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Asia Regulatory Roundup: India Adopts Essential Principles on Safety and Performance of Devices

Posted 01 May 2018 | By Nick Paul Taylor 

Asia Regulatory Roundup: India Adopts Essential Principles on Safety and Performance of Devices

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India Adopts Essential Principles on the Safety and Performance of Medical Devices
India has adopted essential principles on the safety and performance of medical devices. The move finalizes and enacts last year’s draft document to establish core standards that all medical devices sold in India must meet.
Officials have made few, if any, changes to the text as a result of the consultation performed in the second half of last year. The result is the final document has retained the structure, focus and flexible approach to the meeting of standards that characterized the original text. Like the draft, the finalized document establishes principles for all device manufacturers to follow and subsets of standards aimed at producers of specific types of product without making prescriptive recommendations.
India’s willingness to give manufacturers leeway to decide how to create devices that comply with its essential principles is evident in each of the seven standards that apply to all types of product. This includes following safety-focused principles.
“The solutions adopted by the manufacturer for the design and manufacture of the devices should conform to safety principles, taking account of the generally acknowledged state of the art,” the text states. “When risk(s) reduction is required, the manufacturer should control the risk(s) so that the residual risk associated with each hazard is judged acceptable.“
Subsequent principles zero in on standards specific to in-vitro diagnostics, devices that incorporate biological materials and software-based products. These principles are less general than the example cited above, but are similarly quiet about how to achieve compliance. For example, the section on software states these devices “should be designed to ensure repeatability, reliability and performance according to the intended use.”
Establishing such general principles for what constitutes acceptable safety and performance gives the Indian medical device sector a base to work from as it moves into a new era. That era got underway at the start of the year with the Medical Devices Rules, 2017, but is still taking form as efforts such as the essential principles and notified body scheme advance.
Final Document
Pakistan Floats Pharmacovigilance Rules, Creation of Safety Monitoring Regulatory Unit
Pakistan is planning to adopt pharmacovigilance legislation. The draft proposal places adverse event monitoring responsibilities on companies and tasks the Drug Regulatory Authority of Pakistan (DRAP) with creating a National Pharmacovigilance Centre (NPC) to oversee the sector.
The requirements set out in the draft mirror those already in place in other parts of the world. If adopted, the legislation would require manufacturers to run pharmacovigilance systems that collect, store and analyze adverse event reports and submit information to NPC. Each manufacturer will need to make a Pakistan-based employee responsible for the pharmacovigilance system on a “permanent basis.”
DRAP will also need to invest in its capabilities to meet its proposed responsibilities. NPC, working under DRAP’s division of pharmacy services, will collect adverse event reports involving approved and experimental products from healthcare professionals, sponsors and patients. If the information is incomplete, NPC staff will follow up to gather the missing details.
The goal is to ensure the reports are suitable for submission to the World Health Organization (WHO) and ultimately to establish a repository of adverse events that supports meaningful assessments of the risks and benefits of therapies.
To ensure NPC can perform its functions, the legislation states it must be provided with the necessary “technical staff, logistics and technical facility.” The legislation also specifies that NPC will acquire a national database linked to systems run by WHO and regional and provincial centers. Subscriptions to scientific literature, tools for coding adverse drug reactions and other pieces of software are on the list of enabling NPC assets drawn up by the legislation, too.
Publication of the draft legislation follows months of work by DRAP, initially under the leadership of the now-departed Dr Muhammad Aslam, and other institutions to establish a pharmacovigilance system. Media reports of a draft pharmacovigilance framework and plans to connect to WHO’s global database emerged last year. Then, in February, details of efforts to create NPC were released.
Draft Legislation
TGA Starts Review Into Ventilator Safety After Learning of Range of Issues
The Therapeutic Goods Administration (TGA) of Australia has started a review into the safety of ventilators. TGA began the review after receiving reports of a range of issues with the mechanical breathing devices, including spontaneous shutdowns and oxygen sensor malfunctions.
Officials first mentioned concerns with the safety of ventilators in a monitoring communication in June. The notice alerted users to shutdowns and other failures of ventilators used in intensive care units that could have led to deaths without the intervention of healthcare professionals. Receipt of those reports led TGA to look into national and international data on the safety of ventilators and ultimately to the review unveiled this week.
TGA has initiated the review to source information from sponsors. Specifically, the agency has asked for post-market data, justification for using the products on children, evidence products meet the instructions for use specifications and details of suitable breathing circuits.
The review is focusing on 18 ventilators commonly used to provide long-term therapy for intubated patients in hospitals. TGA may add more ventilators to the review later. The initial list includes devices sold by manufacturers including Draeger Medical, GE Healthcare, Philips and Medtronic.
The Medtronic device, the Puritan Bennett 980, is temporarily suspended owing to the “potential risk of death, serious illness or serious injury” stemming from its use. TGA thinks Medtronic can take actions to eliminate the risk before the six-month suspension is up in August. The other ventilators remain on the market and in use.
TGA Notice
Australia Suspends Clutch of LivaNova Devices Over Compliance Failures
TGA has temporarily suspended eight medical devices sold by LivaNova. The six-month suspension stems from LivaNova’s failure to comply with the inclusion requirements of the Australian Register of Therapeutic Goods (ARTG).
Each of the devices affected by the suspension is a type of cannula, thin tubes used to get fluids and medical instruments into and out of the body. TGA gave the same reason for each suspension.
“The reason for suspension was failure to comply with the conditions of inclusion related to the availability of the information demonstrating the application of the appropriate conformity assessment procedure,” TGA wrote in its explanation.
TGA is set to lift the suspension on 10 August.
ARTG Suspensions
Pakistan Orders Adoption of 2D Barcodes on Drug Packaging
Pakistan has mandated the use of 2D barcodes on drug packaging. DRAP alerted the industry to the need to add barcodes to their products after the Supreme Court ordered the implementation of the technology.
Writing at the end of February, the Supreme Court gave pharmaceutical companies three months to “implement and enforce a barcode not only on the box but also on the wrappers affixed upon the containers/bottles.” DRAP alerted the industry to the ruling and its implications in a notice sent to the chairs of trade organizations this week.
The notice orders companies with human and veterinary drugs and biologicals approved for use in Pakistan to “make necessary arrangements” to comply with the Supreme Court order in the “stipulated period of time.” Taking the Supreme Court ruling as the start date, that suggests companies have until the end of the month to comply.
DRAP Notice

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