Monthly Archives: June 2017

Earlier this month, the U.S Food and Drug Administration (FDA) released a statement on their attempt to regulate digital health devices by eliminating regulatory ambiguity, driving innovation, and freeing up regulators to focus on more important matters. The new Digital Health Innovation Plan focuses on advancing innovation at the intersection of medicine and digital health technology.

According to FDA Commissioner Scott Gottlieb’s blogpost, “Congress has already taken a major step to advance these goals in the 21st Century Cures Act. Expanding upon policies advanced by the  FDA’s Center for Devices and Radiological Health (CDRH), the Act revised the FDA’s governing statute to, among other things, make clear that certain digital health technologies—such as clinical administrative support software and mobile apps that are intended only for maintaining or encouraging a healthy lifestyle—generally fall outside the scope of FDA regulation. Such technologies tend to pose low risk to patients but can provide great value to the healthcare system. The FDA, led by CDRH, is working to implement the digital health provisions of the 21st Century Cures Act and, in the coming months, will be publishing guidance to further clarify what falls outside the scope of FDA regulation and to explain how the new statutory provisions affect pre-existing FDA policies”.

The Digital Health Innovation Plan aims to create a more efficient and risk-based approach to the regulation of digital health devices. The FDA is currently developing a pilot program that considers the involvement of a third-party certification program, under which lower-risk digital health devices could be marketed without FDA pre-market review, while higher risk products could be marketed with a streamlined FDA pre-market review.

Gottlieb added, “the FDA will provide guidance to clarify our position on products that contain multiple software functions, where some fall outside the scope of FDA regulation, but others do not. In addition, the FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that the FDA does not intend to subject them to certain pre-market regulatory requirements.”

This new plan will be the initial step to a broader effort that enables the FDA to offer an efficient regulatory approach for new low-risk digital health device technology in the healthcare industry. This will expedite the regulatory process in this field and facilitate the rapid innovation of promising, safe, and effective digital health devices.

Previously, the importation into Indonesia of any medical device classified as “for Research-Use Only (RUO)” was a time-consuming process. The importation process for RUO devices required an official statement letter from the Ministry of Health of Indonesia. This letter was called the “Special Access Scheme (SAS) letter for Research purposes” and it required the following: the research team members list; the research or clinical trial protocol; and, ethical clearance for research from a national teaching hospital.

The Ministry of Health of Indonesia has issued a new regulation that came into effect in June 2017, which replaces the “Special Access Scheme (SAS) letter for Research purposes” with the “Research-Use Only (RUO) statement letter“. In order to apply for this letter, the following information must be provided:

• An application letter
• Executive summary and instructions for use of the device
• Brochure, catalogue, or other supportive document
• RUO device certificate from the country of origin
• RUO labelling
• Statement letter of research-use only and non-clinical purpose from the manufacturer

The requirements for the RUO statement letter are much easier to obtain and the process is more convenient overall. Henceforth, clinical trial information will not need to be provided, thus speeding up the importation process of RUO devices. The general purpose of this regulatory update is to encourage and support national researchers and health providers by increasing access to RUO devices. This will hopefully encourage more clinical research to be undertaken in Indonesia.

The Department of Medical Device Registration within the China Food and Drug Administration (CFDA) oversees the overall safety and efficacy of medical devices within the country. The “Regulations for the Supervision and Administration of Medical Devices (2000)” and the “Measures for the Administration of Medical Device Registration (2004)” are the two main regulations, describing the legal requirements for obtaining medical device approval in China. Within these guidelines, medical devices under Class I do not require local clinical testing, while those under Class II & III do require clinical trials, unless they are on the CFDA’s clinical trial exemption list.

In May 2017, the CFDA published a draft list of Class II & III Medical Devices that are exempt from CFDA clinical trial requirements. The exempt devices include:

Class II Devices

• Dental instruments and materials (e.g. dental needles)
• Endoscopic surgical instruments
• Insulin pen injectors
• Gynecology devices (e.g. uterine manipulators)
• Electronic endoscopic image processor

Class III Devices

• Orthopedic devices including bone screws, bone cements, titanium acetabular cups, medullary plug and fracture plates (3D printed devices are NOT included in the exemption list)
• Needleless connector for indwelling catheter

It is worth noting that, having a device that has the same classification as a device on the exemption list doesn’t guarantee that it is exempt from clinical trials and there may be additional criteria that need to be fulfilled. Likewise, a clinical trial may not be necessary if similar devices have been on the market for a long time and are supported by safety records with no reports of serious adverse events. The  latest medical device exemptions for local clinical trial testing took effect in September 2016. If this draft proceeds well, this will be the third edition of the exemption list to be issued by the Health Authority.

Looking Forward:
This notification will ease the way for foreign manufacturers to invest in the country’s medical device industry. This substantial move promises to dramatically curtail the CFDA’s regulatory approval times and its registration costs because the listed devices no longer have to satisfy the strict clinical trial requirements in order to enter the Chinese market. With the streamlining of device approvals, the local government aims to encourage local device innovation to satisfy the growing demand for healthcare in the country.

Telehealth is emerging as one of the essential components in the modern healthcare industry. Telehealth refers to the use of information technology and telecommunication technology to support long-distance public health management and health administration. The development of telehealth has contributed to a paradigm shift in current healthcare systems, enabling cost-effective improvements in healthcare outcomes

Some major advantages that telehealth offers include:

• It increases accessibility to healthcare for remote patients/hospitals. Patients with chronic illness can be monitored remotely or via online consultation with a physician
• It improves health outcomes by enabling efficient use of limited healthcare resources and infrastructure. This may help in earlier disease detection, reduced complications, and improved overall patient health
• It reduces healthcare costs

With the current definition of “medical devices” in most countries in the ASEAN region, the majority of telehealth products (e.g.mobile software application etc) will be fall under the scope of medical device regulatory control. Depending on the intended purpose of the product, the devices may be categorised as medical devices.

In Sep 2016, the HSA Singapore proposed regulatory guidelines on telehealth devices. Public consultation has been completed and comments from diverse stakeholders have been received. A review of the comments is progressing, and it is anticipated that the guidelines will be updated over the coming months. Looking forward, it is anticipated that telehealth will grow in leaps and bounds. Let us keep you updated on the fast-paced regulatory changes in this field!