Legal Metrology

Packaging Rules for Medical Devices
Legal Metrology

Packaging Rules for Medical Devices

Packaging plays an important role between the trader and the consumer. A trader is provided with the advantage of advertisement through the package of the product and for the consumer is getting the benefit of having detailed information about the product. It has always been seen that more information provided on the product is equal to more customer to be attracted towards the product as the consumer is getting more knowledge with regards to the manufacturing of such product and get the awareness about the ingredients involved in making the product or any spare parts including its expiry date and also the way of using such product. Packaging is a wrapper or a cover or any type of covering material that is required to provide safeguard to the product from being exposed to sunlight or dust. Similarly, even medical devices registration has been covered under the packaging rules but in recent times, it has been observed that the medical device makers may be exempted from the packaging rules. The rules are applicable on multiple product packaging such as if you are packaging medicine such as Cenforce 150 Mg then you also have to understand them. In this article we are going to discuss the packaging rules and the exemption of medical devices which may happen for the makers of medical devices. What are the various laws on packaging? Various laws have been set up for the legal requirements of packaging in every field whether utilities, food, medical devices, or other products, etc. Under the ambit of the packaging of a product, Various laws have been regulated such as: Can Medical Device Makers Be Exempted From Packaging Rules? Medical devices Testing and Certification ELT Corporate is an Expert in Compliance The expert of legal metrology who actively participated in the standardization committee to gain unique technical expertise and actively stay informed of the latest changes to the compliance requirement. They will tell you about the process of compliance and why speaking to an expert is a better way to determine if your device is eligible for testing or require any other thing for the better compliances. ELT corporate does the comprehensive compliance testing of your medical electric equipment and the system ensures the safety, performance of your product, and quality. ELT corporate can help you to understand the specific standard requirement relevant to your product. The Advantage to Choosing ELT Corporate for Compliances ELT Corporate provides you with a single source provider while receiving all the documents from one place and saves your time and money to get your device into the market as fast as it can. It is one of the biggest corporations of compliance which provides the best way to every manufacturer and importer of medical devices. The laboratories are equipped with a wide range of active medical devices testing systems and also it is ready to serve you during the certification there are several other benefits of choosing ELT corporates such as: Why choose ELT corporate for the compliances? ELT corporate is an expert in medical devices, medical electric equipment specialty in market assist service, and also it serves you and the business around the world. It gained the confidence of its customer in these certification options and market knowledge by building the ideal certification package from the comprehensive list of services through a single source provider. It is a globally operational certification body with a wide range of testing facilities and certified staff serving an extensive portfolio of customers from every industry.

International Studies on Legal Metrology
Legal Metrology

International Studies on Legal Metrology

Legal Metrology plays an important role and it has various important factors which play the major role in the social and economic aspect of the country. It is just not about India only, it is about the entire world. Everyone is behind legal metrology and they cannot run their weights and measurement system without its help. In this article, we are going to discuss some international-level studies of legal metrology and assumptions on Legal Metrology of various authors and experts. We are going to discuss the history of legal metrology and how it works in various other sectors and what it all covers. As all are aware that wherever the weights and measures come, Legal Metrology is going to automatically cover that space. It plays a majorly important role and protects the rights of the consumer and its interest. Also on the other side of the coin it keeps the trade safer and secure for both the trader and the customer. Support  by Legal Metrology Various theories have been developed by different authors across the world on Legal Metrology however they have kept on changing with the change of time and era but it always has significance and a great impact on society and the world as a whole. Legal Metrology provides support and helps the economic system of the country, and it plays a major role in the social factor in the society of all countries. We are heading toward discussing some of the major studies on Legal Metrology and the economic benefits of legal metrology. Economic benefits of Legal Metrology History of Weights and Measures OIML Mutual Acceptance Arrangement Legal Metrology relations with regulatory Metrology

How Does Legal Metrology Help Society
Legal Metrology

How Does Legal Metrology Help Society?

