Packaging Rules for Medical Devices

Packaging Rules for Medical Devices

Introduction

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. 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:

  1. Bureau of Indian standards,
  2. The legal metrology Act 2009,
  3. Packaged commodity rules 2011,
  4. Food safety and standard authority of India Act 2006,
  5. Food safety and standard authority of India Rules, 2011.

Can Medical Device Makers Be Exempted From Packaging Rules?

  1. The manufacturers of medical devices are likely to be exempted from the Legal Metrology (Packaged Commodity) Rules, 2011. Legal metrology packaged commodity rules 2011 mandates that every package must have the address, e-mail ID, telephone number, name of the manufacturer of the device or the office address, and e-mail ID which the consumer can contact to make a complaint.
  2. The department of pharmaceuticals has reconstituted the national medical device promotion council and held a meeting in September 2022. In that meeting, the discussion on the exemption of licensed manufacturers of medical devices from legal metrology packaged commodity rules 2011 took place. You can also check the Legal Metrology for covid 19 related items.
  3. Patient safety should be paramount and the move of doing away with the packaging rules will only be the benefit importer, said Mr. Rajnath the Forum Coordinator. Further, he added that many importers have not been implementing the packaging rules and the provision of the legal metrology act and the Consumer Protection Act as the enforcement mechanism has been weak on them while being stringent on Indian manufacturers.
  4. Whenever any Indian manufacturer exports to Europe, the United State, middle States we respect the laws of the land but the importers who don’t wish to regulate seek exemption from the application of these laws and rules under the garb of ease of doing business, Mr. Rajnath forum coordinator added in his words.
  5. Further Mr. Rajnath added that the department of consumer affairs needs to enforce the laws and rules book equality and provide a level playing field and not be misled by any importer whosoever imports the medical devices in the premises or the jurisdiction of the country.
  6. The patient safety aspect of the drugs act is complementary to the consumer protection aspect of the legal metrology act.
  7. However, the reconstitution comes after the department of promotion of industry and internal trade under the Ministry of Commerce and industry which is heading the council from its exemption and decided to hand over the onus.
  8. The meeting was attended by the representative of the industry association and government officials to discuss whether the medical device makers may be exempted from the packaging rules or not and soon the decision will be taken on the same.

Medical devices Testing and Certification

  1. It is necessary to complete the labelling compliance evaluation, testing, and device approval before being placed on the market while dealing with the Indian legal metrology system.
  2. The manufacturer or importer of the medical device can even consult the expert for the desired market, in addition to the framework in which the product can be designed and manufactured will be evaluated and harmonised standards recognized worldwide with several logicist deviations in the key market.
  3. The compliance standard might be costly to the manufacturer, specifically in the areas of product redesign, device approval, compliance testing, and certificate turnaround time.
  4. The process of testing and certification of fulfilling the current standard can be quite complex and multiphase task due to which the mandate collateral particular performance standard specific to devise type can be quite complex to the manufacturer or the importer of the medical device however it is required for the relevant certificate to obtain while making the import in the Indian premises.
  5. The manufacturer’s intent destination market determines whether he requires the certificate, comprehensive evaluation report, or both.
  6. Documentation complaints risk management practice must be clear the product lifecycle and device labelling in conjunction with technical documentation and device samples the medical electrical equipment and system are tested according to the established electromagnetic Patty ability as well as the electrical and environmental safety standards.

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:

  1. It provides you with upfront pricing.
  2. ELT Corporate provides the customised service packaged according to the needs of the customer.
  3. It saves time and money and provides effective service to its clients.
  4. It provides a wider scope of comprehensive testing services.
  5. It can help you out in these state of art laboratories around the world for reliable and faster results.

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.

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