Legal Meteorology Requirements, Medical Devices, India

Legal Metrology Compliance

Are you a manufacturer or importer of Medical Devices and In-Vitro Diagnostic (IVD) devices? If so, it’s important to understand that you cannot manufacture, sell, or distribute these products without adhering to the regulations of the targeted country. The primary goal of these regulations is to ensure that medical devices and IVDs are safe for their intended users, significantly impacting public health. Consequently, it is the duty of the manufacturer or importer to comply with these regulations. For instance, if a manufacturer or importer aims to introduce their products in the Indian market, they must engage with the Central Drugs Standard Control Organization (CDSCO), India’s regulatory authority, to get their Import license in the form of an MD-15.

In addition to the MD-15, compliance with other regulations such as those governing Legal Metrology and Plastic Waste Management is also required. The use of weights and measures in medical devices, as well as packaging, is regulated to ensure fair trade and consumer protection, as mandated by the Legal Metrology Act of 2011. For medical devices, accurate labeling and packaging are essential for compliance and safety. Additionally, the Essential Commodities Act and Drugs Price Control Order (DPCO) regulate the production, supply, and pricing of these devices affecting the availability and affordability of medical devices. The Legal Metrology Division issued a notification in 2023 extending the Legal Metrology (Packaged Commodities) Rules, 2011, to include medical devices. Since February 2020, medical devices have transitioned from DPCO regulation to the Essential Commodities Act.

A Legal Metrology Registration Certificate, also known as a Legal Metrology Packaged Commodity(LMPC) Certificate, is required under the Legal Metrology Act of 2009 and the Legal Metrology(Packaged Commodities) Rules of 2011. This certificate is essential for the sale, distribution, or manufacture of medical devices and IVDs, ensuring fair trade practices and protecting consumer rights.

Essential Packaging Information

According to the notification issued by the Ministry of Consumer Affairs on July 14th, titled Legal Metrology (Packaged Commodities) (Second Amendment) 2022, marketers are allowed to provide additional information through a QR code. However, critical information must be prominently displayed on the package for consumers.

In sub-rule (1), clause (a), before Explanation I, the following provision must be included: For electronic products manufactured, packed, or imported after July 15th, 2022, the packaging must display the name of the manufacturer, packer, or importer for one year. Additionally, it should instruct consumers to scan the QR code for any other information not provided on the package.
Clause (b): For electronic products manufactured, packed, or imported after July 15th, 2022, consumers must be able to scan a QR code to access information such as the common or generic name, number, and quantity if the package contains multiple products and this information is not available on the package.
Clause (f): For electronic products manufactured, packed, or imported after July 15th, 2022, the packaging must have a QR code for one year that provides information on the size and dimensions of the product if these details are not stated on the package.
Sub-rule (2): For electronic products manufactured, packed, or imported after July 15, 2022, the packaging must include a QR code for one year that allows consumers to access the manufacturer’s mobile number and email address if this information is not displayed on the package.

Registration and Certification Process

Entities involved in manufacturing, importing, or dealing with packaged commodities must obtain the required certification. LMPC (Legal Metrology Packaged Commodities) Certificate to ensure compliance with the Legal Metrology (Packaged Commodities) Rules, 2011.This process requires submitting an application with business registration details, GST registration, and packaging labels to the Legal Metrology Department. After inspection and verification, the certificate is issued, allowing legal packaging and sale. Regular compliance checks ensure adherence to regulations, promoting fair trade and consumer Protection. The following documents are required to meet the LMPC Certificate requirements of the authorized person Company’s behalf for the license:

Photographs
Identity and address proofs
Proof of date of birth
Proof of possession of premises
Business registration documents
GST registration
PAN card
Affidavits of compliance and non-conviction
Specific certificates depending on the entity type:
- Model Approval Certificate (for manufacturers)
- Pollution Control Board NOC (for manufacturers)

Registration Procedure

The registration involves several steps. It begins with applying using the relevant forms (LM-1 for manufacturers, LD-1 for dealers, LR-1 for repairers) to the District Nodal Officer, followed by a thorough inspection of premises and documents by a Local Inspector. Capability assessments are conducted, reports are prepared, and recommendations are made to the Controller. After addressing any objections and paying the license fee of Rs. 500, the license is granted. Failing to comply with these regulations comes with penalties, including a fine of Rs. 4,000 for not registering, fines ranging from Rs. 2,000 to Rs. 50,000 for incorrect declarations or non-declaration, and penalties up to Rs. 1,00,000 or imprisonment for repeated offenses.

Legal Metrology Packaging & Labeling Law

Understanding the Legal Metrology Packaging & Labeling Law is also essential. This law defines the rules for packaging, labeling, and selling products, ensuring customers receive accurate information about product quality, quantity, and safety.Legal Metrology Package Labeling Laws require pre-packed goods to display the name and address of the importer, packer, or manufacturer, the generic or common name of the product, the net quantity in standard units, the retail price, and dimensions if applicable.

Products exempted from LMPC

An LMPC certificate is mandatory for manufacturers and importers of all medical devices or IVDs, except for certain exemptions: (1) Medical devices have a total weight or volume of 10 grams or less, or IVDs have a volume of 10 milliliters or less and (2) Packages contain formulations governed by the Drugs (Price Control) Order of 1995.

Additionally, Chapter 2 of the Legal Metrology Act, which covers regulations for packages meant for retail sale, does not apply to: (1) Medical devices exceeding 25 kg in weight or IVDs exceeding 25 liters in volume, with the exception of cement and fertilizers packaged in quantities up to 50 kg and (2) Packaged commodities are meant for industrial consumers (those who buy the goods directly from the manufacturer for use in that industry) or institutional consumers (service institutions such as airways, railways, hotels, and hospitals).

Streamlining Compliance with Morulaa

Morulaa provides specialized services to simplify this process for medical device manufacturers and importers. Morulaa offers guidance on LMPC Certificate requirements and procedures, documentation assistance for preparing and submitting necessary documents, compliance support to ensure adherence to all legal requirements, and pre-audit services to conduct pre-audit checks ensuring regulatory readiness. This streamlining can help in obtaining crucial certifications like MD-14 and SUGAM, facilitating smoother interactions with CDSCO. Integrating these services ensures that medical devices and IVDs are efficiently registered and compliant with all necessary regulations, including those set forth by CDSCO. To know more about how we can support you, Click Here or email us on [email protected].