Regulatory Focus™ > News Articles > 2021 > 9 > Asia-Pacific Roundup: TGA posts guidance on reclassification of certain implantable devices

Asia-Pacific Roundup: TGA posts guidance on reclassification of certain implantable devices

Posted 28 September 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: TGA posts guidance on reclassification of certain implantable devices

Australia’s Therapeutic Goods Administration (TGA) has released guidance to help manufacturers of spinal implants and medical devices that come into direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) to transition to new regulatory requirements.
 
Currently, TGA treats spinal implants as Class IIb medical devices. Products in direct contact with the heart, CCS or CNS are in Class IIa. In 2019, TGA proposed moving some spinal implants and all surgically invasive devices that come into direct contact with the heart, CCS or CNS to Class III as part of its effort to align its regulations with the European Union framework. The devices are set to join the new, higher risk classification on 25 November.
 
TGA has created guidance documents covering the two sets of medical devices to help the industry transition to the new regulatory requirements. Both documents begin by explaining how the rules are changing and offering examples of the types of devices that will be affected, before providing a breakdown of how the new requirements will affect different companies.
 
If an affected product is included in the Australian Register of Therapeutic Goods (ARTG) before 25 November, the sponsor will have until 25 May 2022 to tell TGA that it has a device that will need to be reclassified. The sponsor will then have until 1 November 2024 to submit an application for the product to be added to Class III. Sponsors that do not intend to seek reclassification should cancel their ARTG inclusions before 25 May 2022.
 
TGA will assess products in applications that are pending as of 25 November as Class IIa devices and then make sponsors meet the same timelines for reclassification as their peers with devices that are already in the ARTG. The only difference is sponsors with pending applications have until whichever is the later date of 25 May 2022 or two months of the start date of their ARTG entry to tell TGA their devices need reclassifying. Filings received after 25 November must meet Class III rules.
 
Both documents also cover the process for seeking inclusion in Class III, with the document on spinal implants containing additional information specific to that set of devices. Applications for inclusion of spinal implants must be accompanied by appropriate conformity assessment documentation. TGA will reject applications that lack the required paperwork in its preliminary assessment.
 
Sponsors without TGA-issued conformity assessment certificates will undergo compulsory application audits. The audits include the assessment of clinical evidence. Spinal implants that are staying in Class IIb are subject to different requirements.
 
Spinal Guidance, More
 
Philippine FDA seeks feedback on plans to use foreign regulators to inform decisions
 
The Philippine Food and Drug Administration (FDA) is holding a consultation into the use of decisions by overseas regulators to inform its assessments. FDA framed the proposals as a way to streamline its regulatory review processes and accelerate the registration of medicines.
 
With supply chains becoming more globalized and complex, FDA said it is “strategic to establish regulatory reliance and cooperation practices” to cope with the increasing complexity, cost and technical requirements of regulatory oversight. That line of thinking led FDA to propose creating facilitated registration pathways (FRPs) for drug products, including vaccines and biologicals.
 
FRPs will enable companies to benefit from abridged or verification review of new applications and post-approval changes. To benefit from abridged review, the applicant must submit proof of approval from a reference drug regulatory authority (RDRA). FDA plans to recognize seven RDRAs, including the regulatory agencies in the US, European Union and Japan. Proof of approval from two RDRAs is needed to be eligible for verification review.
 
The type of review dictates the timeline to a decision. FDA plans to complete abridged reviews in 90 working days and verification reviews in 45 working days. The agency may reject applications even if they are supported by positive decisions by RDRAs or request additional supporting documents.
 
FDA is accepting feedback on the proposals until 5 October.
 
Draft Proposal
 
CDSCO shares guide to registering non-notified medical devices for import, production
 
India’s Central Drugs Standard Control Organization (CDSCO) has published the steps manufacturers and importers of non-notified medical devices need to follow to register their products.
 
Last year, Indian authorities outlined plans to classify non-notified medical devices such as gowns and surgical drapes as low- or low-to-moderate risk Class A or B products and to grant manufacturers and importers time-limited exemptions from aspects of incoming regulations. CDSCO has now followed up with a guide to registering non-notified medical devices.
 
The guide directs importers and manufacturers of non-notified medical devices to a website where they can upload documents required to register on the portal, such as a copy of the manufacturing or wholesale licenses.
 
The rest of the guide covers the different sets of documents that manufacturers and importers need to provide to register their medical devices. Both sets of companies need to provide a certificate of compliance with ISO 13485, which covers quality management systems, “accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum.”
 
CDSCO Guide
 
Malaysia’s NPRA creates new regulatory services for permits, pre-submission meetings
 
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has created two new services covering pre-submission meetings and the collection of permits, certificates and licenses.
 
Through the pre-submission meeting service, NPRA will provide regulatory advice related to the quality, safety and efficacy of an investigational product. The advice is intended to help companies prepare submissions for registration. Companies interested in holding a pre-submission meeting can make a request via email.
 
NPRA shared details of the service alongside information about another offering. The second service is a collection hub for permits, certificates and licenses. Applicants can now collect their paperwork from the One Stop Centre at NPRA’s offices. 
 
NPRA Notice, More
 
Philippine FDA defers enforcement actions against unlicensed producers of medical gas
 
The Philippine FDA has told its staff in the field to defer all regulatory enforcement actions against facilities that are found to be manufacturing medical gases without the required License to Operate (LTO), provided certain conditions are met.
 
FDA is granting the leeway to facilities that have an existing application for LTO and an inspection Certificate of Compliance (COC). Facilities need to receive a LTO within 60 days of the issuance of the COC. FDA will continue to defer regulatory enforcement actions against facilities making medical gases for the duration of the national public health emergency.
 
The Philippines has raced to increase the supply of medical oxygen in recent weeks in response to the COVID-19 crisis. Australia and Taiwan have donated oxygen concentrators and preparations are underway for the first state-owned oxygen plant in the Sorsogon region of the Philippines.
 
COVID-19 cases rose quickly in the Philippines throughout August and the first half of September as the delta variant took hold, but have begun to decline just as rapidly in recent days.
 
FDA Notice
 
Other News:
 
The Philippine FDA has finalized its guidance on the post-market surveillance requirements of new drugs made available under monitored release. The final guidance, which comes weeks after the release of a draft for consultation, describes the use of risk management and pharmacovigilance plans to further characterize the safety of a product. FDA Guidance

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe