Indian Devicemakers Push for Early Implementation of Packaging Rules
Indian devicemakers have urged the government not to extend a deadline for implementing new packaging rules.
The new rules, which were originally scheduled to be implemented in January 2018, require manufacturers to declare country of origin, date of manufacture, quantity and expiration dates for all pre-packaged devices.
The Association of Indian Medical Device Industry said Indian devicemakers were ready to comply with the new rules and they should be implemented as soon as possible. An AiMED spokesperson said the government was hurting Indian devicemakers by delaying implementation because other international companies were able to put products on the market that may not comply with the new requirements.
MHRA Recalls Novaline Hemodialysis Bloodlines
The UK’s Medicines and Healthcare products Regulatory Agency issued a massive recall of NovaLine bloodlines used with Baxter/Gambro dialysis machines.
Manufactured by Vital Healthcare, the recall affects all lots of NovaLine tubing sets for hemodialysis that were manufactured in 2017. Specific product codes manufactured in 2017 have functional and assembly issues that may lead to air entering the system, blood loss, clotting and delays in treatment, the manufacturer said in the field safety notice.
The agency listed seven possible failures of the devices and actions customers should take to mitigate the risks. The manufacturer said all affected products should be removed from inventories.
Switzerland Overhauls Device Manufacturing Certificate Process
Swiss Medic will overhaul the way it issues export certificates and manufacturing certificates for devices in the fall and introduce new fees that take effect on Jan. 1, 2019.
Export certificates and manufacturing certificates are issued for countries that don’t recognize European CE marking, and the increased demand was becoming unsustainable, the agency said.
Upcoming changes include clear requirements for submitting documents and product lists, electronic submissions, fee adjustments, and new service agreements that outline the scope of services Swiss Medic will provide, as well as the entitlements and obligations of the companies.