Medical Device Regulatory Compliance

At MDD, we are proud to collaborate with MVM Company Limited to bring unparalleled expertise to manufacturers navigating Hong Kong’s complex regulatory landscape. Together, we ensure that your medical devices meet all regulatory requirements while maintaining the highest standards of safety and quality.

As a premier regulatory affairs company, MVM Company Limited is dedicated to supporting medical device manufacturers in complying with Hong Kong’s stringent regulations. Acting as a Local Responsible Person (LRP), MVM specializes in registering and listing medical devices with the Medical Device Division of the Department of Health, providing end-to-end compliance solutions tailored to your needs.

Comprehensive Services

MVM’s regulatory services include:

• Medical Device Registration: Expert guidance through the registration and listing process to ensure full compliance.

• Post-Market Compliance Management: Support in monitoring and maintaining compliance after market entry.

• Adverse Event Reporting: Assistance in reporting and addressing any adverse events efficiently.

• Product Recalls: Professional handling of product recalls to safeguard public safety and your brand’s reputation.

Expert Team

MVM’s team comprises highly trained professionals with diverse backgrounds in regulatory, medical, and legal fields. This multidisciplinary expertise enables us to:

• Bridge the gap between manufacturers and stakeholders, including healthcare professionals, hospitals, and other institutions.

• Provide insightful, actionable solutions that cater to both local and international standards.

• Ensure your products meet the regulatory requirements without compromising safety or quality.