CSDCO MEDICAL
India is counted as one of the top global Medical Device markets with its major contribution from device imports. The Central Drug Standard Control Organization (CDSCO) regulates medical devices and In-Vitro Diagnostics (IVD) marketed in India. The CDSCO is headed by Drug Controller General of India (DCGI) and the approval authority is shared between Center Licensing Authority (CLA) and the State Licensing Authority (SLA).
We Provide Best Service For Your Company
Cosmetic Import Registration
India has emerged as the world's top manufacturer of medical devices over the past two decades. The Central Drugs Standards Control Organization (CDSCO) is authorised regulatory to approve applications to grant the permission to import medical devices in India. To import notified medical devices, an import license i.e., Form MD-15, must be procured from the CDSCO, as per the Medical Devices Rule, 2017. To import notified medical devices, the manufacturing site and medical devices should be registered with the CDSCO. The Medical Device import license can be obtained by filling Form MD-14 and submitting to the CDSCO. An authorized Indian agent must be appointed for the same. This agent must have a license to manufacture (for sale or distribution) or license to wholesale (sale or distribution) as per the rules. The agent will make an application for the grant of the import license by applying through the Sugam online portal.
An authorized Indian agent must be appointed for the same. This agent must have a license to manufacture (for sale or distribution) or wholesale License FORM 20B & FORM 21 B (sale or distribution) as per the CDSCO guidelines. The agent will make an application to get the grant of medical devices import license by applying through the Sugam online portal.
Procedure for License to Import of Medical Devices (Import - CDSCO)
1. Documentation – Preparation of documentation as per prerequisite document checklist and information as per Application form. For document Checklist please refer requisite form no. eg. MD-14, MD-16 etc.
2. User id Creation – Crate user id on Sugam portal of CDSCO with required documents.
3. Application to CDSCO – After verification of prepared documents, we will make an application to CDSCO. After application CDSCO official will review application and raising query if any.
4. Query reply – If any addition document required or submitted document is not accepted by Central Licensing Authority. So we need to submit revised documents as per query.
5. Grant of License – After verification of documents Central Licensing Authority shall grant import license as per application form.
License (Medical Devices and In-Vitro Medical Devices) – Import
For medical device mentioned in Annexure of eighth schedule which are notified as per
Medical Devices Rule 2017. Means that medical devices importer shall be granted import license from CDSCO before import such medical devices.
For import of medical devices following form available for application and approval of licenses.
1. Application for issue of import licence to import medical device in MD-14 and Licence to Import Medical Device in MD-15.
2. Application for Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training in MD-16 and Licence to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training in MD-17.
3. Application for licence to import investigational medical devices for the purposes by a government hospital or statutory medical institution for the treatment of patients in MD-18 and Licence to import investigational medical device by a government hospital or statutory medical institution for the treatment of patients in MD-19.
4. Application for permission to import small quantity of medical devices for personal use in MD-20 and Permission to import of small quantity of medical devices for personal use in MD-21.
5. Application for grant of permission to import / manufacture for sale or for distribution of medical device which does not have predicate medical device in MD-26 and Permission to import or manufacture for sale or for distribution of medical device which does not have predicate medical device in MD-27.
6. Application for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device in MD-28 and Permission to Import or Manufacture New In Vitro Diagnostic Medical Device in MD-29.
The documents required registration CDSCO
1. ID Proof Document
2. Undertaking issued by a Government Authority
3. Address Proof Document
4. Copy of BA/BE Site Registration as approved by CDSCO in case of BA/BE Approved sites Registration
5. Manufacturing License or Wholesale Licenses in case of Import or Manufacture of Drugs/Blood Product Registration/Test license Registration
Purposes For Which CDSCO Registration Can be Obtained
CDSCO can grant registration for different purposes. The different purposes for which an applicant can register under the CDSCO portal are:
1. Cosmetics Registration
2. Import or Manufacture of drugs
3. Export NOC (Zone)
4. Test License
5. Ethics Committee Registration
6. Formulation R&D Organisation
7. Blood Bank Registration
8. Blood Product Registration
9. Dual Use NOC (Trader)
10. BA/BE Approved Sites
11. Sponsors (BA/BE and CT)
CDSCO MEDICAL: FAQ
Ans: Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.
Ans: Yes, import, manufacture, sale and distribution of medical devices are regulated in India under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945.
Ans: The copy of the Drugs & Cosmetic Act 1940 & Rules 1945 is available in Link:http://cdsco.nic.in/Drugs&CosmeticAct.pdf
Ans: Drugs Controller General (India), Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India , FDA Bhavan, ITO, Kotla Road, New Delhi -110002 Phone: 91-11-23236965 / 23236975, Fax: 91-11-23236973, E-mail:- dci@nb.nic.in
Ans: Medical Device & Diagnostics Division, Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002, is responsible for registration/import of Medical Devices in India.
Ans: For the import of medical devices in India, Registration Certificate in Form 41 and Import License in Form 10 are required as per provisions of the Drugs & Cosmetic Act & Rules. For import of medical device, the manufacturing site and products (medical devices) are required to be registered with Indian drug regulatory agency (i.e. Central Drugs Standards Control Organization).
Ans: No, registration is not required for import of non-notified medical devices in India. However, the following devices are regulated as “Drugs” under Drugs and Cosmetics Act and Rules, hence registration and import license is required for import in to India. Blood Grouping Sera Ligatures, Sutures, Staples Intra Uterine Devices (Cu-T), Condoms, Tubal Rings, Surgical Dressing, Umbilical Tapes, Blood / Blood Component Bags.
Ans: Any person/firm/enterprise etc. having wholesale license and/or manufacturing license issued under Drugs and Cosmetics Act, 1940 and Rules 1945 can be an applicant for Registration and import of medical devices into India.
Ans. Applications for Registration/ Import License of Medical Device shall be submitted to the Drugs Controller General (India), Central Drugs Standard Control Organization (CDSCO), FDA Bhawan, ITO, Kotla Road, Delhi-110002. Phone: 91-11-23236965 /23236975. Fax: 91-11-23236973.
Ans: If the application is complete in all respects and informations specified in Schedules D-I and D-II are in order, the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate in From 41.
ECS CLIENTS
CLIENTS CONNECT WITH US
