Asia-Pacific Roundup: TGA Seeks Comments on Classification of Skin Applied Devices
Australia’s Therapeutic Goods Administration (TGA) has launched a consultation on improvements to the regulation of certain medical devices. The proposals apply to devices which are substances introduced into the human body through a port or applied to the skin.
The TGA has released the proposals as part of its efforts to reclassify certain categories of medical devices to align with the new EU regulatory framework. Medical devices consisting of substances introduced into the body through a body orifice or applied to the skin are one of six product categories covered by Australian legislation introduced in late 2019. The law, which creates new classification rules for devices medical, is scheduled to take effect on November 25.
After reviewing feedback from consumers, healthcare professionals, hospitals and medical device companies, TGA is proposing further regulatory improvements. Although the original proposal is aligned with the EU regulation, TGA is now questioning whether full alignment is appropriate given the overlapping drug and medical device regulatory frameworks in Australia for some products.
In the face of this overlap, TGA is considering deleting references to products that are routinely absorbed because they meet the Australian definition of a drug. The plan is to remove two lines on products that “are systematically absorbed by the human body”. In doing so, TGA aims to address regulatory inconsistencies that could arise if products are classified as drugs and devices.
The guide provides examples of how regulations will affect certain types of products. A nasal saline spray, for example, will be upgraded from Class I to Class IIa when the law comes into force. The TGA will classify sprays that use isotonic saline to irrigate the nasal cavity as medical devices, while products that use hypertonic saline that has an osmotic effect in the nasal cavity will be classified as drugs.
TGA is accepting comments until August 13. The agency said the comments would help it identify problems that could arise if the regulations were changed and support its efforts to tailor the stakeholder training program to the product class.
Malaysia issues guidance on conditional disaster registration
The Malaysian National Drug Regulatory Agency (NPRA) has issued guidelines on conditional registration of pharmaceuticals in disasters. The NPRA released the guidelines after realizing that developers of COVID-19 drugs and vaccines without Phase 3 data did not have a path to full registration.
The guidelines apply to pharmaceuticals, including vaccines, intended for use in response to situations that Malaysian authorities have declared catastrophic. Developers are eligible for conditional registration if existing interventions have failed to eradicate the disease or prevent outbreaks, if they have at least preliminary data on the safety and effectiveness of a clinical study of well planned phase 3, and if the product is already authorized for use in certain overseas territories.
The ONPR will give priority review requests for conditional registration, which means it should make a decision within 120 business days of receiving a request. Review time will be “considerably” shorter if the product has been approved for use in a reference country or by the World Health Organization. Conditional registrations will last for one year and may be renewed twice.
The guide lists the data applicants will need to provide. For vaccines, the NPRA expects applicants to have monitored “well over” 3,000 product recipients for serious adverse events and adverse events of special interest for at least one month after completing the full regimen. .
India caps trade margins on pulse oximeters and other medical devices
India has capped trade margins on pulse oximeters and four other types of medical devices. The action reflects a desire to regulate the prices of medical devices deemed essential to the management of the COVID-19 pandemic.
India’s National Pharmaceutical Pricing Authority (NPPA) has recorded device marketing margins of up to 709%. In response, the Indian government capped the trade margin at 70%. The cap will affect the maximum retail price (MRP), as shown in a formula that shows how to calculate MRP based on the markup and the distributor price.
India has applied the cap to pulse oximeters, blood pressure monitors, nebulizers, digital thermometers and blood glucose meters. The action follows the imposition of a cap on the marketing margins of oxygen concentrators, which, according to the government, “resulted in significant savings for the consumer and a rationalization of the price”.
The revised prices for the five newly capped products went into effect on July 20. The NPPA has asked affected manufacturers and importers to share their new post-cap MRPs by July 20.
Philippines releases draft guidelines on banning mercury-based medical products
The Philippine Food and Drug Administration (FDA) is seeking comment on plans to ban thermometers and medical products containing mercury.
Last year, the Philippine government signed an international treaty to protect humans and the environment from mercury and related compounds. The signing followed earlier advisories regarding the phase-out of mercury in all Philippine health facilities and stopping the use of mercury in dental restorative procedures.
Now, the FDA has followed through on a draft guidance that will “strictly” ban trade in thermometers and sphygmomanometers containing mercury and ban the import of liquid mercury and dental amalgam capsules for use in dental procedures. dental restoration. The sale of used thermometers and sphygmomanometers containing mercury will also be prohibited.
The FDA places the responsibility for removing mercury-containing thermometers and sphygmomanometers from the market on “the manufacturer, trader, distributor, importer, exporter, wholesaler.” Removed devices must be disposed of in accordance with the requirements of the Department of the Environment and Natural Resources.
The project is open for comments until August 14. The FDA plans to enforce the ban on thermometers and sphygmomanometers containing mercury 30 days after the proposed policy takes effect. Distributors and retailers of dental amalgam capsules will have until June 2023 “to exhaust their remaining stocks in the market”.
India applies risk classifications to anesthesiology medical devices
The Drugs Controller General of India (DCGI) has published the risk classifications for anesthesiology medical devices.
Under the Medical Devices Rules, 2017, India divides medical technology products according to their risks. The process resulted in a list of 112 types of medical devices used in anesthesia procedures. Each type of medical device has a risk classification ranging from A to D.
DCGI has classified most products as low risk categories A and B. Aerosol delivery tubes and respiratory oxygen monitors are class A and class B devices. The list also includes some class C and class D devices. DCGI has placed the electronic control units of epidural spatial localization and spinal needle bioimpedance navigation units in class D.
The publication of the list follows the classification of other types of medical devices by risk. In 2019, the Central Drugs Standard Control Organization proposed risk classifications for products, including CT scanners, X-ray machines, and nebulizers.
The China Center for Drug Evaluation (CDE) is seeking comments on the draft guidelines for clinical trials of ulcerative colitis treatments. The guidelines aim to standardize the clinical development of drugs for inflammatory disease. The CDE accepts comments for one month. CDE Notice (Chinese)
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