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**Executive Summary:**
This document from the Central Drugs Standard Control Organisation (CDSCO) clarifies procedures and requirements related to Medical Devices and IVDs, based on the Medical Device Rules 2017. It addresses queries about obtaining additional product licenses, GMP compliance, and the issuance of various certificates. The document refers to FAQs published on the CDSCO website for further guidance and aims to ensure smooth functioning of MDR 2017.
**Key Points / Main Content:**
* **Additional Product Licenses:**
* To obtain licenses for additional products in similar categories of Medical Devices/IVDs after 01.01.2018, applicants must submit the application form, fees, and required documents.
* **GMP Compliance:**
* Compliance to Good Manufacturing Practices (GMP) as per the Medical Device Rules, 2017, is applicable to medical devices and IVDs.
* **WHO GMP Certificates:**
* The Licensing Authority that issued the original manufacturing license will continue to issue WHO GMP certificates, but only upon the request of the importing country.
* **Other Certificates:**
* The Licensing Authority will issue other certificates (e.g., Non-Conviction, Validity, Market Standing) as required by procurement/tendering agencies, even if not explicitly mentioned in the rules.
* **Further Information:**
* Stakeholders are advised to refer to the Frequently Asked Questions (FAQs) on the CDSCO website for clarifications and to ensure smooth functioning of MDR 2017.
**Impact Analysis:**
* **Manufacturers of Medical Devices and IVDs:**
* *Impact:* Affected by the clarified procedures for obtaining additional product licenses, GMP compliance requirements, and the process for obtaining necessary certificates.
* *Action Required:* Ensure compliance with GMP standards, follow the specified application procedure for new product licenses, and request necessary certificates from the Licensing Authority as needed.
* **Licensing Authority (State Drugs Controller/CDSCO):**
* *Impact:* Responsible for issuing WHO GMP certificates (upon request of importing country) and other certificates required by procurement/tendering agencies.
* *Action Required:* Continue to issue WHO GMP certificates and other certificates as needed, based on established procedures and requests.
* **Importing Countries/Procurement Agencies:**
* *Impact:* Need to request WHO GMP certificates directly to the Licensing Authority.
* *Action Required:* Ensure any request for a WHO GMP certificate is directed to the approriate authority.
* **Stakeholders (General):**
* *Impact:* Affected by the clarifications and guidance provided in the FAQs related to Medical Device Rules 2017.
* *Action Required:* Refer to the FAQs on the CDSCO website for further information and clarification.
Key Entities Referenced
Central Drugs Standard Control Organisation: A national regulatory body for pharmaceuticals and medical devices under the Ministry of Health and Family Welfare, Government of India.
Medical Device Rules 2017: The regulatory framework governing medical devices in India.
WHO GMP certificate: World Health Organization Good Manufacturing Practice certificate issued for medical devices.
Licensing Authority: The authority responsible for issuing licenses for manufacture and sale of medical devices.
New Delhi: The location of Central Drugs Standard Control Organisation office.
GMMDP: Good Manufacturing Practices and Medical Device Production Requirements
Dr. V.G. Somani: Joint Drugs Controller
Gujarat: State in India where some manufacturers are located, as indicated by an address in the document.
No.
29/Misc/03/2018-DC(59)
Government of India
Central Drugs Standard Control Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Device & Diagnostic Division)
FDA Bhawan, Kotla Road,
To, New Delhi-110002, Datedy
08
9
AUG
yy),
28
All State Drugs Controller
All Zonal/ Sub Zonal office of CDSCO
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I AV nD ss : ? Licensing Authority who has issued the valid license to manufacture for sale will
continue to issue WHO GMP certificate (Only on the request of importing country)
Q.No.64.. Who will issue the other certificates like Non-Conviction Certificate,
Validity Certificate, Market Standing certificate etc. which are not mentioned in rules
but are required on request of procurement / tendering agencies?
Ans: The Licensing Authority who has issued license shall issue such certificates.
Further in case of any query, it is requested to refer to FAQ for ensuring smooth
functioning of MDR-2017 and solving the stakeholder’s queries.
Yours faithfully,
“7
(Dr. V.G. Somani)
Joint Drugs Controller (1)
Copy to :- AIMED- 901-902, Narain Manzil, 23, Barakhamba Rd, Barakhamba, New Delhi- 110001
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Confederation of Indian Industry (Cll)
The Advanced Medical Technology Association (AdvaMed)
The Federation of Indian Chambers of Commerce and Industry
CDSCO, Website
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