Legal Metrology has developed over 5000 years ago with the development of civilizations, the required consistency of a wide range of measurements used in everyday life which includes the time and the calendar, weights and measures, distance, and area. The fundamental requirement to ensure consistency was that all measurements be driven from standards which are also known as traceability. Further in addition to moral prospects to ensure the integrity of the measurements were contained within the laws of Legal Metrology which creates trust and confidence in the measurement system in a significant component of the social capital of all societies and contributes to the maintenance of civil society. Legal Metrology Advantage to Society Having Legal Metrology is a great advantage to society as a whole and individuals. Legal Metrology always has an aim to protect the rights and interest of the consumer, not just that, it also provides various benefits and help to the Indian Economy, Society and various other sectors. Having a wider scope in the Indian Legal Metrology system is the prior responsibility of the Legal Metrology Act to provide the safeguard to the Interest of the public. In this article, we are going to discuss the several advantages of the act to society. Effects of Legal Metrology What Are The Areas Under Which The Legal Metrology System Works? The Legal Metrology system works almost in every area wherever the dealing is with the consumer and wherever the subject is about the measurement. Here we are going to tell you the different areas where the legal metrology system works are given below: In What Ways The Legal Metrology Helps Society?  Legal Metrology provides help to society in various ways out of which a few major points we are going to discuss below: Legal Metrology Helps in Improving Health Training Training programs in new and developing areas of Metrology provides an opportunity to model best practice in areas such as coordinate measurement machines and nanotechnologies. However, measurement competency is increased by delivering training programs in the followings: The Legal Metrology to Protect the Environment It helps in monitoring the environment which is a very important factor while taking any decision made by the government. Because we cannot ignore the impact of any decision on the environment. Decisions made by the government affecting the environment required the support of accurate traceable measurement which is provided by the legal metrology itself. These decisions impact how we live and include the followings: Help to a Doctor Reducing Deaths and Injuries   Legal Metrology can significantly reduce accidents by changing people’s behaviour, providing early warning signals and delivering effective enforcement of safety requirements. However public trust is an accurate measurement in road traffic enforcement that encourages respect for and compliance with traffic laws. Help in the Social Goals of the Government

Legal Metrology Department Functions for the Economy
Legal Metrology

Legal Metrology Department Functions for the Economy

The Legal Metrology department of India provides safeguard for the interest of the public, consumer, environment, and trade. The department is precise and very much careful about the fair-trade practice within the premises of India however the economy of India and the well-being of citizens rely on the rules and regulations of the government as well as the decisions taken by the government with respect to the industry that utilized the Legal Metrology for their day-to-day trades which takes place between the consumer and the trader in the country. In this article we are going to discuss the Legal Metrology functions for the economy and how Legal Metrology plays an important role and contributes to the Indian economic system. Functions of Legal Metrology for the Indian economy There are several roles that are played by the Indian Legal Metrology system and have been taken care of by the Legal Metrology officers with regard to the trade in the country and to increase the economic system of the country. Here we are going to discuss the functions of the legal metrology department which contributes a lot to the Indian economic system. Search functions are given below: Report of National Measurement System Review National measurement report which is also known as the national measurement system review aims at the discussion to improve understanding of economic rules in a national measurement system. (Read also: Legal Metrology for Measurement Infrastructure) However, the fundamental rationale for public funding and contribution to the metrologies for identifying the value of the economic and social benefit that it generates is the primary focus on the economics of innovation and measurements contribution to this. The measurement considered for identifying the benefits of measurement are given below:  The Economic Impact of the Peak Metrology Organization The Department of Trade and industry national measurement system policy unit reviewed the rationale of the economic benefit national measurement system; the review was limited to the economic impact of the peak Metrologic organization. The metrology employed was driven from endogenous growth theory and in particular the impact of technology however the impact of Metrology was driven from Metrology related patients as a percentage of total patients. Trade Metrology System Model scores each sector using six indicators The model is the course of each sector using six indicators are given below:  Terminative Levels of Intervention in Model There is a total of six cumulative levels of intervention which were defined in the model are as given below:

