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Malayalam cinema, also known as Mollywood, is a thriving film industry based in Kerala, India. With a rich history spanning over a century, Malayalam cinema has evolved into a significant part of Kerala's culture, reflecting the state's values, traditions, and social issues. The industry has produced numerous acclaimed filmmakers, actors, and films that have gained national and international recognition.
The first Malayalam film, "Balan," was released in 1938, marking the beginning of the industry. However, it was not until the 1950s and 1960s that Malayalam cinema gained momentum, with films like "Nokketha Doorathu Kannum Nattu" (1950) and "Adoor" (1961). The 1970s and 1980s saw the rise of notable filmmakers like Adoor Gopalakrishnan, K. S. Sethumadhavan, and I. V. Sasi, who made significant contributions to the industry. Malayalam cinema, also known as Mollywood, is a
Malayalam cinema is a vital part of Kerala's culture, reflecting the state's values, traditions, and social issues. With a rich history, notable filmmakers, and talented actors, the industry continues to thrive and entertain audiences. As Kerala's cultural heritage evolves, Malayalam cinema is poised to play an increasingly important role in showcasing the state's unique identity to the world. The first Malayalam film, "Balan," was released in
Hello
We are company of medical device type II (sterelised needle) .Level of packagings are as following:
1 ) blister (direct packaging)
2) Dispenser 30 or 100 units
3) Shelf (about 1400 dispensers)
4) Shipper same as shelf (protective carton)
1)What is the alternative at blister packaging level , if we not indicate the manufacturer details : IFU, UDI etc is allow instead ?
2) same questions on Shipper level : what is the laternative ?
In Europe,US, Canada, turkie ?
3) What are the symbol that are mandatory according with packaging level?
Dear Nathalie,
the labeling on the sterile barrier system (SBS) – I assume in your case blister level, as these maintain the sterility of your device – is regulated either by the MDR (in Europe and also Türkiye) or by the recognized consensus standard ISO 11607-1 (EU, Türkiye, USA and Canada). In any case, the regulations require the manufacturer details directly on the SBS, there is no alternative.
Or are your devices not sold individually but only in the dispensers as the point of use? Then this dispenser could be considered as the outer protective packaging of your SBS and carry all required information.
The shipping packaging is only intended for transport and thus is not considered an additional packaging level, and as such is not required to fulfill any regulatory requirements. However, in certain cases (e.g. customs) a clear indication of the manufacturer is required to make the shipment traceable.
The information required on the packaging can be found in the MDR and 21 CFR part 801 as well as ISO 11607-1, the corresponding symbols in ISO 15223-1.
Let us know if we should discuss this in more detail in a short workshop, based specifically on your own device.
Kind regards
Christopher Seib