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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.

Sr. No. Attested copies of following Documents be submitted A) Identity Proof (Any One) i) PAN Card ii) Aadhar Card iii) Passport iv) Driving Licence v) Election ID Card B) Proof of Possession of premises (Any one) i) Rent Receipt ii) Commercial Photopass iii) Registered Leave & Licence Agreement iv) Lease Deed v) PR card vi) Allotment Letter vii) Maintenance Receipt issued by the C.H.S. viii) Electricity Bill C) Proof of Business Entity (If applicable) i) Copy of Partnership Deed ii) Copy of Memorandum of Association iii) Certificate of Incorporation under the Companies Act iv) Certificate issued by the Charity Commissioner under the Registration of Societies Act and Mumbai pubic Trust Act D) No Hoarding is in Compulsory Open Space, Certificate to be brought from Executive Engineer Building Proposal.

The Health Department is an administrative department of MCGM that issues various licenses in consultation with an advice from other technical advisory departments like, Fire Brigade, Health, Engineering, Estate, etc. In view of this it is necessary for Establishments to take necessary license from Heath department before starting manufacturing, storage or trade of any commodity/activity. The application must be received from the establishment three months prior to starting the activity. Commodities/ activities including eating house, restaurants, manufacturing drugs, medical shops, manufacturing and/or sale of milk and milk products, condiments, aerated water, ice factories, etc. fall under this license category.

List of mandatory documents required from applicant for acquiring fire safety compliance of new trade under health department u/s 394 of mmc act 1) plan showing layout (building/premises) location of main entrance / exit / staircase / lifts / fire lift as per approved plan by competent authority. 2) plan from architect for trade premises under reference with following details marked a) location of access road (name of road & its width) for the premises. B) area of the premises in sq. Mtrs. C) maximum number of person including staff calculated as per occupant load factor mentioned in nbc/dcr d) location & width of all entrances, exits& internal passages. E) location of loft / mezzanine floor along with staircase for loft / mezzanine floor as certified by competent authority. F) location of segrees, burner, cylinder, gas cabin &/or proposed machinery layout plan, storage area, used for trade activity. G) distance between segree, burner, bhatti. H) location of main electrical switch board i) location of fire resistant door. J) location of l. P. G. / p. N. G. Installation and supply pipe line. K) location of l. P. G. /p. N. G. Leak detector. L) location of main emergency shut off / isolating valve of p. N. G. / l. P. G. Installation. M) location of fire-fighting equipment / installation including sprinkler / detector, if already stipulated as per c. F. O. N. O. C. 3) test certificate regarding electric audit for electrical fittings/fixtures installed in the premises as per electricity act & rules from govt. Approved electrical inspector. 4) certificate in form-a from licensed agency for fire resistance door installed in the premises. 5) as per sec-3(3);rule 4(2) of maharashtra fire prevention & life safety measures act-2006, form-a &/or form-b certificate (as the case may be) from authorized licensed agency regarding fire-fighting & fire-protection system/equipment stipulated/installed on the premises. (applicable in case of fire system installation) 6) in case where only fire extinguisher are stipulated (with bis, e. N. Standards or other equivalent standards) validity certificate shall be provided. 7) in case l. P. G. Cabin is proposed, the authenticity of it’s location certified by a. E. (b&f) shall be produced. (applicable in case of more than 2 cylinder) 8) undertaking cum indemnity bond on stamp paper of rs. 500/- as displayed on portal.

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FOOD IMPORTS/ FSSAI We are your partners for Import of Food Products in India. From registration with Food Safety and Standards Authority of India (FSSAI), expectations and guidelines, Labelling Compliance, Legal Metrology compliance, FSSAI customs clearance at time of Import, etc; we ensure your import of food products are hurdle-free, scheduled, effective and economical.

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ISO 20121 is a management system standard that has been designed to help organisations in the events industry improve the sustainability of their event related activities, products and services.  ISO 20121 is based on the earlier British Standard called ‘BS 8901 Specification for a Sustainability Management System for Events’ which was first developed in 2007. Due to the high level interest in BS 8901, it was decided to create an international version of the standard to coincide with the London 2012 Olympics. In simple terms, ISO 20121 describes the building blocks of a management system that will help any event related organisation to:

• Continue to be financially successful
• Become more socially responsible
• Reduce its environmental footprint

ISO 20121 applies to all types and sizes of organisation involved in the events industry – from caterers, lighting and sound engineers, security companies, stage builders and venues to independent event organisers and corporate and public sector event teams.  Organisations that successfully implement the standard will be able to seek independent recognition of their achievement through a process called ‘Certification’.  
Six important points to understand about the ISO 20121 Standard

