Asia Regulatory Roundup: TGA Rethinks Reclassification of Implants After Pushback

RoundupsRoundups | 10 March 2020 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Rethinks Regulatory Reclassification of Implants After Pushback
Australia’s Therapeutic Goods Administration (TGA) has revised its approach to the reclassification of certain medical implants after receiving feedback on its plans. TGA received broad support for some of its proposals, leading it to push ahead with its plans, but criticism of its planned approach to two types of implants drove it to change its handling of those devices.
Around one year ago, TGA sought feedback on its plans to reclassify certain medical devices in light of changes to their regulatory status in the European Union. The proposed changes included the upclassification of all spinal implants, with the exception of some ancillary components, from Class IIb to Class III. TGA also proposed reclassifying active implantable medical devices (AIMD) and related accessories as Class III devices. Neither proposal met with universal approval.
The Medical Technology Association of Australia (MTAA), for example, argued the AIMD changes would “impose unreasonable burden on manufacturers and sponsors, disproportionate with their intrinsic risk.” MTAA also called for TGA to invite spine surgeons and others to a roundtable to discuss the upclassification of orthopedic implants before pushing ahead with the planned changes.
TGA heeded the feedback, leading it to hold further discussions about its approach to AIMDs and spinal implants. Having completed the talks, TGA has changed its stance on the two sets of implants.
The agency now plans to treat rods, plates and other implantable instruments used in spinal fusion procedures as Class IIb devices. Only motion-preserving devices, such as a spinal disc replacement, and implants that come into contact with the spinal column will go up to Class III.
TGA has also softened its position on AIMDs. Responding to feedback from industry, TGA has backed away from plans to group all AIMD accessories in Class III. The revised plan is to treat long-term surgically invasive and implantable accessories to AIMDs as Class III devices. Active devices for use in the control or monitoring of AIMDs will remain in Class III, but other types of accessories will stay in lower risk categories.
The process of reaching agreement on the other four categories of medical devices was more straightforward. TGA received broad support for its plans to reclassify those devices, leading it to push ahead with the changes it floated last year.
TGA Statement
Industry Seeks Changes to India’s API and Formulation Export Ban
The Pharmaceutical Export Promotion Council of India (Pharmexcil) has called for the government to change parts of its ban on the export of certain active pharmaceutical ingredients (APIs) and finished products.
Officials at the Indian Directorate General of Foreign Trade (DGFT) imposed restrictions on exports of 13 APIs and formulations, including those containing paracetamol, amid concerns that rising demand in foreign markets grappling with coronavirus will create shortages in India. Faced with that prospect, DGTF changed the export status of the 13 items from “free” to “restricted.”
Exactly how tight the restrictions should be is now a matter of debate. In a notice to disclose and explain the regulatory change to its members, Pharmexcil outlined aspects of the policy that it wants the government to amend.
“Pharmexcil is also representing the matter to the DGFT for relaxing the restrictions on the shipments lying at ports and also for the supplies meant for other countries,” the export council wrote.
According to PharmaBiz, Pharmexcil is seeking the changes as some products cannot be used within India. Given that the products have a finite shelf life, a prolonged ban on the export of the materials could make it impossible to sell them internationally or use them domestically, causing waste and lost revenues. Pharmexcil is lobbying DGFT to try to avert that outcome.
Pharmexcil Statement, DGTF Notice, PharmaBiz
TGA Pushes Ahead With Move to Self-Testing After Consultation
TGA is pushing ahead with plans to permit more self-test in vitro diagnostics (IVD). Respondents to a consultation on the topic voiced support for the expansion of self-testing into new areas, leading TGA to plan further targeted discussions to finalize its plans.
Australia has allowed the sale of self-test IVDs for HIV since 2014. Last year, TGA began the process of establishing whether other types of IVD should be made available for self-use, despite it still having concerns about the accuracy of some self-tests and access to support services among people who use them.
The consultation revealed support among most respondents for self-testing for influenza. A smaller number of respondents also said self-tests for pathogens including hepatitis C, respiratory syncytial virus and sexually transmitted infections could be safely made available in the future.
TGA received more negative feedback about the use of self-tests in other contexts. Most respondents came out strongly in favor of maintaining restrictions on the supply of genetic self-tests. However, with Australians importing personal genetic tests from overseas, some respondents also proposed ways to make the products available in the country and, in doing so, better regulate the sector.
The responses to the prospect of cancer self-testing were stronger still, with no respondents seeing particular benefits to consumers of making such IVDs available. Rather, several respondents argued for the continued prohibition of cancer self-tests on the grounds that they are high-risk.
TGA Statement
Australian Court Orders J&J to pay $1.7M in Pelvic Mesh Class Action
The Federal Court of Australia has ordered Johnson & Johnson to pay AU$2.6 million ($1.7 million) to three women who brought a class action pelvic mesh case. J&J is set to make payouts to the women, the lead applicants in the class action, in relation to last year’s loss of a case brought by more than 1,300 people.
In November, the court ruled that J&J’s Ethicon unit failed to adequately warn patients and surgeons about the risks related to its pelvic mesh products. At that time, the court analyzed the requests for damages submitted by the applicants, as well as J&J’s response, and proposed amounts when the two sides were unable to reach an agreement. However, the November ruling lacked final totals for damages for the lead applicants.
The court published those final figures last week. The parties agreed the lead applicant will receive damages of AU$1.3 million, with the other two women sharing a similar amount between them.
In November, the judge found fault with aspects of the request for damages, stating that “on no view of the matter is [the lead applicant] entitled to damages or compensation calculated in the manner advanced by her lawyers.” The judge also rejected some of the claims for damages brought by the applicants, for example by turning down requests for money to cover the cost of taxis and a nerve stimulator.
The nature of the damages agreed to by the judge vary from woman to woman, although in each case money for past and future domestic assistance and non-economic loss are among the biggest line items. With damages for the lead applicants now set, the law firm that represented the women said, “Issues common to group member claims arising out of the judgment will be determined in coming days.”
That process will move the other women who brought the case a step closer to receiving damages. The judge asked the parties to develop a framework for processing the claims of individual women by the end of June.
Court Ruling, Press Release


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