Importance of Legal Metrology in the Economic System of Country
Legal Metrology

Importance of Legal Metrology in the Economic System of Country

Legal Metrology has a wider scope and it plays an important role in almost every sector and even helps the government to take the various decisions. In this article we are going to discuss the importance of Legal Metrology and its contribution to the Indian Economic system, along with the relation between Indian Legal Metrology and Indian Economy. Relation between economics and legal metrology Benefits of Legal Metrology to the Economic System Legal metrology and the economic system of a country are parallel to each other as they support each other and protect the rights of the consumer and also keep the growth of the country in their mind. Legal metrology provides various benefits to the economic system of the country. Here we are going to tell you the relation between legal metrology and the economic system of the country as well as the benefits of legal metrology to the same. (Read also: Benefits of Legal Metrology Act) Prediction of the consumer by legal metrology Legal metrology specifically takes care of the measurement and the weights, and the goods packed by measure but generally replace number and simple measures as the basis of the transaction for a wide range of consumer commodities and products. The increase in the consistency of these measurements when adequately controlled has significantly reduced disputation and fraud on the other hand it increases the efficiency of the marketplace which has ultimately given the huge support to the economic system of the country while at the same time keeping the interest of the consumer at the safe side. Reduced Disputation and Transaction Cost Initially, the measurement was recognized as a provider of objective information and later on, when used in trade transactions where the measurement process lacked transparency there was an asymmetry of information between the trader providing the measurement and the trader accepting these measurements. There was considerable scope of uncertainty, disputation, transaction cost, and market efficiency. These transaction costs can result from concern about the accuracy of measurement for example short measures and the inconsistency of measurement and paying more than the quantity the consumer is getting. A typical example of trade measurement transaction that may lack transparency and are difficult to check are given below: Effective Stock Control The aggregate of trade measurement by individual business provides accurate and effective stock control to facilitate the ordering of new stock. This is a spillover benefit of the trade measurement system and the economic system of the country by the legal metrology. Legal Metrology for Commerce The metrological system ensures Fair Trading by eliminating the use of short measures to obtain commercial advantage over competitors in the marketplace. Legal metrology through the pattern approval and certification eliminates the manufacture and sale of many trade measuring instruments that are not fit for purpose and would not meet intentionally recognized standards. Legal metrology to protect the interests of the consumer Legal metrology aims to protect the interests of the consumer and the measurement and goods banned by measures has generally been replaced by numbers and simple measures. The basic transaction for a wide range of consumer commodities and products the increased consistency of measurement and adequately controlled has significantly reduced disputation fraud and increased the efficiency in the marketplace. Legal Metrology Helps in Control the Fraud  Legal metrology plays a great role in controlling fraud which provides a huge advantage to the economic system of the country. It also controlled fraud in the marketplace by estate inspection, and stock control by measurements can also provide effective fraud control for individual businesses. It has the pattern approval and certification which ensures that the design of the measuring instrument does not facilitate fraud and can stop the dealer from committing any kind of offence under the act. Legal Metrology for the Commodity Export State Meteorological System

Advantages Of Legal Metrology Act
Legal Metrology

What Are The Advantages Of Legal Metrology Act?

In this article we are going to talk about detailed advantages of Legal Metrology, will also discuss the benefits of Legal Metrology act Registration, what is the document procedure, and all about the LMPC Registration procedure. So, let’s begin with Legal Metrology, it is a lot related to weights and measures applied by all manufacturers and suppliers, and the dealers who deal in the Indian Legal Metrology system. There are a number of business operations which go through the weights and measurement for the federal performance of the business. To deal in the Indian Legal Metrology system it is mandatory for all the businesses to comply with the Legal Metrology Act. Implementation of Legal Metrology Act The Legal Metrology Act, 2009 was implemented with the effect from 1st April 2009. It contained the followings: Purpose and Advantages of Legal Metrology Act Benefits of Legal Metrology to the Businesses In our previous articles on legal metrology act we have discussed that legal metrology just not protects the rights of the consumer, but it also provides several benefits to the businesses including small vendors etc. Benefit Legal Metrology are given below: Documents required for Legal Metrology Registration Now we will talk about the documents required by different people dealing in the legal metrology registration. Requirement of the documents varies, if you are a manufacturer or repair or the dealer or the supplier. (Read also: Legal Metrology Transaction & Protection) Requirement of documents by Manufacturer In case of manufacturer the type of documents you would require, the list is given below: Mandatory declaration by Manufacturer List of Documents for Repairers List of documents for repairs in weight and measure you will be needing are given below: Documents Required by the Dealers List of documents which will be required by the dealer license is given below: Need of Registration under legal metrology act

Products Compliance with Legal Metrology Laws
Legal Metrology

Are Your Products in Compliance with Legal Metrology Laws?

