Fast and Reliable Medical Device Regulatory
MN Medical Device Regulatory Services
Our customized and specialized device regulatory services provide a satisfactory regulatory compliance service to our customers that, is in complete synchronization with their product launch and go market strategy. Our timelines are fast enough and agile enough to accommodate your forthcoming product launch. At the same time we ensure that all bottlenecks and impending formalities and documentation is taken care off well in advance in the documents workflow at our end.
From the initial stage of knowing about our valued customers and their proposed medical device for regulation till the grant of the final product approval; we follow a very systematic in-house process flow. We offer customized consulting through our In-house formats and templates suiting the specific needs of a particular customer. These templates, formats and forms sheets are quite unique to our approach and this sets our regulatory services apart from the rest of our competition.
Our Device Regulatory Services Include the following workflow;
a. a. Processing your requirement with due diligence
b. Finalizing all the requisite documents and mandatory information and finally Submission of applications
c. Regular review of approved devices and forthcoming up-gradations
d. Post Regulation feedback to our valued customers
Our Regulatory Services Portfolio consists of;
Regulatory services in the areas of API’s, Formulations, Vaccines, Biotechnology products, Medical Devices, In-vitro Diagnostic Kits, Cosmetics and Food items:
1. Site and Product Registration for Pharmaceuticals, Medical Devices, IVD’s & Biologicals
As per Drugs & Cosmetics Act & Rules the manufacturing site and the products intended to be imported from the sites need to be registered and our team have experts to handle such requirements of the foreign manufacturer and Indian Importers.
2. Cosmetic Products Registrations
As per GSR 426 (E), the cosmetics need registration in India prior to their import.
3. New Product Approval for Pharmaceuticals, Medical Devices & Biologicals
As per Rule 122 of Drugs & Cosmetics Rules the Drugs/Devices new in India or within 4 years of their introduction need an approval under this rule as an application in Form 44.
4. Authorized India Representative
Indian Drugs & Cosmetics Act defines the “Authorized India Representative” as” Indian Agent”, who can obtain drug and cosmetic Registration on behalf of foreign manufacturers.
5. AERB Approval
Atomic Energy Regulatory Board issues approval for the radiation associated devices like X-Ray machines.
6. PNDT Approval
Pre-Natal Diagnostic Technique Act deals with the approval of Ultra-Sound machines.
7. Dossier Development & Technical Files
Our team is blend of experts having wide experience in Medical Writing of Dossiers and Technical files.
8. Free Sale Certificate
The FSC is issued by the State Licensing Authority to the manufacturers intending to export their products covered under Drugs & Cosmetics Act and our expertise provides a regulatory edge to the manufacturers for same.
9. NOC’s for Surgical
The Devices on the border line, wherein the CDSCO is the Apex Authority to define the devices to be regulated and we assist in filing such applications with the CDSCO.
10. CT NOC
Clinical trial No Objection Certificates are to be obtained for the New Drugs/Devices/Investigational Drugs/devices/trials for new indications, dosage forms etc.
11. FSSAI Registrations
We assist the FBO’s to obtain their Form B and NOC’s for New Food item/ingredient approval.
- MEDICA13-16 Nov 2017, Germany
- IOACON 26-31 Dec 2017, Indore (India)
- NSICON 30-Nov-3rd Dec 2017, Nagpur (India)
- Arab Health 29th Jan-1st Feb 2018, Dubai