PHARMA - Medical Devices License
Your Regulatory Partner
Central Drugs Standard Control Organization (“CDSCO”) under Directorate General of Health Services,
Ministry of Health & Family Welfare is India’s apex drug and medical device regulator.
Drugs, cosmetics and medical devices are regulated under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules 1945. Manufacturing, import, sale and distribution of all medical devices in India are regulated under the Medical Devices Rules, 2017 (“MDR”) and amendments made thereof.
Drugs, cosmetics and medical devices are regulated under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules 1945. Manufacturing, import, sale and distribution of all medical devices in India are regulated under the Medical Devices Rules, 2017 (“MDR”) and amendments made thereof.
India’s CDSCO has Central Licensing Authority (CLA) and State Licensing Authority (SLA) with responsibility
for licensing to import, manufacture for sale or for distribution and sale, stock, exhibit or offer for sale.
CLA is responsible for licensing of import of all medical devices and manufacturing, loan and wholesale licensing of Class C & Class D medical devices.
SLA is responsible for manufacturing, loan and wholesale licensing of Class A & Class B medical devices.
CLA is responsible for licensing of import of all medical devices and manufacturing, loan and wholesale licensing of Class C & Class D medical devices.
SLA is responsible for manufacturing, loan and wholesale licensing of Class A & Class B medical devices.
CLASSIFICATION OF
MEDICAL DEVICES & IN-VITRO DIAGNOSTIC (IVD) MEDICAL DEVICES
Medical devices other than in vitro diagnostic
medical devices shall be classified on the basis of
parameters specified in Part I of the First Schedule
and In vitro diagnostic medical devices shall be
classified on the basis of parameters specified in
Part II of the First Schedule.
Each of these categories is classified into four classes based on the extent of risk associated with these devices.
Each of these categories is classified into four classes based on the extent of risk associated with these devices.
- Class A- Low Risk
- Class B- Low Moderate Risk
- Class C- Moderate High Risk
- Class D- High Risk
How
Mind Sync
Can Help?
Mind Sync’s regulatory services enable consumer products and medical devices companies to understand
and efficiently manage the demanding complexity of the diverse regulatory requirements to successfully
launch their products in new markets and maximize their market value.
Unlock the potential of Indian medical device manufacturing with Mind Syncs’ trusted excellence.
Unlock the potential of Indian medical device manufacturing with Mind Syncs’ trusted excellence.
Import & Manufacture of Existing Medical Devices
Import License
- Risk Class- A, B, C and D medical devices import license is granted by CLA.
- Application made in Form MD-14.
- Permission granted in Form MD-15.
Manufacturing / Loan License
- Risk Class- A and B medical devices manufacturing license is granted by SLA.
- Manufacturing license: Application made for Class A and B- Form MD-3, Permission in Form MD-5.
- Loan license: Application made for Class A and B- Form MD-4, Permission in Form MD- 6.
- Risk Class- C and D medical devices manufacturing license is granted by CLA.
- Manufacturing license: Application made for Class C and D- Form MD-7, Permission granted in Form MD-9
- Loan license: Application made for Class C and D- Form MD-8, Permission granted in Form MD-10.
QUICK ANSWERS
- Filing of Application- Application to be made to SLA in Form MD-3.
- Documents Submission- Documents to be submitted with the application.
- Audit of manufacturing site- No audit is required prior to grant of license for Class A medical device. Technical review and audit will be conducted within 120 days of grant of license. In case of Class B, the manufacturing site will be audited within 90 days from date of application to ensure compliance with the QMS Standards.
- Grant of license- Licence will be granted to manufacture Class A & B medical devices in Form MD-5.
- Device Master file;
- Plant Master file;
- Copy of Certificate supporting quality management system (ISO: 13485);
- Test License obtained for testing and generation of quality control data;
- Undertaking signed stating that the manufacturing site is in compliance with provision of Quality Management System (QMS);
- KYC documents, etc.
- Filing of Application- Application to be made to CLA in Form MD-7.
- Documents Submission- Documents to be submitted with the application.
- Audit of manufacturing site- the manufacturing site will be audited within 60 days from date of application.
- Grant of license- License will be granted to manufacture Class C & D medical devices in Form MD-9.
- KYC documents;
- Device Master file;
- Plant Master file;
- Copy of Certificate supporting quality management system (ISO: 13485);
- Test License obtained for testing and generation of quality control data;
- Undertaking signed stating that the manufacturing site is in compliance with provision of Quality Management System (QMS), etc.
- Small quantity of Class A, B, C and D medical devices may be manufactured for the following purposes i.e. Clinical Investigations, Test, Evaluation, Examination, Demonstration, Training;
- An application shall be made in Form MD-12 to the Central Licensing Authority;
- The application shall also be accompanied with the prescribed documents:
(a) Brief description of the medical device;
(b) List of equipment, instruments;
(c) List of qualified personnel;
(d) Copy of manufacturing license issued under Medical Device Rules, if any;
(e) Approval letter.
- The CLA shall grant a test license in Form MD-13.
- Appointment of AIR- An Authorised Indian Representative (AIR) must be appointed for import of medical devices. This agent must have a license to manufacture (for sale or distribution) or license to wholesale (sale or distribution) as per the Rules.
- Filing of Application- The AIR will make an application to CLA in Form MD-14;
- Documents Submission- Documents to be submitted with the application;
- Audit of manufacturing site- The Central Licensing Authority may cause an inspection of the overseas manufacturing site. The applicant needs to pay fee for the same;
- Grant of license- License will be granted to import Class A, B, C & D medical devices in Form MD-15.
- Overseas manufacturing site or establishment or plant registration;
- Quality Management System certificate or Full Quality Assurance certificate or Production Quality Assurance certificate, in respect of the manufacturing site;
- Wholesale licence or manufacturing licence of the Authorised Agent;
- Copy of latest inspection or audit report carried out by Notified bodies or National Regulatory Authority or Competent Authority within last 3 years, if any.
- Free Sale Certificate
- Plant Master File
- Device Master File, etc.
Central Drugs Standard Control Organization (CDSCO)
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This information is in summary form and is therefore intended for general guidance only. It is not intended to be a substitute for detailed research or the exercise of professional judgment. Mind Sync does not accept any responsibility for loss occasioned to any person acting or refraining from action as a result of any information provided herein. On any specific matter, reference should be made to the appropriate advisor.