1.     ISO 20121 is a “specification”The standard specifies the management system elements that an organisation has to have in place. All the elements described in the standard must be in place prior to the organisation being able to claim compliance with the standard.   2.     ISO 20121 is not a checklistThe standard is not a checklist but is a more complex document that describes the elements of a management system that an organisation has to have in place. 3.     ISO 20121 is difficult to understandUnfortunately, international standards such as ISO 20121 are written in a way that is often unintelligible to many people. Consequently, you may need help in interpreting the requirements. Our ISO 20121 Team has developed a Guide to ISO 20121 that provides a plain and simple step by step roadmap on how to meet the requirements of the standard. 4.     ISO 20121 is about the management systemThe standard applies to the management system used by organisations in delivering their event related activities, products and services. It is the management system operated by the organisation that is compliant with ISO20121, not the event.  (Note: a management system is the set of interrelated or interacting elements that are used to establish policies and objectives, and the processes to achieve those objectives.)
 5.     ISO 20121 may require the adoption of new practicesAll organisations have a management system of some kind otherwise they would not be in business, it just might not be written down or thought of in the terms used within the standard. In our experience, most organisations are already doing up to 70% of what the standard requires. Hence achieving ISO 20121 may not require any radical change but is likely to require the adoption of new practices. 6.     ISO 20121 does not set performance requirementsThe standard does not specify which sustainability issues to manage or what performance levels to achieve. What the standard requires is that an organisation has in place a transparent process through which it systematically evaluates the issues relevant to its operations and sets its own objectives and targets for improvement.

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

• Official twitter handle of the PESO Nagpur

EXPLOSIVES ACT, 1884

1. Explosives Rules, 2008

2. Ammonium Nitrate Rules, 2012

3. Gas Cylinders Rules, 2016

4. Static and Mobile Pressure Vessels (Unfired) Rules, 2016

5. Notification No. GSR 625/(E) dated 07.08.1983 regarding Acetylene Generator.

PETROLEUM ACT, 1934

1. Petroleum Rules, 2002

2. Calcium Carbide Rules, 1987

3. 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.

 

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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

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:

• Registration of infrastructural facilities for seafood export trade.
• Collection and dissemination of trade information.
• Promotion of Indian marine products in overseas markets.
• Implementation of schemes vital to the industry by extending assistance for infrastructure development for better preservation and modernised processing following quality regime.
• Promotion of aquaculture for augmenting export production through hatchery development, new farm development, diversification of species and up gradation of technology
• Promotion of deep-sea fishing projects through test fishing, joint ventures and up gradation & installation of equipments to increase the efficiency of fishing.
• Market promotional activities and publicity.
• To carry out inspection of marine products, its raw material, fixing standards and specifications, training, regulating as well as to take all necessary steps for maintaining the quality of seafood that are marketed overseas.
• Impart trainings to fishermen, fish processing workers, aquaculture farmers and other stake holders in the respective fields related to fisheries.
• Conduct research and development for the aquaculture of aquatic species having export potential through Rajiv Gandhi Centre for Aquaculture (RGCA).
• Conduct extension and awareness activities, trainings etc through Network for Fish Quality Management and Sustainable Fishing (NETFISH) & National Centre for Sustainable Aquaculture (NaCSA).
• To prescribe for itself any matters required for protecting and augmenting the seafood exports from the country in the future.

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What is TS 16555 “Innovation Management System”?

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”?

1. Enhances growth, revenues and profit from innovations;

2. Brings fresh thinking and new value to the organization;

3. Proactively captures value from better understanding of future market needs and possibilities;

4. Helps identify and mitigate risks;

5. Taps into the collective creativity and intelligence of the organization;

6. Captures value from the collaboration with partners for innovation;

7. Motivates employee involvement in the organization and fosters teamwork and collaboration.                                                                                                                   

   Implementation phases but not limited to :
   1. >Conduct Gap analysis and evaluate current Situation according to the standard requirements.

       

   2. Identify needs and expectations of the organization.

   3. Hold Awareness training sessions.

   4. Create management system including, “Policies, Manuals, Processes, Templates, etc.) .

   5. Integrate new system with other active management systems within the organization.

   6. Support in implementation of all standard requirements.

   7. Hold certified Training Course.

   8. Conduct Internal audit and follow up closing Nonconformities.

   9. Prepare for external audit.