Introduction India is one of the largest medical device markets globally and therefore needs a robust system for the regulation of medical devices. At present only a few medical devices in India are regulated as drugs under the Drugs and…
Following amendments to Brazil’s rules for Good Manufacturing Practice (GMP) certification, certain international products will be able to benefit from risk assessments, including reviews of technical documentation, rather than on-site GMP inspections1. The changes to Resolution RDC No 39/2013, which…
The Therapeutic Goods (Manufacturing Principles) Determination 20181 came into effect on 1 January 2018 and specifies the manufacturing principles that apply to specific therapeutic goods as set out in three Divisions: Division 1 – therapeutic goods including Active Pharmaceutical Ingredients and…
Resolution RDC No 183 concerning the Good Manufacturing Practice (GMP) certification of foreign medical device manufacturers was published in the Brazilian Official Journal on 19 October 20171. This Resolution sets out the inspection programmes and administrative procedures that apply with…
Regulatory authority Singapore’s healthcare regulatory framework consists primarily of: the regulator, which is the Ministry of Health along with its statutory boards; and the regulated, which are the public and private healthcare providers. Medical devices are regulated under the Health…
Brazil is a large country with extensive and constantly expanding medical device regulations. This report explores the changes that are likely to have the greatest impact on companies’ regulatory strategies during 2018. Firstly, it sets out the official regulatory agenda…
The Saudi Food and Drug Authority has finalised and published eight new guidance documents relating to medical devices1: MDS-G7, Guidance on Medical Devices Bundling Criteria; MDS-G12, Guidance on Importation Requirements for Chemicals Used in Medical Devices Applications; MDS-G13, Guidance for…
ANVISA, the National Health Surveillance Agency in Brazil, has announced that it will accept confidential information on inspections received under agreements or covenants with health authorities of other countries1. The granting of Good Manufacturing Practice certification may now occur upon…
