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


Australia’s Therapeutic Goods Administration (TGA) has issued guidelines to help manufacturers of spinal implants and medical devices that come in direct contact with the heart, central circulatory system (CCS) or central nervous system (CNS) to pass new regulatory requirements.

Currently, TGA treats spinal implants as Class IIb medical devices. Products in direct contact with the heart, SCC or CNS are class IIa. In 2019, TGA proposed to move certain spinal implants and all invasive surgical devices that come in direct contact with the heart, CTS or CNS to Class III as part of its efforts to align its regulations with the framework of the European Union. The devices are expected to join the new higher risk classification on November 25.

TGA has created guidance documents covering both sets of medical devices to help the industry transition to the new regulatory requirements. Both documents begin by explaining how the rules evolve and offer examples of the types of devices that will be affected, before providing a breakdown of how the new requirements will affect different businesses.

If an affected product is listed on the Australian Therapeutic Products Registry (ARTG) before November 25, the sponsor will have until May 25, 2022 to notify TGA that they have a device that will need to be reclassified. The sponsor will then have until November 1, 2024 to submit a request to add the product to class III. Sponsors who do not intend to request a reclassification must cancel their ARTG inclusions by May 25, 2022.

TGA will assess products in pending applications as of November 25 as Class IIa devices, then require sponsors to meet the same reclassification deadlines as their peers with devices already in the ARTG. The only difference is that sponsors with pending applications have until the latest date of May 25, 2022 or two months from their ARTG registration start date to tell TGA that their devices must be reclassified. Applications received after November 25 must comply with Class III rules.

Both documents also cover the process for applying for inclusion in Class III, with the Spinal Implants document containing additional information specific to this set of devices. Requests for inclusion of spinal implants must be accompanied by appropriate conformity assessment documentation. TGA will reject applications that do not contain the documents required in its preliminary assessment.

Promoters without conformity assessment certificates issued by the TGA will undergo mandatory application audits. Audits include the assessment of clinical evidence. Spinal implants which remain in class IIb are subject to different requirements.

Spine guidance, Following

Philippine FDA seeks comment on plans to use foreign regulators to inform decisions

The Philippine Food and Drug Administration (FDA) is holding a consultation on using the decisions of foreign regulators to inform its assessments. The FDA framed the proposals as a way to streamline its regulatory review processes and speed up drug registration.

With supply chains becoming increasingly globalized and complex, the FDA has said it is “strategic to establish trustworthy and cooperative regulatory practices” to deal with increasing complexity, costs and technical demands. regulatory oversight. This line of thinking led the FDA to propose the creation of facilitated registration pathways (FRPs) for pharmaceuticals, including vaccines and biologics.

FRPs will allow companies to benefit from an abbreviated review or verification of new applications and post-approval changes. To qualify for an abridged review, the applicant must present proof of approval from a Reference Drug Regulatory Authority (RDRA). The FDA plans to recognize seven RDRAs, including regulatory agencies in the United States, European Union, and Japan. Proof of approval from two RDRAs is required to be eligible for the verification exam.

The type of review dictates the timing of a decision. The FDA expects to complete abbreviated reviews in 90 business days and verification reviews in 45 business days. The agency can reject applications even if they are supported by positive RDRA decisions or request additional supporting documents.

The FDA is accepting comments on the proposals until October 5.

Draft proposal

CDSCO shares guide for registering medical devices not notified for import, production

India’s Central Pharmaceutical Standards Control Organization (CDSCO) has published the steps that non-notified medical device manufacturers and importers must take to register their products.

Last year, Indian authorities presented plans to classify unreported medical devices such as gowns and surgical drapes as low or low to moderate risk Class A or B products and grant manufacturers and importers time-limited exemptions from certain aspects of incoming regulations. . CDSCO has now followed with a guide to registering non-notified medical devices.

The guide directs importers and manufacturers of unreported medical devices to a website where they can download the 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 must provide to register their medical devices. Both groups of companies must provide a certificate of compliance with ISO 13485, which covers quality management systems, “accredited by the National Council for Accreditation of Certification Bodies or the International Accreditation Forum”.

CDSCO Guide

Malaysian NPRA creates new regulatory services for permits and pre-submission meetings

Malaysia’s National Medicines Regulatory Agency (NPRA) has created two new departments covering pre-submission meetings and collection of permits, certificates and licenses.

Through the pre-submission meeting service, the ONPR will provide regulatory advice regarding the quality, safety and efficacy of an investigational product. The notice is intended to help businesses prepare for registration applications. Companies interested in hosting a pre-submission meeting can apply via email.

The NPRA shared details of the service as well as information on another offering. The second service is a collection center for permits, certificates and licenses. Applicants can now pick up their documents from the one-stop-shop at the NPRA offices.

ONPR opinion, Following

Philippine FDA postpones enforcement action against unlicensed medical gas producers

The Philippine FDA has asked its field staff to defer all enforcement action against facilities that manufacture medical gases without the required operating license (LTO), provided certain conditions are met.

The FDA gives flexibility to facilities that already have an LTO application and a Certificate of Inspection Compliance (COC). Facilities must receive an LTO within 60 days of issuance of the COC. The FDA will continue to defer enforcement action against facilities manufacturing medical gases during the duration of the national public health emergency.

The Philippines has been rushing to increase the supply of medical oxygen in recent weeks in response to the COVID-19 crisis. Australia and Taiwan donated oxygen concentrators and preparations are underway for the first state oxygen plant in the Sorsogon region of the Philippines.

Covid-19 case Pink rapidly in the Philippines throughout August and the first half of September when the delta variant took hold, but has started to decline just as rapidly in recent days.

FDA Notice

Other news:

The Philippine FDA has finalized its guidance on post-market surveillance requirements for new drugs made available through supervised release. The final guide, which comes a few weeks after the publication of a draft for consultation, describes the use of risk management and pharmacovigilance plans to further characterize the safety of a product. FDA guidelines

© 2021 Society of Regulatory Affairs Professionals.

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