In Canada, Medical Device Single Audit Program (MDSAP) is a mandatory requirement for Class II, III, and IV medical devices. Only with MDSAP certificate can you apply for Medical Device Licence (MDL) for Class II, III, and IV medical devices. Health Canada accepts a...
CDSCO medical device labelling guidelines in India is governed by the Medical Devices Rules, 2017. These labelling guidelines help healthcare providers and patients identify and use devices correctly, reducing risks of misuse or counterfeit products. They also...
Planning to start a disposable medical devices manufacturing business in India? Well, you have landed in the right place. This blog has got you covered from potential for the business to CDSCO license required. Potential for starting a disposable medical devices...
Legacy IVD devices are IVDs legally CE-marked under the old EU In Vitro Diagnostic Directive (IVDD). They were CE marked before the EU In Vitro Diagnostic Regulation (IVDR) took effect. They are allowed to remain in the market during a defined transition period if...
Surgical bandages are low-risk non-invasive medical devices that do not directly sustain or support life. Additionally, their potential harm to patients is minimal. They are primarily used for external wound protection and healing. Hence, they are placed under limited...
Medical examination gloves play a vital role in the healthcare industry. They serve as a protective barrier that prevents the transmission of infections between patients and healthcare workers. Gloves also protect healthcare professionals from occupational hazards in...