The Legal Metrology (Package Commodity) Rule 2011 is applicable to all the products that come in the form of pre-packaged commodities. A pre-packaged commodity is defined under Section 2 subsection 1 of the Legal Metrology Act 2009. It clearly defines the pre-packaged commodities means any commodity without the purchaser being present in place in any package or nature whether sealed or not so that the product contained within the package has a predetermined quantity. Purpose of Legal Metrology Act  Mandatory Declaration Under the Indian Legal Metrology System  Your product complies with the legal metrology laws if all the LMPC declarations which are mandatory to comply as mentioned, has to be fulfilled by the manufacturer, importer, dealer of the commodity. All these mandatory declarations have been discussed below: (Read also: Regulatory Control of Measurement Under Legal Metrology) Legal Metrology Registration In view of obtaining the help with regard to the legal metrology registration the ELT legal metrology consultancy will help you out in the most reliable way by assisting you in filling in application for manufacturer and Packer registration from the legal metrology department for your pre-packaged commodities. Every manufacturer, Packer, and importer of the commodity is required to obtain the LMPC registration certificate from the legal metrology department as per the rule 27 of the legal metrology packaged commodities rules 2011. In the event of noncompliance, the penalty of offense under Legal Metrology on the defaulter shall increase up to INR 25000 as per the director and the company shall be levied. Clarification On Verification and Stamping of Weights and Measures  Legal Metrology department of consumer affairs regarding verification stamping of weights and measures used by the intermediary process in the industries during industrial production under the legal metrology 2009 the note was issued by the department on 6th May 2014 which states the following points: On Which Items the Legal Metrology Packaged Commodity Rules 2011 Is Not Applicable?  There are various items on which the legal metrology packaged commodities rules 2011 are not applicable and the list of such items has been given below: Is License Being Compulsory Under Legal Metrology At 2009?  Under section 23 of Legal Metrology Act, 2009 the license for manufacturer repairer dealer of any weights and measures is compulsory under Legal Metrology Act, no person shall make, manufacture, repair, sale any weights or measures unless he obtained a valid license by paying off the prescribed license fee as per the Legal Metrology act. Necessity Of Stamping and Verification Sometimes we have a question in our mind that what are the instances where stamping and verification is not necessary under the legal metrology in 2009. To which it is mandatory for all the people who are dealing in the Indian Legal Metrology system to know that the provision of legal metrology act relates to the verification and stamping of weights and measures shall not apply to any weights and measures under the following circumstances:

Legal Metrology Amended Rules
Legal Metrology

Legal Metrology Amended Rules 2022

The ministry of consumer affairs, food and public distribution vide its notification dated 20th March 2022 has notified the Legal Metrology (Packaged Commodities) Rules, 2022. It came into force on the 1ST of October 2022. However, the new amended rules further amend the legal metrology packaged commodity rules 2011. The ministry of consumer affairs had earlier as well vide notification dated 2nd November 2020 notified Legal Metrology Rules 2021 which were to be brought into the force from 1st April 2022. Key Features of Amended Rules  The key features of amended rules have been explained by us by the way of the chart given below so that every manufacturer, Packer, importer, and the companies will get proper clarification about the amended rules which will help them to comply with the rules and regulations of legal metrology act in order to stop themselves heading towards committing any kind of offense under legal metrology. S. NO RULE NUMBER PREVIOUS RULE AMENDMENTS 1. Rule 4 (1) – That the one or more packages intended for retail sale are grouped together for being sold as a retail package or promotional offer, and every package of the group shall complies with the provision of rule 6. 2. Rule 5 Rule 5 provided for the specific commodities to be packed and sold in recommended standard packages. The mentioned and said rule has been omitted. 3. Rule 6 (1) (d) earlier rule 6 (1) (d) under which the month and year in which the commodity was manufactured or prepared or imported shall be mentioned in the package. As per the new rules the words such as “or pre-packed or imported” have been omitted. 4. Rule 6 (1) (e) This rule deals with the declaration of the retail sale price on the package which earlier the rule stated that the package shall clearly indicate the MRP and price in rupees and the Paisa shall be rounded off to the nearest rupee or 50 Paisa. The declaration of retail sale on the packaging shall be provided in the Indian currency as per the new rule under legal metrology. 5. Rule 6 (11) A new provision was inserted where the legal metrology amendment rule 2021 as per which the unit price needs to be declared on each package along with the MRP in Indian Rs. The New Rules state as follows: The unit sale price in rupees rounded off to the nearest two decimal places. Further, it shall be declared on every pre-packaged commodity in the following manner: Per gram where net quantity is less than one kilogram, and Per kilogram where net quantity is more than one kilogram; Per number or unit if any item is sold by number or unit. Per centimeter where net length is less than one meter, and Meter where net length is more than one meter; Per milliliter where net volume is less than one liter, and Per liter where net volume is more than one liter. However, the package contains alcoholic beverages or spirituous. Further, the state excise law and the rules made thereunder shall be applicable according to each different state in which such product is manufactured. Further, the declaration of the unit sale price is not required for the prepackaged commodity in which the retail sale price is equal to the unit sale price. 6. Rule 33 Power to relax The said rule has been omitted. 7. II schedule Commodities to be packed in a specific quantity The said schedule has been omitted. Legal Metrology General Amendment Rules 2022  Department of consumer affairs, Government of India vide its notification has notified Legal Metrology (General Amendment) Rule, 2022 dated 4th October 2022 according to which the following amendments have to be taken place: “any company may by order in writing authorized any of its director to exercise all such powers and to take all such steps as may be necessary or expedient to prevent the Commission by the company of any offense under this act and may give notice to the director or the concerned controller or any legal metrology officer authorized in this behalf by a such controller (hereinafter in this section referred to as the authorized officer) in such form and in such manner as may be prescribed that it has nominated such director as the person responsible along with the written consent of such director for being so nominated”  (Read also: Importance of Declaration on Packages) “Provided that where a company has different establishment or branch or different unit in any establishment or branch, an officer who has the authority and responsibility for planning, directing the controlling the activities of the establishment or branch or different unit may be nominated under subsection two of section 49 to be in charge of and be responsible for the conduct of business alpha establishment branch or unit thereof.”

