Asia Regulatory Roundup: India Commits to Phased Overhaul of Medical Device Regulations

RoundupsRoundups | 19 February 2020 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
India Commits to Phased Overhaul of Medical Device Regulations
The Indian government has set out the timeline for moving to a new regulatory system for medical devices. Officials intend to institute a law that will increase oversight of all medical devices on 1 April but will defer enforcing the new requirements for upward of 18 months.
Last year, the Indian government published draft legislation that would see all medical devices sold in India treated as drugs for regulatory purposes. Historically, India has only subjected a fraction of the devices sold in the country to the more stringent drug regulations. The government detailed plans to expand the use of the regulations in 2018, starting initially with nebulizers, blood pressure monitors, digital thermometers and glucometers, and has since moved to bring more devices under the rules.
The rules will begin to apply to nebulizers and certain other devices in 2021 but the government is set to give the wider industry more time. In final legislation published last week, the government said devices in Class A and B, which at most pose a low moderate risk, will be exempt from the rules for 30 months. The exemption period for higher-risk Class C and D devices will last for 42 months.
Once the exemption periods end, the devices will become subject to regulations on quality, pricing and market access. The change may raise the standard of medical devices sold in India but could also force smaller companies out of the industry through the imposition of rules that they are unable to meet.
The government shared news of the transition alongside details of its plans for the registration of medical devices. On 1 April, the government plans to bring a law into force to require manufacturers of certain medical devices to register products using a portal created by the Central Drugs Standard Control Organization (CDSCO). Registration will be voluntary for the first 18 months.
To register devices, manufacturers will need to upload certificates showing their compliance with ISO 13485. Importers will need to show ISO compliance and a free sale certificate from a device’s country of origin.
Gazette Notification, More
TGA Creates Guide to Evidence Requirements for Device Authorizations
Australia’s Therapeutic Goods Administration (TGA) has published guidance to help developers of new medical devices understand the evidence to support filings for marketing authorization.
The guide covers everything from the essential principles device developers need to consider in the design and development stage through to how to compile clinical evidence ahead of a submission for marketing authorization. TGA has designed the guidance for developers of in vitro diagnostics and medical devices, including products categorized as software as a medical device (SaMD).
With TGA working to revise its position on SaMD, more developers of medical software are likely to need to be registered in the Australian Register of Therapeutic Goods and be subject to requirements placed on higher-risk devices going forward. The guide published by TGA could help such companies.
The guide covers many fundamental points that will be familiar to companies with a history of taking medical devices through the TGA authorization process. For example, the guide explains what pivotal data is and its importance to device developers. Other topics covered in the TGA guide include the difference between direct and indirect clinical evidence.
TGA Guide
India Forges Ahead With Plan to Make Marketers Responsible for Drug Quality
The Indian government has firmed up its plans to apply product quality rules to companies that sell products manufactured by third parties. Officials plan to bring the changes into force in March 2021.
Currently, manufacturers are responsible for product quality. As such, a company can source a drug from a third-party manufacturer and place it on the market without being held liable for the quality of the product. The government proposed making marketers responsible for drug quality last year, reportedly to stop large pharmaceutical companies from blaming smaller contract manufacturers for substandard products.
In finalizing the legislation, the government has retained the core stipulation that “any marketer who sells or distributes any drug shall be responsible for quality of that drug as well as other regulatory compliances along with the manufacturer under these rules.” The government has also added a new section that places further restrictions on marketers.
The new section states: “No marketer shall adopt any drug manufactured by another manufacturer for marketing of such drug by labeling or affixing his name on the label of the drug with a view for its sale and distribution.”
In some cases, marketers can gain permission to breach that rule, Marketers that want to benefit from that flexibility will need to reach an agreement with the authorities.
The changes were welcomed by the by the Organisation of Pharmaceutical Producers of India when they were originally proposed in the draft. The trade group framed the change as being in line with its view that “quality should be embedded in every stage of the medicine-making process and across the delivery chain.”
Gazette Notification
NMPA Details Inspection Activities Initiated in Response to Coronavirus
China’s National Medical Products Administration (NMPA) has shared details of the inspections it has run as part of its efforts to ensure the quality of products used to counter the coronavirus outbreak.
The inspection program is primarily intended to ensure the quality and safety of products sold for the diagnosis, prevention and treatment of the novel coronavirus COVID-19. However, NMPA’s write up of its recent inspections suggests the agency is also using its interactions with manufacturers as a way to identify opportunities for it to act to improve the response against the virus.
Specifically, inspectors in the Chinese province of Hebei learnt that the restricted supply of active pharmaceutical ingredients (APIs) was creating problems for some finished product manufacturers. According to NMPA, the inspectors are helping to expand the supply of APIs.
NMPA also provided information about the work done by its inspection teams in Jiangsu and Henan. The report identifies some of the manufacturers and products targeted by the inspectors. Ribavirin, an antiviral, and methylprednisolone sodium succinate, a corticosteroid, are among the products covered in the report. NMPA is yet to share details of the findings of its inspectors.  
NMPA Notice, More (both Chinese)
Other News:
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has outlined plans to start holding pre-submission meetings next month. NPRA will use the meetings to provide regulatory advice to applicants and, in doing so, ensure the quality of submitted dossiers and improve the evaluation of applications to register products for use in Malaysia. NPRA Presentation
TGA has updated its guidance on the standards that tablets, capsules and pills must comply with. The revised guidance features changes intended to clarify TGA’s advise on dissolution testing. The update clarifies that delayed release dosage forms may use disintegration testing to show the ingredients are released appropriately. TGA also shared details of when no dissolution test is needed. TGA Guidance
Product tests run by Malaysia’s NPRA have identified 17 ranitidine medicines that contain too much N-Nitrosodimethylamine (NDMA). The tests also identified three ranitidine medicines with levels of NDMA below the limit. NPRA is overseeing the recall of the 17 products, which include two Zantac formulations, that breached the limit. NPRA Notice (Malaysian)


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