June 8, 2018

Brazil Launches System for Monitoring Prostheses

Brazil’s Anvisa is launching a new web platform to monitor prosthetic implants. The National Registry of Implants (RNI) will register patients who have received hip and knee prostheses and coronary stents to better track data and adverse events for the implanted devices.

The registry will help generate information about implants and implanted stents, the surgical techniques used, the profile of patients and the health services involved. Data will be used to improve the regulation of implantable products as well as therapeutic practices and materials, Anvisa said.

The implementation of the registry in health services will begin with voluntary participation by several hospitals. It will gradually be opened up to include other health services and eventually it will be made compulsory, Anvisa said.

The authority plans to conduct a public consultation on a regulatory proposal relating to the new registry.

Hong Kong Updates Listing Requirements for Devicemakers

Hong Kong has clarified the roles for local manufacturers and listed importers and suppliers of medical devices.

Hong Kong’s Medical Device Control Office (MDCO) maintains a list of importers under the Medical Device Administrative Control System (MDACS) and devicemakers wanting to import and supply medical devices are encouraged to apply for listing as importers under the MDACS system.

The listed importer must have a “manned office” in Hong Kong where import operations are carried out. The listed importer should document procedures to define controls needed to identify, store, secure and retain records documenting disposition of products. The importer should retain these records for at least seven years after the projected service life of the medical device.

The listed importer is responsible for ensuring the device manufacturer maintains a quality management system that includes handling adverse events. The listed importer must also maintain records so devices can be traced and promptly withdraw from the market if necessary.

The listed manufacturer must be a local manufacturer that maintains a quality management system that complies with ISO 13485 or equivalent. The manufacturer must maintain a list of devices on the market that includes the make, model and class and brand name of the devices. Updated lists should be supplied to the MDCO every 12 months.

Read the guidance document here: www.fdanews.com/06-06-18-HongKong.pdf.

MHRA Device Expert Advisory Committee Names New Chair

The UK’s Medicines and Healthcare products Regulatory Agency’s Devices Expert Advisory Committee (DEAC) appointed Peter Groves as its new chairman.

The DEAC provides independent expert advice on a range of issues relating to medical devices to support regulatory decisions.

Groves is a consultant cardiologist at Cardiff and Vale University Health Board. He previously sat on the expert committee as a representative for Wales as a deputy chair. He is also the current chair of the NICE Medical Technology Advisory Committee.

Thailand Reclassifies Eye Products

Thailand’s Food and Drug Administration reclassified eye products and released a new guidance document to help devicemakers and importers in classifying the products.

Examples of Class I medical devices include glasses, contact lenses and lens care solutions, and examples of Class II medical devices include ophthalmic viscosurgical devices, lensmeters and emergency eye wash.