Asia-Pacific Roundup: Singapore seeks feedback on planned unique device identification system

Singapore’s Health Sciences Authority (HSA) is seeking feedback on the regulatory requirements for the planned implementation of a unique device identification (UDI) system. HSA wants to establish a harmonized identification system to enable the traceability of medical devices.
 
Today, HSA lacks the means to track the distribution and use of medical devices across the supply chain and healthcare system. HSA wants to gain that power to support the timely identification of patients and medical devices impacted by recalls, faults and adverse events, leading it to start work on a system that aligns with the International Medical Device Regulators Forum’s (IMDRF) principles.
 
Following the path set out by IMDRF, the Singaporean regulatory agency plans to develop UDIs based on globally harmonized standards and put the identifiers on “device package labels of the smallest unit of supply and on all higher levels of packaging” in both human readable interpretation and Automated Identification for Data Capture formats, such as a barcode. UDIs applied to meet the requirements of the U.S. and European Union markets will be accepted.
 
Players in the supply chain will need to upload UDI information into the Singapore Medical Device Register and Class A Medical Device Database. HSA said the databases capture “most of the essential information on the medical devices” such as brand name, model identifier, intended use and name of product owner. As such, “Only certain minimum necessary UDI data elements will be required to be included to supplement the existing information.” HSA is developing a service to allow up to 30 device registrations to be submitted in a single application without a change notification filing.
 
The guidance is open for consultation until 30 June.
 
HSA Notice, Consultation Document
 
TGA proposes changes to human cell and tissue product standards
 
Australia’s Therapeutic Goods Administration (TGA) is holding a consultation on the regulation of human cell and tissue (HCT) products, blood and blood components. TGA said existing policies work “largely effectively and efficiently” but could be improved with more international harmonization.
 
With the existing HCT legislative instruments set to sunset in October, TGA is taking the opportunity to review and tweak the policies. The process has led TGA to identify points that can be clarified and chances to boost efficiency through international harmonization.
 
In making the changes, TGA plans to combine the four current product-specific standards into a single document. The new, merged order will also cover microbiological and critical materials requirements that are currently addressed in the document on donor screening requirements, and will extend some general manufacturing requirements to all biologicals.
 
The other two current therapeutic goods orders will remain standalone documents but will undergo some changes. TGA plans to change the labeling order to allow the use of machine-readable codes and impose additional labelling requirements for Class 3 and 4 biologicals. The revised order on donor screening will exempt autologous HCT products and exempt directed allogeneic HCT products from donor deferral criteria.
 
TGA is seeking feedback on the planned changes until 11 July. The new legislative instruments have a commencement date of 30 September, although TGA said a “transition period will be introduced where necessary and based on the outcomes of consultation.”
 
TGA Consultation, TGA Notice
 
China publishes guidance on inspections of pharma facilities
 
China’s National Medical Products Administration (NMPA) has released guidance on the inspection of pharmaceutical facilities. The guidance describes the different types of inspections performed by the Chinese authorities and the procedures for visiting facilities.
 
In the section on inspection procedures, the longest chapter in the document, NMPA states that inspection teams should typically consist of two or more inspectors and create a plan before going to a facility in person. The team should perform the inspection strictly in accordance with the plan. If the inspectors find a quality or safety risk, they must immediately report the problem. A decision on whether to suspend production or take other enforcement actions will be made within three days.
 
Other sections of the guidance address the specific requirements of different types of inspection, such as licensing assessments and for-cause visits. The section on for-cause inspections explains when they take place, for example because of the receipt of a complaint about a quality or safety risk, and how their preparation and execution differs from other types of regulatory assessments.
 
The guidance also details the process for handling the discovery of suspected illegal activities. In that scenario, personnel should immediately investigate and obtain evidence, and the inspection team should immediately report to their management. The drug supervision department will then send investigators to the inspection site to collect physical evidence such as hard drives.
 
NMPA brought the guidance into effect upon its publication.
 
NMPA Notice
 
Pakistan starts consultation on handling rapid alerts and recalls
 
The Drug Regulatory Authority of Pakistan (DRAP) has released draft guidance on rapid alerts and recalls arising from quality defects for consultation. DRAP created the document to explain and standardize the procedure for classification and communications involved in a product recall.
 
In creating the guidance, DRAP drew on two Pharmaceutical Inspection Co-operation Scheme (PIC/S) documents that cover good manufacturing practices for medicinal products and the procedure for handling rapid alerts and recalls arising from quality defects.
 
The DRAP guidance uses the three-tier classification of recall severity established in PIC/S guidance, and also takes processes such as the rapid alert contact list and target timelines from the harmonized global documents.
 
DRAP said the guidance is applicable to human and veterinary products “with established quality defects reports” and to all “incidents of safety and efficacy received for all therapeutic goods for which a market action is required.” The regulatory agency expects all manufacturers, importers, distributors and retailers to follow the guidance.
 
DRAP is accepting feedback on the draft until 17 June.
 
DRAP Guidelines
 
Malaysia clarifies rules on supply of medical devices intended for professional use
 
Malaysia’s Medical Device Authority (MDA) has published a statement on the distribution and supply of medical devices intended for professional use. The statement explains that such tests are intended for use by qualified and trained medical professionals.
 
Regulators such as the UK Medicines and Healthcare products Regulatory Agency have heard of cases of professional-use COVID-19 tests being offered for self-testing. The MDA notice lacks details about why it is clarifying the rules but is clear on why the agency is opposed to the distribution of in vitro diagnostics to the public.
 
“Distribution of this medical device to general public is strictly prohibited. The use of medical device intended for professional use by the public may increase the risk associated to it due to the lack of qualification and knowledge in the use of the medical device and subsequent management of a disease,” MDA wrote.
 
MDA is monitoring the promotion of medical devices, including online, for evidence that products intended for professional use are being sold to the public. The agency also wants the public to be alert to the possibility that retailers may promote professional-use devices and to report any potential violations of the rules.
 
MDA Notice
 
Other News:
 
China’s NMPA has published details of the medical device standards it plans to develop and revise. NMPA solicited objections to the plan from May 26 to June 1. NMPA Notice (Chinese)