• 2022-03-28 07:46:30

In the last decade, 3D printing has had a profound impact on the medical device sector. When the COVID-19 pandemic hit, this technology was lauded for its ability to adapt new designs and the speed with which it could produce the necessary commodities. Medical 3D-printed gadgets have a bright future, and we will go through the latest advances and how regulatory bodies across the world are keeping up with this development.

• 2022-03-25 11:58:47

The US Food and Drug Administration (FDA) has updated several regulations affecting De Novo classification of novel medical devices. The main purpose is to present an objective and balance for the scientific evidence to be the foundation to grant a De Novo request. Also, the De Novo products will serve as future predicate devices for prospective 510(k) registration applications to improve and extend the existing 510(k) database.

• 2022-03-25 11:56:37

Recently, TFDA has announced an update in the Quality Management System (QMS) application required documents for manufacturers in the US, Puerto Rico, or Guam. Considering the establishment inspection timeline, for manufacturers without EIR within 3 years, audit report issued under MDSAP could be provided instead.

• 2022-03-25 11:51:14

Software as Medical Device (SaMD) is rapidly developing and frequently updating its compatible hardware. In order to ensure the safety, performance, and quality of SaMD while keeping in line with international standards, TFDA has released a guideline regarding post-market change application of SaMD.

• 2022-03-25 11:49:26

The Medical Device Authority (MDA) produced this new Guidance Document to assist the medical device industry and healthcare practitioners in complying with the Medical Device Act (Act 737) and its regulations.

• 2022-03-25 11:13:53

The Indonesia Halal Assurance Agency has published the Ministry of Religion Decree No.1360/2021 on the Materials Exempted from the Obligation of Halal Certification on their official website. The regulation contains an extensive list of materials exempted and serves as guidance for the regulatory bodies.

• 2022-03-25 10:41:47

Indonesia's MoH has announced the integration of their licensing system: REGALKES with OSS RBA (Online Single Submission Risk-Based Approach) for new applications of marketing permit and their plans on integrating more licensing services with OSS RBA.

• 2022-03-25 10:38:56

Starting from February 2022, the Indonesia Ministry of Health is accepting product listing of medical devices and other health equipment for their sectoral e-catalogue for health facilities.

• 2022-03-25 10:32:01

This guideline applies to medical devices including in vitro diagnostic reagents applying for registration or filing with NMPA in China. This guideline only provides general requirements for the format and content of the product technical requirements (PTR) for medical devices and does not specify specific requirements for certain products.

• 2022-03-25 10:23:24

In December 2018, TGA has announced that there will be an adjustment of Surgical Mesh Devices to transform from medium risk (Class IIb) to high-risk devices (Class III), in order to meet the highest levels of safety, quality and clinical performance.
Sponsors were given three years to comply with the changes, and from 1 December 2021 onwards TGA has already commenced on cancelling surgical mesh devices in the ARTG as Class IIb entries, who do not have obtained an appropriate conformity assessment certificate for Class III devices prior to the set deadline, or within six months of the conformity assessment certificate for the Class III device being issued.
TGA has listed out 3 different tables, categorising meshes that are eligible for transition, approved surgical mesh devices, and existing Class III surgical mesh devices. This is to inform medical practitioners and hospitals of potential supply disruption of some surgical mesh devices from 1st December 2021, and to provide alternative sources of supply.