Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China’s NDA Revises Device Classification Requirements, Floats Changes to Imports
China’s National Drug Administration (NDA) has implemented a new classification system for medical devices. The new classification came into force on 1 August, moving China into a transition period that could create challenges for companies.
NDA is trying to mitigate these challenges. The agency has published a table to connect the new classification catalogue to the old system, and shared advice with manufacturers of devices affected by the changes.
Manufacturers of devices that have been recategorized do not need to do anything immediately, but should file under their new category when they come to renew their expiring registration certificates. NDA has created a regulatory group to help companies that encounter problems in implementing the new catalogue.
The text on the implementation of the classification catalogue was one of three device documents published by NDA in quick succession. One of the other documents covers information management, including the impact of the new classification catalogue. Other sections of the information document detail the data recording and disclosure obligations of medical device manufacturers.
Finally, NDA also published a draft document on the supervision of imported medical devices. NDA is accepting feedback on the draft until 2 September.
, Information Rules
, Import Draft
Pakistan Changes Draft Ethical Marketing Rules, Moves to Pass Legislation
Pakistan has published draft rules on ethical marketing to healthcare professionals. The document will give the Drug Regulatory Authority of Pakistan (DRAP) the power to act against companies that seek to influence healthcare professionals through payments, gifts and other means.
The draft now advancing toward finalization covers many of the same points as the document
posted late last year, but Pakistani officials have made some significant changes during the revision process. Notably, the latest text empowers Pakistani authorities to go into companies and look for evidence of compliance breaches.
“To ascertain breach of these rules, authority shall have the power to be carry out financial audit of any healthcare industry, either itself or through any external auditor appointed for the purpose,” the latest draft states.
The potential penalties for people found to have breached the code are severe. As in the earlier draft, the punishment section of the latest text refers to two schedules of the DRAP Act 2012. These schedules permit the life imprisonment of people who break some laws twice, plus a range of shorter fines and sentences for lesser crimes.
On paper, the revised text gives DRAP and the rest of the Pakistani state more power to identify and investigate wrongdoing, but in practice voluntary compliance is likely to remain important. The rules list multiple internal steps companies must take to ensure their practices are ethical.
The latest text is still in draft form but has already come through one consultation mostly intact. The industry now has 15 days to submit any final feedback to DRAP before the rules come into force.
India Tweaks Rules on Submission of IVD Performance Evaluation Reports
India has changed its rules on in-vitro
diagnostics (IVDs). The revisions to the Medical Devices Rules, 2017, provide additional details about when applicants must provide a performance evaluation report for their IVDs.
When officials published the rules in the Gazette of India last year, performance evaluation reports issued by medical device testing laboratories were listed among the materials required in filings for licenses to import or manufacture Class B, C or D medical devices. The revised text expands on that briefly stated requirement.
Now, the text states a “performance evaluation report by the manufacturer shall be submitted by the applicant,” before going on to detail provisions related to the requirements of state licensing authorities and list other organizations that can issue the report.
DCGI Orders Regulators to Enforce Rules on Oxytocin Production and Importation
The Drug Controller General of India (DCGI) has told regulatory officials to “keep strict vigil” to ensure incoming rules on oxytocin are enforced. DCGI Dr. Eswara Reddy wants staff at all regulatory outposts in India to help finally put a stop to the misuse of the hormone by farmers.
A delay to the implementation of the rules means restrictions on the production of oxytocin will not come into force until the start of September. Ahead of that day, Reddy has written to staff at the Central Drugs Standard Control Organization (CDSCO) to remind them of the content of the rules and request their enforcement.
Reddy sent three near-identical letters to CDSCO’s port offices, zonal and sub-zonal offices and to all state drug controllers. The main difference is the letter to the port offices focuses on the importance of stopping the importation of oxytocin, while the other letters cover enforcement activities related to the production, distribution and sale of the hormone.
DCGI needs the offices to enforce the rules effectively if the latest attempt to stop oxytocin misuse is to be more successful than earlier efforts, which failed to fully wipe out the agricultural practice.
Doctors Concerns Put TGA Regulation of Mobile Apps in Spotlight
An academic paper has raised concerns with how the Therapeutic Goods Administration (TGA) of Australia regulates mobile medical apps. The publication of the paper led TGA to state it is preparing to seek feedback on planned regulatory reforms similar to those recently implemented in Europe.
TGA classes apps that diagnose, prevent, monitor or treat disease as medical devices. Some apps, by accident or design, avoid the regulations that come with being classed as a medical device. If an app is regulated, it will typically be categorized as a Class I device. This is the case for apps designed to calculate insulin doses.
Some doctors have concerns about treating dose calculators as Class I devices. Writing in The Medical Journal of Australia
, Rahul Barmanray and Esther Briganti state “physicians cannot be sure of relying on insulin dosing recommendations made by a glycaemic control app ... as it did not even require a conformity assessment.”
Barmanray and Briganti think greater oversight is needed to prevent apps from compromising clinical care. TGA, taking its lead from the European Medicine Agency, is working on reforms that could address these concerns.
“The new rules [in Europe] capture decision making software like dosage calculators. [These] apps will now be a higher classification requiring third-party certification,” a TGA spokesperson told MJA InSight
. “Australia is preparing to undertake consultation for similar regulatory reforms.”
, MJA InSight
The Medical Imaging and Technology Alliance
(MITA) has submitted feedback on China
’s proposed regulations for the supervision and administration of medical devices. MITA’s comments highlight areas in which the regulations deviate from international norms. For example, MITA wants China’s NDA to drop plans to require manufacturers to submit self-audit reports because other regulators do not demand such detailed documents. MITA Comments
The Ministry of Food and Drug Safety
(MFDS) of South Korea
has published English-language versions of three medical device documents. The regulatory texts cover the production of customized medical devices using 3D printers, as well as standards and specifications for biological safety and other matters. MFDS Regulations
has updated its guidance on tampons to reflect their exemption from rules requiring manufacturers of medical devices to register their products in the Australian Register of Therapeutic Goods. TGA Guidance