Medical Device Regulatory Consulting

Helping Medical Device (Importers/Distributors) companies with ongoing QMS/GDPMD (Quality Management System & Good Distribution Practice for Medical Devices) compliance

Moody Consulting Pakistan has been helping medical device importers/distributors and manufacturers companies with regulatory compliance and establishment of license with registration of medical devices. After the implementation of the new Medical Devices rules S.R.O.32(1)/2018, medical device companies needed help obtaining GDPMD (Good Distribution Practice for Medical Devices) guidelines No  MDB/GD No 2, for importers/distributors & international manufacturers for their products in Pakistan.

Since then, we have become a leading consultancy company with more than 200 importers/distributors & international manufacturers and IVD clients all over Pakistan. We offering a wide range of compliance services, including regulatory strategy, device registration, quality management system compliance, and in-country regulatory representation. We offer our clients a single source for regulatory compliance help,

We, as a part of consultancy services like Dossier preparations & registration of Medical Devices.  We are currently working on a number of projects preparation of FORM 2 for Establishment of License to import medical devices in compliance with GDPMD (Good Distribution Practices Of Medical Devices) as per defined checklist of MDB and in line with registration of Medical Devices (FORM 7A) through the Drug Regulation Authority of Pakistan, All resulting in the product registrations and client satisfaction.  

We have qualified professional consultants, pharmacist and auditors to provide the quality of services in standards requirement,

Device Registration

Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to place devices on the market. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies.

Depending on where you plan to sell your device(s), successful registration may involve substantial effort to meet premarket technical and clinical submission requirements or leveraging your existing registrations and approvals to gain faster access to new markets.

Medical device registration support across all major markets

With offices worldwide, Emergo has helped medical device and IVD companies register their products in over 55 markets. Our consultants provide device registration and regulatory compliance expertise in established markets in Pakistan.