Asia-Pacific Roundup: India defers enforcement of licensing requirements on higher-risk medical devices

India’s Central Drugs Standard Control Organization (CDSCO) has delayed the enforcement of new rules on Class C and D medical devices in response to feedback.

In 2020, Indian officials outlined plans to revise the regulation of medical devices. CDSCO adopted a phased approach, requiring manufacturers of low and low-moderate risk devices to comply with the new rules and obtain a license in 2022. But CDSCO delayed the enforcement of the requirements on higher-risk Class C and D products until 1 October 2023.

Last week, CDSCO said that some manufacturers that have yet to get the required licenses for Class C and D products can continue to sell their medical devices. Industry representatives asked CDSCO to change the transition timeline for the sake of “business continuity.”

In response, the agency has agreed to give more time to companies that have submitted an application but have yet to receive a license. If a manufacturer or importer filed an application by the end of September 2023, CDSCO will allow the company to continue to sell the medical device for up to six months. The regulatory flexibility will end when CDSCO rules on the application or at the end of six months.

CDSCO published its notice days after the National Pharmaceutical Pricing Authority (NPPA) clarified its earlier comments on the price of orthopedic knee implants. In September, NPPA told the industry that it would monitor the prices of knee implants for another year, as it has done since it first set a maximum price for the devices in 2017. But last week, the authority clarified its earlier notice after receiving requests from stakeholders. The Indian price watchdog explained that manufacturers and importers can increase “maximum retail prices (MRP) of knee implants up to 10% of MRP during [the] preceding 12 months.”

CDSCO Notice, NPPA Notice, More

Indian Pharmacopoeia seeks feedback on monograph updates

The Indian Pharmacopoeia Commission (IPC) has released draft changes to the monographs of three substances for consultation. IPC is accepting feedback until 24 November 2023 and plans to implement the changes in January 2026.

In the consultation document, IPC outlines proposed changes to the monographs for morphine sulphate injection, ceftriaxone sodium and ceftriaxone injection. All of the changes relate to sections on bacterial endotoxins. IPC is considering revising the wording of the morphine sulphate text, adding “sulphate” to two existing uses of “morphine,” and altering the endotoxin limit for the other two substances.

Currently, the two ceftriaxone monographs state that the substances should contain “not more than 0.20 Endotoxins Units per mg.” IPC is seeking feedback on plans to lower the limit to 0.08 Endotoxins Units per mg.

The start of the consultation coincided with IPC’s acceptance into the Pharmacopoeial Discussion Group, a global body set up by authorities in Europe, Japan and the US to drive harmonization. IPC joined for a one-year pilot project last year and has now been accepted on a permanent basis.

IPC Notice, Press Release

HSA finds no evidence of product-related dermal filler safety and quality issues

Singapore’s Health Sciences Authority (HSA) has completed its investigation into AestheFill without finding evidence of product-related safety and quality issues.

HSA began the investigation after Parvus, the product registrant, submitted an adverse event report that described an individual who went blind after receiving the dermal filler. The person experienced blood vessel occlusion leading to blindness. The report was the first case linking a dermal filler to blindness in Singapore, although the complication has been seen for years in the rest of the world.

The report led HSA to review the device history records for the lot of AestheFill associated with the adverse event. The records covered quality checks, the certificate of analysis and other aspects of the manufacturing process. HSA found the results of all chemical and microbiological tests were within the specifications.

HSA concluded that the product was manufactured according to the required standards and was safe for use, but how the dermal filler is used can influence its safety. The instructions for use warn against injecting AestheFill into blood vessels because of the risk of blockages. Parvus will strengthen its training of healthcare professionals, retrain existing providers and develop a leaflet to mitigate the risk, according to HSA.

HSA Notice

Philippine FDA shares guidance on training for external stakeholders

The Food and Drug Administration (FDA) of the Philippines has finalized guidance on the conduct of training and seminar sessions for external stakeholders to support face-to-face and online events.

FDA began seeking feedback on a draft earlier this year, framing the document as part of its effort to resume face-to-face meetings as COVID-19 restrictions were lifted. Now, almost five months after closing the comment period on the draft, the administration has published a final version that retains the core content but features changes throughout the document.

The regulator has revised the rationale for the guidance, dropping references to COVID-19 and reframing the text as a response to the need to provide training and seminars to a large number of stakeholders, both face-to-face and through online videos, and to “institutionalize an online registration procedure.”

FDA has added sections on the collection of registration fees and the guidelines for pre-recorded videos. The final guidance explains that FDA will offer pre-recorded videos for free via an online platform and require participants to register and “accomplish the pre-test.” FDA will provide links and QR codes to registration forms for both free and paid training sessions.

FDA Notice

CDSCO updates instructions on submitting ‘bulky dossiers’ to fix filing problems

India’s CDSCO has updated its instructions for submitting “bulky dossiers” after encountering problems that led to the “non-receipt of documents from the stakeholders in soft copy.”

In the notice, CDSCO explains that since it began using a separate web domain for its e-office, the clinical research unit has received hard copies of dossiers and other documents. “This is due to non-receipt of documents from the stakeholders in soft copy,” CDSCO wrote. The situation has led CDSCO to issue two sets of instructions.

First, the regulator said “stakeholders may be directed to submit the bulky dossiers, documents, query replies, etc. in the form of soft copy in the form of CD/pen drive in the scanned copy.” CDSCO prefers the copies in PDF files of 20 MB or smaller. Second, bulky dossiers, documents and query replies may also be sent via email, preferably as scanned PDFs that are smaller than 20 MB.

CDSCO Notice

Other News:

The Drug Regulatory Authority of Pakistan (DRAP) has published a recall alert about Abbott’s Trifecta heart valve replacement devices. Abbott withdrew the medical devices from the market earlier this year in response to data on the risk of early deterioration. DRAP’s notice explains how the actions will impact patients and healthcare professionals in Pakistan. DRAP Notice

HSA has authorized an updated version of Moderna’s COVID-19 vaccine for use in Singapore. The vaccine is designed to protect against the Omicron XBB.1.5 variant, providing better protection against currently circulating forms of the virus. HSA reviewed data on immune responses against the predominant circulating Omicron subvariants. HSA Notice

Asia-Pacific Roundup: India defers enforcement of licensing requirements on higher-risk medical devices

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