Singapore’s HSA updates medical device Technical Specification
Singapore’s Health Sciences Authority (HSA) included secondary assembly activity guidelines in its medical device Technical Specification 01 (TS-01) in early July 2010. Manufacturers that make use of secondary assembly must meet new regulations by August 2011. HSA defines secondary assembly activity as "the process of repackaging a medical device from its original packaging into another packaging, without breach of the primary package, before the medical device is supplied." The guidelines are to maintain the quality, safety and integrity of medical devices.
If a secondary assembler is necessary, the secondary assembly organization needs to meet one of two certification requirements. In the first case, the secondary assembler can abide by regulations if it is ISO 13485 certified. In the second case, the secondary assembler can meet regulations by being Good Distribution Practice for Medical Devices (GDPMDS) (including secondary assembly) certified and making no alterations to the labels, expiration dates, or batch/lot numbers. As an exception in this case, labels can have a new quantity number.
The update includes details regarding the facility conditions, assembly documents, packaging materials, labeling, assembly equipment, and quality control. Medical devices that need to follow these guidelines include active implantable devices, anaesthetic and respiratory devices, dental devices, diagnostic and therapeutic radiation devices, electro mechanical medical devices, hospital hardware, in vitro diagnostic devices, non-active implantable devices, ophthalmic and optical devices, reusable instruments, single-use devices, and technical aids for disabled persons.
AMMI pushes for new governmental role in Malaysia’s medical device market
The Association of Malaysia Medical Industries (AMMI) is lobbying the government to change how the state affects the industry. Currently, the Malaysian government influences the medical device market by providing financial incentives for investments in R&D. AMMI, however, believes that the government should provide more support for investments in intellectual property protection and talent nurturing in the form of training programs. AMMI is also pushing for more government incentives in the form of tax cuts rather than grants.
Additionally, AMMI is developing Malaysia’s medical device industry by providing training for over 100 of the country’s medical device managers and executives. They are collaborating with the Penang Skills Development Centre. These joint training programs are to enhance the human capital in the sector. Future university graduates aiming to enter the medical device regulation field can jumpstart their career by participating in these programs.
AMMI has 24 members, including B. Braun and Ambu Inc. In recent years, AAMI’s sales made up more than half of the approximately $1 billion medical device market.
Roughly 80% of Malaysia’s medical device industry consists of imports. The country is a leader in rubber exports. It provides 80% of the world’s disposable gloves and 60% of the world’s catheters. Latest estimates indicate that the market value of Malaysia’s medical device sector will continue to experience close to 10% annual growth until 2015.
Important preparations for 2010 Chinese Pharmacopoeia implementation
The 2010 Chinese Pharmacopoeia is a new and revised version of the 2005 Chinese Pharmacopoeia. Completed in 2009, it will come into effect October 1, 2010. Manufacturers in each Chinese province are expected to adhere to the contents. One of the most time-sensitive updates is that all drug manufacturers must make any necessary changes to adhere to the Pharmacopoeia’s guidelines for specifications and labeling by October 1, 2010. This may require filing supplemental applications to the provincial FDA.
The 2010 Chinese Pharmacopoeia acts as the national legal source to ensure drug quality control, drug use safety, and drug efficacy. It also includes standards for national drug development, manufacturing, operations, use, and management. Drawing from foreign drug standards, the book includes recent innovations, developments, and evidence-based foundations.
The book is split into three volumes for traditional Chinese medicine (TCM), chemical drugs, and biological products. In total, there are 4,600 varieties of drugs covered – 1,300 of which are new. The drugs in the new National Essential Drug List and the National Medical Insurance Drug List have also been incorporated.
Updates and new information have been focused on increased safety inspection requirements and standards for high risk drugs, TCM, and drugs with heavy metal or other harmful elements.
Updated regulations on the Philippines’ drug testing laboratories
On July 19, 2010, the Philippines’ Department of Health signed Administration Ordinance No. 2010-0024. This ordinance requires a new permit (Department of Health Permit to Construct) as a part of the Free-standing Screening Drug Testing Laboratory (free-standing SDTL) Accreditation Process. This ordinance affects all such facilities – both public and private – throughout the nation. Any organization seeking to open a new free-standing SDTL, change locations, or switch owners must first acquire this Department of Health Permit to Construct.
The Philippines’ Department of Health collaborated with the Bureau of Health Facilities and Services (BHFS) to increase quality assurance of its drug testing facilities. With this new permit requirement, these regulatory bodies hope to receive sufficient information to screen, review and evaluate facility applications. To aid applicants, the BHFS included prototype details. Those looking to apply can use these as guidelines for what materials are suggested for walls/finishings and what criteria will be checked, such as ventilation and utilities.
Application for the Department of Health Permit to Construct for free-standing SDTLs requires a non-refundable fee of USD $22. The application can be accessed online on the Philippines Department of Health website.
Ames Gross is president and founder of Pacific Bridge Medical, recognized nationally and internationally as a leader in the Asian medical markets. Founded in 1988 PBM has helped hundreds of medical companies with business development and regulatory issues in Asia. Contact PBM at firstname.lastname@example.org.
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