email id and phone number.
    4.  Upload documents like identity proof, details of corporate address (Certificate of Incorporation), and a copy of wholesale license and manufacturing license. 
    5.   An OPT will be sent to the registered phone number. Applicants must verify using the OTP to proceed further.

Important Documents for Registration of Medical Devices

For Manufacturers

    1. Name and address of the firm or company and name and address of the site where medical devices are manufactured.
    2. Following details of medical devices
    3. Generic name of the medical device
    4. Model number
    5. Use of the medical device
     6. Type of medical device
     7. The material used in the making of medical device
    8. Dimension and shelf life
    9. Whether the device is sterile or non-sterile
    10. Brand of the medical device
    11. Quality of medical device specification
    12. A certificate that complies with ISO 1348 standards and is accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum.
   13.  A declaration by the manufacturer.

For Importer

    1. Name of the firm or company.
    2. Following details of medical devices
    Generic name of the medical device
    Model number
    Use of the medical device
     Type of medical device
     The material used in the making of medical device
    Dimension and shelf life
    Whether the device is sterile or non-sterile
    Brand of the medical device
    Quality of medical device and specification.
    A certificate that complies with ISO 1348 standards and is accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum.
    Free Sale Certificate from the country where the medical device was made.
    Declaration by the importer.

Legal Documents Required to Import/Manufacture of Medical Device

   1. Cover letter with correct page number and index. Also, mention the purpose whether the application is for import or manufacture of the medical device.
   2. Applicant must issue a letter of authorization from the Director/Company Secretary/Partner of the Indian Agent firm. Submit a self-attested copy of the authorization letter. 
   3.  Submit product details, the material used in making the product, its use, specification, literature, package and sample.
   4. Status of the medical device in the country where it was made.
   5. Regulatory certificate of the medical device.
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