Services – Nord Pacific Medical

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Regulatory Services

Medical Device Registration

Get your medical devices on the market hassle-free with our comprehensive regulatory support.

Whether your products are domestically manufactured or imported, navigating the diverse landscape of national regulatory authorities is crucial. Each country boasts its own unique registration process, classification criteria, and requirements. There would also be different requirements for registration fees, timelines, and validity of clearance certificates.

As these processes could be long, tedious and complex, strategic planning is essential. That’s where we come in. Our experts can guide you through the process, making sure you comply with regulations and stay in the East Asian market for the long haul.

Local Authorised Representative

What is Local Authorized Representative?

The local authorised representative (LAR), also known as the in-country representative, local agent, or marketing authorization holder, acts on behalf of the foreign manufacturer in all interactions with local medical device authorities.

Simply put, they will be your regulatory point of contact in the country you’re looking to expand into.

Why are they vital for your expansion?

Here’s what they’ll do for you:

Handle all interactions with local medical device authorities, including registering the product, obtaining import and distribution licenses, submitting change notifications, transferring product licenses, and managing post-market surveillance activities such as adverse events and product recalls.
Ensure the appropriate conformity assessment procedure has been conducted if required, and that the device is correctly labeled in the specified national language(s).
Handle all communications with the local medical device authority regarding the foreign manufacturer and its products.
Maintain a business presence within the country throughout the agreement term.
Assist with complaint handling and monitor regulations to alert the manufacturer to any changes or new regulations applicable to their product.

Post Market Surveillance

Local appointed dealers, also known as economic operators, work hand in hand with manufacturers to maintain the quality, safety and effectiveness of the device. It is also their purview to consistently supervise checking the devices in circulation with the aim to protect users and patients.

Why is post-market surveillance important?

To collect and assess real-world data from medical devices in use.
To guarantee ongoing safety and performance of medical devices.
To prompt action if risks outweigh benefits.
To identify areas for enhancing medical device functionality.

Intelligence Reports

Regulatory groundwork and due diligence are vital before you dive into selling and marketing your product in a new, unfamiliar market. But here’s the thing, whether it’s for a device already registered elsewhere but similar to others in the target country, or a completely new product, understanding the regulatory landscape can be overwhelming.

A regulatory intelligence report is important in this stage as it can guide you through all the regulatory challenges of bringing your product to market. It covers everything from checking document compliance and identifying gaps to understanding labeling and testing needs, as well as obtaining market access licenses and exploring fast-track authorization options.

What is included in a regulatory report?

Regulatory classification of the medical device or IVD.
Reference of all applicable legislation.
Body/bodies responsible for legislation(s) in the market, for example the product may require telecommunications licenses for wifi, Bluetooth and other connected devices, devices containing drug products and controlled substances.
Details of the process for registration, change notifications or license transfers and timescales.
Cost (fees) of registration, change notification or license transfer.
Labeling requirements.
Testing requirements related to product registration:
1. Any tests that must be completed (in vitro or in vivo).
2. By whom they need to be carried out.
3. To which standards.
Potential issues / claims that could impact the regulatory classification.
Market access requirements such as appointing a Local Authorized Representative, restrictions on imports/exports, customs and duties.
Fast track market authorizations that may exist in the target market, with specific timelines and specifications on any temporary status and controls.
Post-market surveillance requirements.

Get compliance where and when you need it.

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