The Andhra Pradesh MedTech Zone (AMTZ), Vizag headed a pioneering meet up of WHO in the Medical Device &Diagnostic domains as a part of the South-East Asian Regulatory Network (SEARN).

The day long program had attendees from delegates from seven South East Asian Regulatory bodies namely, Bhutan, Nepal, Bangladesh, Sri Lanka, Maldives, Thailand and Timor-Leste.

WHO representatives from the India country office as well as the headquarters in Geneva also presented their perspectives. National Biological Institute and the Central Drug Standards Control General’s office were also part of the event. The key areas of discussion and deliberations were Regulation, Vigilance and Price Control.

Welcoming the representatives of various countries, Dr Jitendar Sharma, MD&CEO, AMTZ, elucidated the role AMTZ has played in the regulatory framework in India. He spoke about the WHO guidelines for pre-qualification in In-Vitro Diagnostics that are being adapted at AMTZ along with vaccines in drugs thus enabling manufacturers of medical devices on pan India to access UN markets. He also offered to be of help to all the countries with the repository of experience that AMTZ and its group of institutions have in the field of medical technology.

The South-East Asian delegates mentioned of their dependency on import, almost at 100%, where a framework proposed by AMTZ can also help access regulatory approvals, which in turn can help access universal healthcare success.

Dr. Poonam Malakondaiah expressed hope that these deliberations would lead to a better regulatory framework that wouldn’t stifle but augment the production of medical devices which would aid in tackling diseases at much faster pace.

Regulators from different countries have shared the regulatory frame work in their respective countries and the issues that they are facing as far as medical devices are concerned.

Dr Manisha Shridhar, regional adviser appreciated the viewpoints of representatives from all the countries and assured that this working group will find solutions that could be helpful in achieving public health goals of various countries. She underlined the fact that different countries are at different stages as far as regulation of medical devices is concerned and understanding various standpoints and addressing them would lead to a better regulatory framework across the board. 

Dr Madhur Gupta, WHO, India office underlined the need for standardization of medical device regulatory framework and assist smaller countries in building the regulatory capacity. She also took the participants through the work done by WHO towards achieving this goal.

AMTZ recently headed a meet up of WHO in the Medical Device & Diagnostic domains as part of the South-East Asian Regulatory Network (SEARN).