Asia-Pacific Regulatory Roundup: India permits export of some PPE, diagnostic kits

RoundupsRoundups | 04 August 2020 |  By 

India’s Directorate General of Foreign Trade (DGFT) has relaxed restrictions on the export of personal protective equipment (PPE) and diagnostic kits imposed in response to the coronavirus outbreak and will authorize successful applicants to ship set amounts of the products to other countries.
As the COVID-19 pandemic spread around the world, DGFT stopped Indian manufacturers from exporting PPE and other needed products. DGFT has begun trying to partly lift the restrictions by introducing monthly quotas of products that companies can export. That process gathered pace last week.
Under a new quota system, companies can apply to export some of the 4 million medical goggles in August and September. DGFT has set the August export quota for two- and three-ply  surgical masks at 40 million units. All restrictions on the export of face shields also are lifted.
In a separate notice, DGFT announced a quota system for diagnostic kits. A total of 23.8 million kits of viral transport media now can be exported; viral transport media has been subject to supply constraints in the United States. DGFT also is permitting the export of smaller numbers of RNA extraction kits and RT-PCR kits.
Manufacturers interested in exporting the diagnostic kits and PPE need to apply online this week. Applicants should submit materials, including a copy of a purchase order. Companies that want to export diagnostic kits also need to submit a letter, signed by the authorized signatory, to certify that they have fulfilled all domestic orders.
The application process has held up DGFT’s efforts to permit the export of other products. In June, DGFT established a quota system to facilitate the export of up to 5 million medical coveralls a month. However, none of the applicants met DGFT’s requirements, leading the trade body to issue a new call for companies interested in the product.
DGFT Notice, More
TGA advises on 3D-printed device risks
While there are advantages to using 3D printers to make medical devices, “there are also specific risks that arise that must be documented and reduced as much as possible by manufacturers,” according to Australia’s Therapeutic Goods Administration TGA), which has issued guidance to help manufacturers deliver compliant 3-D printed medical devices.
The guidance states that manufacturers must be able to show how they have mitigated any risks associated with the production of their medical devices and how products comply with relevant essential principles.
One of TGA’s concerns is that “differences in material properties and processing requirements between 3-D printing and conventional manufacturing methods mean that new risks may be introduced to patients or users, even when the same device design is being manufactured.” That makes material selection important. TGA wants companies to ensure materials are suitable for the manufacturing process and the intended use of the device.
The guidance also covers the cleaning and sterilization of 3D-printed devices. TGA wants companies that make devices that need to be sterile to follow its guidance on appropriate standards for use in validation and routine control of sterilization processes.
TGA Notice
Pakistan clears multinationals to print device labels locally
The Drug Regulatory Authority of Pakistan (DRAP) has authorized Johnson & Johnson, Medtronic and Roche to print medical device labels locally. DRAP’s action exempts the companies from some of the requirements imposed by Pakistan’s Medical Devices Rules (MDR), 2017.
MDR mandates that medical devices must be “appropriately labeled” before being introduced to the Pakistani market. The requirement poses certain problems for large multinational companies, as DRAP’s Medical Device Board (MDB) said in meeting minutes describing its assessment of an exemption request from Medtronic.
“Products are manufactured and packed for global sales so it is practically impossible to print Pakistan's local regulatory requirements. The demand/use of various devices imported to Pakistan varies both in terms of sizes and quantities hence making Pakistan specific printing difficult at the scattered manufacturing sites,” MDB wrote in the meeting minutes.
MDR permits importers to seek permission to print the required information at their licensed sites in Pakistan. J&J, Medtronic and Roche recently secured that permission, clearing them to use inkjet printers to add the required information to the inner and outer packaging of their devices. The MDB authorizations last for one year.
Meeting Minutes
Philippine FDA proposes accelerated review of prequalified products
The Philippine Food and Drug Administration (FDA) is planning to accelerate the review of drugs and vaccines that have been prequalified by the World Health Organization (WHO). FDA plans to establish the fast track by adopting a WHO annex on the accelerated registration of prequalified products.
The annex describes a process for the collaborative assessment of prequalified products by WHO and national regulatory authorities. In practice, that means WHO, with the agreement of the applicant, shares the full outcomes of prequalification assessments, inspections and, if relevant, the findings of laboratory tests with the national regulator to inform an accelerated review.
FDA said collaboration with WHO is necessary “given the current resource constraints affecting drug regulation” but is yet to flesh out all of the details. To date, FDA has only issued a brief draft order outlining its plan to adopt the WHO annex. Exactly how FDA will implement the order will become clearer when the regulator develops planned guidelines on the topic.
FDA is seeking feedback on the draft proposal until 14 August.
Draft Order, FDA Notice
TGA plans to resume attendance of in-person events in October
TGA is planning to resume its participation in in-person conferences in October. The regulator, which last attended a physical event in mid-May, has two conferences in Sydney in its calendar for October. 
With organizers of physical conferences deferring their events or moving them online in response to the pandemic, it is now almost five months since TGA participated in anything other than webinars. That is set to change in October when TGA is scheduled to participate in exhibitions involving the complementary medicine and cosmetics industries.
The state of the outbreak in Australia will dictate whether the events go ahead. Over the past week, the state of New South Wales, where Sydney is located, recorded 92 new cases of COVID-19. That represents a 24% week-on-week increase but for now the numbers are small compared to other countries and parts of Australia. The state of Victoria reported 429 daily cases on Monday.
TGA Notice
Other News:
TGA has published guidance on specimen collection swabs: Swabs must be added to the Australian Register of Therapeutic Goods before being distributed in the country. TGA has also offered advice about the classification of collection swabs and the 3D printing of the devices, notably in relation to concerns about the brittleness of such products. TGA Notice


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