Global push in med-tech innovation prompts regulatory reviews and upgrades

In country after country, regulatory review and change in the med-tech industry have become a constant. Authorities are “advancing with the changing health care landscape,” as one industry representative put it, striking an upbeat note on recent regulatory updates around the world.

In China, authorities seek to streamline reviews and approvals to drive innovation and bring devices more rapidly to market. In Australia, the industry is hailing new rules around direct-to-consumer device advertising. In Singapore, device makers will no longer need to register class A sterile devices. And in the India, the very definition of “medical device” is widening to include a range of electronic medical equipment.

This article features excerpts from a collection of recent regulatory updates from BioWorld MedTech, the daily medical device and diagnostics news service from Clarivate Analytics.

 

China updates regulations to spur domestic innovation

China has published the amended draft of administrative regulations for medical devices with the purpose of speeding up domestic innovation and bringing innovative products to China faster by streamlining the review and approval process.

Some of the significant changes of the regulations include allowing medical device developers to seek contract manufacturers, relaxing the requirements for clinical evaluation and clinical trials, and expediting approval of medical devices.

The amendment is made to address the inconsistency in the current laws and regulations, address the urgent regulation issues, and to clarify the responsibility and legal liability for legal entities in the medical device industry.”
– Grace Palma, CEO of consultancy firm China Med Device, as told to BioWorld MedTech

To read the full article, download our August 2018 MedTech update here.

 

Advert regs get upgrade down under

In Australia, meanwhile, industry welcomed changes to Australia’s regulations for direct-to-consumer (DTC) advertisements for medical devices, complementary medicines and over-the-counter medicines.

Australia’s Therapeutic Goods Administration (TGA) is not changing arrangements for prescription medicines as these are not allowed to be advertised to the public in Australia.

There are currently no restrictions on device advertising not being directed to the public; however, the types of devices advertised to the public are mainly class I devices.”
– Kay McNiece, TGA Spokeswoman, as told to BioWorld MedTech

Implantable and higher risk devices tend only to be advertised to health care practitioners in the same way that advertising for prescription drugs is directed to doctors.

The advertising changes are part of larger regulatory reforms being implemented to increase the pathways for marketing approval for drugs and devices while reducing regulatory red tape and redundancies.

To read the full article, download our August 2018 MedTech update here.

 

Giving stakeholders ‘easier access to the market’ in Singapore

Singapore’s Health Sciences Authority (HSA) made some changes to its regulatory controls for medical devices to speed up access to markets. The HSA ruled that device makers will no longer need to register class A sterile devices. “Sterile medical devices under the class A category are low risk items, ranging from sterile intravenous sets to examination gloves,” an HSA officer told BioWorld MedTech.

Instead, manufacturers will only need to list all their class A medical devices on the agency’s online class A database and comply with post-market surveillance requirements. The officer said that this is to facilitate faster and more effective entry of medical devices in the local market.

“It’s a review of the regulatory framework to give stakeholders easier access to the market with immediate entry,” the officer said.

To read the full article, download our August 2018 MedTech update here.

 

A ‘positive move’ on expanding device categories in India

At the recent meeting of India’s Drugs Technical Advisory Board, the regulators agreed to place certain medical electronic equipment under the purview of Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 as medical devices.

This move puts medical electronic equipment including all implantable medical devices, CT scan equipment, MRI equipment, defibrillators, dialysis machines, PET equipment and X-ray machines under the regulation of medical devices. They will also be subject to being placed under price caps in this category.

Rajiv Nath, forum coordinator for the Association of Indian Medical Device Industry India (AiMeD), hailed this recent development as a “positive move.”

This is especially important to restrict import of pre-owned medical equipment and address patient safety concerns of lack of calibration for accuracy and radiation.”
– Rajiv Nath, forum coordinator for the Association of Indian Medical Device Industry India (AiMeD), as told to BioWorld MedTech

To read the full article, download our August 2018 MedTech update here.

 

This article was excerpted from a new compilation of regulatory updates written by BioWorld MedTech Staff Writers Elise Mak and David Ho, based in Hong Kong, and Tamra Sami, based in Perth, Australia. BioWorld MedTech is the global news service providing med-tech updates and analysis from Clarivate Analytics. To access the full report, please click here.

For more information about BioWorld MedTech and to learn how you can subscribe today, visit: Clarivate.com/products/bioworld-medtech.