Regulatory Focus™ > News Articles > 2021 > 7 > Asia-Pacific Roundup: TGA seeks feedback on classification of devices applied to the skin

Asia-Pacific Roundup: TGA seeks feedback on classification of devices applied to the skin

Posted 20 July 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA seeks feedback on classification of devices applied to the skin

Australia’s Therapeutic Goods Administration (TGA) has begun a consultation on refinements to the regulation of some medical devices. The proposals apply to devices that are substances introduced into the human body via an orifice or applied to the skin.
 
TGA published the proposals as part of its efforts to reclassify certain categories of medical devices so that they align with the new regulatory framework in the EU. Medical devices that consist of substances introduced into the body via a body orifice or applied to the skin are one of the six categories of products covered by Australian legislation introduced late in 2019. The law, which creates new classification rules for the medical devices, is set to take effect on 25 November.
 
Having reviewed feedback from consumers, healthcare professionals, hospitals and medical device companies, TGA is proposing further refinements to the regulations. While the original proposal is aligned with the EU regulation, TGA is now questioning whether full alignment is appropriate given overlap in the medicine and medical device regulatory frameworks in Australia for some products.
 
Faced with that overlap, TGA is planning to remove references to products that are systemically absorbed because they meet the Australian definition of a medicine. The plan is to delete two lines about products that “are systemically absorbed by the human body.” In doing so, TGA is aiming to address regulatory inconsistencies that could arise if products are classed as medicines and devices.
 
The guidance features examples of how the regulations will affect certain types of products. A saline nasal solution spray, for example, will go from Class I to Class IIa when the law takes effect. TGA will classify sprays that use isotonic saline to irrigate the nasal cavity as medical devices, whereas products that use hypertonic saline that has an osmotic effect in the nasal cavity will be classified as medicines.
 
TGA is accepting feedback until 13 August. The agency said the feedback will help it identify issues that may arise if the regulations are changed and support its efforts to tailor the stakeholder education program for the class of products.
 
TGA Consultation
 
Malaysia publishes guidance on conditional registration during disasters
 
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has published guidance on conditional registration of pharmaceutical products during disasters. NPRA published the guidance after realizing developers of COVID-19 drugs and vaccines without Phase 3 data lacked a path to full registration.
 
The guidance applies to pharmaceutical products, including vaccines, intended for use in response to situations that Malaysian authorities have declared to be disasters. 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 safety and efficacy from one well-planned Phase 3 clinical study, and if the product is already cleared for use in certain overseas territories.
 
NPRA will give applications for conditional registration priority review, meaning it should make a decision within 120 working days of receiving a submission. The review time will be “significantly” shorter if the product has been cleared for use in a reference country or by the World Health Organization. Conditional registrations will last one year and can be renewed twice.
 
The guidance lists the data applicants will need to provide. For vaccines, NPRA expects applicants to have monitored “well over” 3,000 recipients of the products for serious adverse events and adverse events of special interest for at least one month after the completion of the full regimen.
 
NPRA Guidance
 
India caps the trade margins on pulse oximeters, other medical devices
 
India has capped the trade margins on pulse oximeters and four other types of medical devices. The action reflects a desire to regulate the prices of medical devices that are deemed to be essential to the management of the COVID-19 pandemic.
 
The National Pharmaceutical Pricing Authority (NPPA) of India has seen trade margins on the devices as high as 709%. In response, the Indian government has capped the trade margin at 70%. The cap will affect the maximum retail price (MRP), as is set out in a formula that shows how to calculate the MRP based on the trade margin and price to the distributor.
 
India has applied the cap to pulse oximeters, blood pressure monitoring machines, nebulizers, digital thermometers and glucometers. The action follows the imposition of a cap on the trade margins of oxygen concentrators, which the government said, “Resulted in significant savings to the consumer and rationalization in the price.”
 
The revised prices on the five newly capped products took effect on 20 July. NPPA asked affected manufacturers and importers to share their new, post-cap MRPs by 20 July. 
 
NPPA Notice
 
Philippines posts draft guidance on banning mercury-based medical products
 
The Philippine Food and Drug Administration (FDA) is seeking feedback on plans to ban thermometers and medical products that contain mercury.
 
Last year, the Philippine government signed an international treaty designed to protect humans and the environment from mercury and related compounds. The signing followed earlier notices about gradually phasing out mercury in all Philippine healthcare facilities and stopping the use of mercury in dental restoration procedures.
 
Now, FDA has followed up with draft guidance that will “strictly” prohibit trade in mercury-containing thermometers and sphygmomanometers and ban importation of liquid mercury and dental amalgam capsules for use in dental restoration procedures. Sales of second-hand mercury-containing thermometers and sphygmomanometers will also be prohibited.
 
FDA is placing 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 line with the requirements of the Department of Environment and Natural Resources.
 
The draft is open for comment until 14 August. FDA plans to apply the ban on mercury-containing thermometers and sphygmomanometers 30 days after the draft policy takes effect. Distributors and retailers of dental amalgam capsules will have until June 2023 “to exhaust their remaining stocks in the market.”
 
FDA Notice
 
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 is dividing medtech products up based on their risks. The process has resulted in a list of 112 types of medical devices used in anesthesiology procedures. Each type of medical device has a risk classification ranging from A to D. 
 
DCGI has put most of the products in the lower-risk A and B categories. Aerosol delivery tubes and respiratory oxygen monitors are among the devices in Class A and Class B. The list also features some Class C and Class D devices. DCGI put electronic epidural space locator control units and spinal needle bioimpedance navigation units in Class D.
 
The release of the list follows the classification of other types of medical device by risk. In 2019, the Central Drugs Standard Control Organization proposed risk classifications for products including CT scanners, X-ray machines and nebulizers.
 
DCGI Notice
 
Other News:
 
China’s Center for Drug Evaluation (CDE) is seeking feedback on draft guidelines about clinical trials of ulcerative colitis treatments. The guidance is intended to standardize clinical development of drugs for the inflammatory disease. CDE is accepting feedback for one month. CDE Notice (Chinese)

 

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