Loading...
Quality Management Systems 2018-01-05T16:50:02+08:00

Quality management systems and licensing requirements for medical devices

The consultants at Andaman Medical will help you to implement customized processes to comply with the quality management system and licensing requirements in the ASEAN region.

Implemented in Singapore and Malaysia to date (yet to come for other member states), it is a requirement for ASEAN Importers, Distributors and Local Representatives to comply with Good Distribution Practices for Medical Devices. Andaman can support medical device companies with quality management systems and licensing requirements.

GDPMD specifies the requirements for a quality management system to be established, implemented and maintained by companies to comply with local regulatory requirements as stipulated in the Medical Devices Regulations. GDPMD requires an establishment to demonstrate its ability to maintain the quality, safety and performance of medical devices in compliance with the ASEAN medical device regulatory requirements throughout the supply-chain.

Our consultants will help you to implement adequate and customized processes to comply with the GDPMD requirements.

How to Launch a Medical Device in an ASEAN Market?

ASEAN regulations require that an establishment apply for a license before it can import, export or launch a registered medical device in the market. The application for an establishment license is made according to the requirements each ASEAN member state.

For example, in Malaysia, starting from 1 July 2013 when Act 737 came into effect, all establishments dealing with medical devices are required to apply for an Establishment License. Any company that has imported, exported or launched a medical device in the market prior to the effective date of the Act and intends to continue those activities are also required to apply for an Establishment License. It is usually only when an Establishment License is granted that a product can be registered.

Our Experienced Team is Here to Help!

Andaman Medical has qualified consultants who can help you navigate the necessary requirements to bring your product to market in Southeast Asia. They will assist you in obtaining and processing your Establishment License by acting as your Local Authorized Representative.

Quality Management & Licensing – FAQ

Quality Management Systems are used to demonstrate compliance with regulatory requirements. For example, ISO 13485 is often used to demonstrate compliance with the European Medical Devices Directive 93/42. Therefore it is important to implement a QMS that is aligned with your business objectives. For example, as a manufacturer, you might wish to sell your device in the United States, therefore the implementation of a quality system is required by law under the US FDA 21CFR part820.

“ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes” The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems and it is recognized by many countries in the world. ISO 13485 is a standalone standard that has been designed to support medical device manufacturers in implementing their QMS. The manufacturer shall establish a system addressing the following provisions:

  • Quality Management System (including documentation)
  • Management Responsibility
  • Resources Management
  • Product Realization
  • Measurement, Analysis and Improvement

Preparing for Your ISO13485 Certification or FDA Audit?

Andaman Medical has the professional staff to help with ISO13485 certification and FDA audits. Contact our qualified staff who are always ready to help.