Importance of Director Nomination Under Legal Metrology
Legal Metrology

Importance of Director Nomination Under Legal Metrology

Legal Metrology is one of the most frequently misunderstood by the company resulting in heavy fines. All the acts and complaints are very simple. There is a lot of misunderstanding about dictation which needs heavy petting about the current compliance and works under the legal metrology. In this article, we will discuss the director’s nomination under the legal metrology act. Director nomination under Legal Metrology Act From the above-mentioned examples, you know why nominating a director is important. Appointment Procedure of Director Here we are going to discuss the requirements of the appointment procedure for the director and how to cancel the appointment of the director. There are legal metrology laws on marketplace E-Commerce Entities. The requirement and Procedure to appoint the director is given below: Legal Metrology for Accuracy in Weights & Measures Legal Metrology refers to signs of measurement. Legal Metrology is a branch of Metrology that deals in the followings: Facts about Legal Metrology Legal Metrology Rules by Government However, to ensure uniform enforcement of laws relating to legal metrology in the country, the government has enacted the following rules In India, we have around 7-8 rules that follow the Legal Metrology Act, 2009 which plays an important role in the Indian legal metrology system.

Models Submission of Weights & Measures
Legal Metrology

Legal Metrology: Models Submissions of Weights & Measures

Every person who submits any model of weights or measures or weighing or measuring instrument for approval shall deposit the credit to the Recognized Laboratory with a prescribed fee as per the rule 19 of the act. While submitting the documents referred under the act shall be sent by the director to the recognized laboratory, which carries out the test for the approval of the model to enable the laboratory to ascertain whether search documents conform to the details of the results of the test carried out for the approval of that model. Offence of weights and measures is punishable under IPC. Testing of Weights & Measures in Recognized Laboratory Central Government and Recognized Laboratories for Weights & Measures The central government and the recognized laboratory shall not be responsible for any loss or damage that the model may sustain during examination and testing. Forfeiture of Model by the Central Government Where any model submitted to the recognized laboratory for approval is not removed by the applicant within six months from the date on which a certificate of approval was granted, or if used concerning such model, such model shall be forfeited by the central government and the government shall dispose of the model in such a manner as it may deem fit. The Central Government can also stop the Import and Export of weights and measures in case of offence committed. Approver of Model by the Director of Laboratory The director may if he is satisfied that the test for the approval of any model is likely to take more than three months and on receipt of satisfactory preliminary test report from the laboratory issue subject to such condition as a manufacturer to manufacture at his own risk, the weight or measures concerning which the model has been submitted for approval. (Read also: Legal Metrology: Delegation Power of Government) Withdrawal of the Model Approval Certificate The manufacture, distribution, or sale of the instruments shall be discontinued immediately when the professional model approval certificate has been withdrawn by the director. Further that in case the tested model does not meet the requirement of the model approval test, in such a situation all the instruments covered by the provisional certificate and sold in the market shall be withdrawn with immediate effect at the manufacturer’s cost. Test for the Approval of the Model The test needed for the assessment of the fitness or otherwise for a model submitted for approval shall be carried out under the normal conditions for use whether actual or estimated or the weights or measures shall be made with a view to the following: Contents of Certificate of Approval under Legal Metrology The certificate of approval shall also contain the following contents or information given below: Testing Fee for a Model of Weights or Measures The fees for testing of a model of weights or measures to be deposited in a manner that the applicant shall while making an application under the act should deposit fees in the form of a demand draft drawn in favour of the laboratory, or through online payment towards testing charges of the laboratory in the following manner given below:

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