Medical Device Registration in Singapore: HSA Approval Process

Medical Device Registration in Singapore: HSA Approval Process

Singapore is one of the most regulated and strategically important medical device markets in Southeast Asia. All medical devices must be registered

Read More
Importers and Manufacturers in Medical Device Rules

Roles of Importers and Manufacturers in Medical Device Rules, 2017

The CDSCO created the Medical Device Regulations, 2017, under the Drugs and Cosmetics Act of 1940 to make sure that medical goods

Read More
ISO 13485 Certification for Medical Device Manufacturers

How to Get ISO 13485 Certification for Medical Device Manufacturers?

The ISO 13485 Certification for Medical Device Manufacturers is an internationally recognised standard that defines the quality management system (QMS) requirements for

Read More
CDSCO Import License for Class B

CDSCO Import License for Class B Medical Devices in India

Medical devices like blood pressure monitors, suction pumps, and infusion sets are categorized as Class B devices under Indian regulations. To import

Read More
US FDA 510(k) Clearance for Medical Devices

Step-by-Step Guide to US FDA 510(k) Clearance for Medical Devices

If you wish to sell a medical device in the U.S., one of the most common routes is the US FDA 510(k)

Read More
Top 10 Countries for Medical Device Exports

Top 10 Countries for Medical Device Exports

Medical devices are a major global trade category – from syringes and surgical instruments to imaging machines and implantable devices. Knowing which

Read More
EU MDR 2017/745 vs India MDR 2017

EU MDR 2017/745 vs India MDR 2017

The EU MDR 2017/745 vs India MDR 2017 comparison is an important topic for global medical device manufacturers who plan to market

Read More
Cosmetic Import License in Canada – Health Canada Guidelines

Cosmetic Import License in Canada – Health Canada Guidelines

The Challenges in the FMCG Sector have grown over the years, especially for brands dealing with cosmetics and personal care products. Importing

Read More

Drug Registration in Brazil: Decoding ANVISA’s Regulatory

Registering drugs in Brazil means getting approval from ANVISA’s Regulatory (Agência Nacional de Vigilância Sanitária) so that a medicine can be legally

Read More
Brazil ANVISA Medical and IVD Device Registration

Brazil ANVISA Medical and IVD Device Registration

Brazil ANVISA Medical and IVD Device Registration explains how manufacturers and importers get legal approval to sell medical devices and in-vitro diagnostics

Read More