Service Details:
Type Of Industry | Service |
Service Location/City | Maharashtra |
Import / Export Location | Pan India |
License (Medical Devices and In-Vitro Medical Devices) – Indian Manufacturer
For Manufacturer of medical devices following form available for application and approval of licenses.
1. Application for Grant of Licence to Manufacture for Sale and Distribution of Class A or Class B medical device in MD-3 and Licence to Manufacture for Sale or for Distribution of Class A or Class B Medical Device in MD-5.
2. Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device in MD-4 and Loan Licence to Manufacture for Sale or for Distribution of Class A or Class B medical device in MD-6.
3. Application for Grant of Licence to Manufacture for Sale or for Distribution of Class C or Class D in MD-7 and Licence to Manufacture for Sale or for Distribution of Class C or Class D in MD-9.
4. Application for Grant of Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D in MD-8 and Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D medical device in MD-10.
5. Application for licence to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training in MD-12 and Licence to Manufacture Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training in MD-13.
6. 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.
7.
Consultancy Charges will be provide separately based on products.
Procedure for License to Manufacturer of Medical Devices (Indian Manufacturer - 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 Manufacturer license as per application form.
Timeline of Process
After application to CDSCO – 4 to 6 Months
Service Details:
Registration Service Type | Medical device Import/CDSCO |
Type Of Service Provider | Application,Advisory,Documentation and Liaison with dept. |
Import / Export Location | global |
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.
Consultancy Charges will be provide separately based on products.
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.
Timeline of Process
After application to CDSCO – 1-2 Months.
Service Details:
Location/City | Global |
Service Charges | Application , Documentation, Advisory and laison with dept. |
Type Of Industry | Food |
Type of Certification | New Certification |
Type Of Service Provider | Consulting Firm |
Service Details:
Type Of Industry | Event Industry |
Mode Of Report | Offline |
Location/City | Pan India |
Type of Certification | New Certification |
Type Of Service Provider | Consulting Firm |
As a statutory authority, PESO is entrusted with the responsibilities under the Explosives Act, 1884; Petroleum Act, 1934; Inflammable Substances Act, 1952, Environment (Protection Act), 1986 and the following rules framed there under:-
Petroleum & Explosives Safety Organisation (PESO), Nagpur is the nodal Organization to look after safety requirements in manufacture, storage, transport and use of explosives and petroleum. The Organization is headed by Chief Controller of Explosives with its headquarter located at Nagpur (Maharashtra). It has five Circle Offices located in Kolkata, Mumbai, Chennai, Faridabad and Agra and 18 Sub-circles Offices in the country. It has a Departmental Testing Station (DTS) at Gondkhairy, Nagpur where tests on explosives, safety fittings of road tanker, cylinders/ containers are carried out. Fireworks Research and Development Centre (FRDC) at Sivakasi, Tamil Nadu for testing and development of ecofriendly fireworks has been set up by PESO to ensure safety and security of public and property from fire and explosion. Please see PESO’s website PESO for more details
EXPLOSIVES ACT, 1884
Explosives Rules, 2008
Ammonium Nitrate Rules, 2012
Gas Cylinders Rules, 2016
Static and Mobile Pressure Vessels (Unfired) Rules, 2016
Notification No. GSR 625/(E) dated 07.08.1983 regarding Acetylene Generator.
PETROLEUM ACT, 1934
Petroleum Rules, 2002
Calcium Carbide Rules, 1987
Cinematography Film Rules, 1948 (These rules have become obsolete and are to be repealed).
Major Activities and Functions of PESO:
i) To approve layout and construction plans/ licence for explosives manufacturing units and other installations;
ii) To scrutinize returns of purchase, use and sale of explosives;
iii) To regulate and implement safety regulation norms in over 2.56 lakh licensed premises/units used for manufacture, storage, transport and handling of hazardous substances;
iv) To advise Port, Airport and Railway authorities in respect of transportation of explosives & other dangerous substance whenever asked for;
v) To impart training to police personnel, security and other officers in safe handling of explosives.
Modernization and Computerization: The following steps have been taken to make the functioning of the organization more efficient, transparent and user friendly:-
All Explosives manufacturers including SMEs are submitting their explosive production data online on day to day basis, since 1st July, 2010 and submission of online returns is compulsory for Explosives Magazine licence holders. Under the Explosives Rules, 2008, the existing ERS (Explosives Return System) has been enhanced to compulsorily generate RE-11 (indent) on the part of purchaser. Preparation of RE-12 also goes through the checks and balances provided in the system to adhere to various provisions of the Explosives Rules. On actual receipt of explosives, the consignee accepts the explosives online in the ERS. Thus, features like knowing the real time stock have further enhanced the ERS and streamlined transactions of explosives to a greater extent. Introduction of pass for use (RE-13) is another initiative launched for users of explosives in mines and other sites to streamline the usage and maintenance of records. This initiative will help curb misuse and mis-appropriation of explosives and will also bring accountability. Sites of use of explosives with names of blasters will also be captured in the database.
The Marine Products Export Development Authority (MPEDA) was set up by an act of Parliament during 1972. The erstwhile Marine Products Export Promotion Council established by the Government of India in September 1961 was converged in to MPEDA on 24th August 1972. MPEDA is given the mandate to promote the marine products industry with special reference to exports from the country. It is envisaged that this organisation would take all actions to develop and augment the resources required for promoting the exports of “all varieties of fishery products known commercially as shrimp, prawn, lobster, crab, fish, shell-fish, other aquatic animals or plants or part thereof and any other products which the authority may, by notification in the Gazette of India, declare to be marine products for the purposes of (the) Act”. The Act empowers MPEDA to regulate exports of marine products and take all measures required for ensuring sustained, quality seafood exports from the country. MPEDA is given the authority to prescribe for itself any matters which the future might require for protecting and augmenting the seafood exports from the country. It is also empowered to carry out inspection of marine products, its raw material, fixing standards, specifications, and training as well as take all necessary steps for marketing the seafood overseas.
MPEDA is the nodal agency for the holistic development of seafood industry in India to realise its full export potential as a nodal agency. Based on the recommendations of MPEDA, Government of India notified new standards for fishing vessels, storage premises, processing plants and conveyances. MPEDA’s focus is mainly on Market Promotion, Capture Fisheries, Culture Fisheries, Processing Infrastructure & Value addition, Quality Control, Research and Development.
Functions of MPEDA in brief:Service Details:
Type of Certification | New Certification |
Type Of Industry | R & D/Pharma/ Electronic/ Software |
Type Of Service Provider | Consulting Firm |
The aim of this Technical Specification is to guide organizations to introduce, develop, and maintain a framework for systematic innovation management practices, an Innovation Management System (IMS).
Establishing such a management system would allow organizations to become more innovative and to achieve more success with their product, service, process, organizational design and business model innovations.
Benefit of implementing TS 16555 “Innovation Management System”?Enhances growth, revenues and profit from innovations;
Brings fresh thinking and new value to the organization;
Proactively captures value from better understanding of future market needs and possibilities;
Helps identify and mitigate risks;
Taps into the collective creativity and intelligence of the organization;
Captures value from the collaboration with partners for innovation;
Motivates employee involvement in the organization and fosters teamwork and collaboration.
Implementation phases but not limited to :
Identify needs and expectations of the organization.
Hold Awareness training sessions.
Create management system including, “Policies, Manuals, Processes, Templates, etc.) .
Integrate new system with other active management systems within the organization.
Support in implementation of all standard requirements.
Hold certified Training Course.
Conduct Internal audit and follow up closing Nonconformities.
Prepare for external audit.