Tag: Manufacturers

Notification

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Guidelines on Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022

The Central Consumer Protection authority (CCPA) under the Department of Consumer Affairs has notified ‘Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022’ with an objective to curb misleading advertisements and protect the consumers, who may be exploited or affected by such advertisements.

The guidelines seek to ensure that consumers are not being fooled with unsubstantiated claims, exaggerated promises, misinformation and false claims. Such advertisements violates various rights of consumers such as right to be informed, right to choose and right to be safeguarded against potentially unsafe products and services

Keeping in view the sensitiveness and vulnerability of children and severe impact advertisements make on the younger minds, several preemptive provisions have been laid down on advertisements targeting children. Guidelines says that advertisement targeting children shall not feature any personalities from the field of sports, music or cinema for products which under any law requires a health warning for such advertisement or cannot be purchased by children

Guidelines also stipulates that disclaimer shall not attempt to hide material information with respect to any claim made in such advertisement, the omission or absence of which is likely to make the advertisement deceptive or conceal its commercial intent and shall not attempt to correct a misleading claim made in an advertisement.

Similarly, clear Guidelines are laid for duties of manufacturer, service provider, advertiser and advertising agency, due diligence to be carried out before endorsing and others. Guidelines aims to protect consumer’s interest through bringing in more transparency and clarity in the way advertisements are being published, so that, consumers are able to make informed decisions based on facts rather than false narratives and exaggerations. 

Penalty for violating the Guidelines are also clearly outlined. CCPA can impose penalty of upto 10 lakh rupees on manufacturers, advertisers and endorsers for any misleading advertisements. For subsequent contraventions, CCPA may impose a penalty of upto 50 lakh rupees. The Authority can prohibit the endorser of a misleading advertisement from making any endorsement for upto 1 year and for subsequent contravention, prohibition can extend upto 3 years.

Click here to read Guidelines

Source: https://consumeraffairs.nic.in/en/latestnews/guidelines-prevention-misleading-advertisements-and-endorsements-misleading

CDSCO Notification

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Regulation of all Class A & B Medical Devices under Licensing regime, w.e.f 01.10.2022 – Regulator’s Notification

MoHFW has released a recent notification on Sep 30th 2022 about the Registration / Licensing norms for Medical Device Manufacturers, Importers for Class A and B Devices .

Content of the notification is shared below for information purposes :

  • The Ministry of Health & Family Welfare (MoHFW) has published notification vide S.O. 648 (E) dated 11.02.2020 specifying all medical devices under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, which is effective from 01.04 2020.
  • In order to regulate all the medical devices, MoHFW has published G.S.R. 102 (E) dated 11.02.2020 for regulation of such devices in phase wise manner. As per the said notification the Class A & B medical devices will be under licensing regime from 01.10.2022.
  • In the meantime, representations from various Associations and Stakeholders have been received by this office, requesting that the business continuity should not be disrupted due to the implementation of licensing regime w.e.f. 01.10.2022 for Class A & B medical devices.
  • In view of the above, it has been decided that, in case, if an existing importer/manufacturer who is already importing /manufacturing any of Class A or Class B Medical Devices, has submitted application to Central Licensing Authority or State Licensing Authority on or before 30.09.2022, as the case may be, for grant of import /manufacturing licence in respect of the said device(s) under the provisions of MDR, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import /manufacture the said device(s) up to 6 months from the date of issue of this order or till the time, the Central Licensing Authority or State Licensing Authority, as the case may be, takes a decision on the said application, whichever is earlier.

Notification can be downloaded from here

Download

Source – https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTA1Nw==

What the notification means ?

Manufacturers and importers of non notified devices (which are not regulated already) of Class A and B Categories were given time for 18 months timeframe – from April 2020 to Sep 30, 2021, to Voluntarily register their businesses and products sold by them in the market. This registration helps businesses to establish business identity with Regulator. Subsequent to this, thereafter, from October, 2021, Class A & B Medical Devices were brought under compulsory registration scheme up to 30th September- 2022. Regulator gave call of action to manufacturers and importers, to complete the mandatory registration process before 30th Sep 2022 as Licensing regime starts from Oct 1st 2022.

In the interim period, a draft notification was released by MoHFW inviting public comments about exempting Class A – non sterile and non measurement devices from Licensing . It was only a draft and no further announcement was made about the same. Members of the sector have assumed that this category of products was exempted . This interim notification has caused some confusion at the market place.

However, as per the recent notification, the status quo is clear where MoHFW has clarified that existing manufacturers, importers who were already manufacturing, importing Class A , B Devices in the market and who have already applied to CLA/SLA for License, after applying for voluntary or mandatory registration, can continue to operate in the market as their application for license will be deemed valid. They can continue to manufacture or import Class A, B devices for the next 6 months time from the date of this order or till the time the CLA/SLA takes a decision on the application whichever is earlier.

There are players who have not filed application under Voluntary & Mandatory registration process due to lack of awareness or various other business challenges and they are seeking clarification and guidance on how to apply now. They would like to know if they have to apply for Registration or Licensing now and if they are permitted to apply for Registration hereafter.

Some clarity and guidance from the Ministry on these concerns would certainly help the players/industry.

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