In previous articles and guidelines, we have explained the registration process for medical devices in Mexico though the so called ordinary process and equivalency agreements, also known as fast-track processes. This time, we will go deeper into Japan equivalency agreement.
To clearly understand the requirements for the Japan equivalency agreement, first we need to know the general classification and authorization process for medical devices in Japan.
Medical devices in Japan are classified into four categories (Class I-IV) according to their risk –similarly as with Canada or Europe.
Furthermore, medical devices are divided as:
- General Class I (extremely low risk)
- Specified Controlled Class II (low risk)
- Controlled Class II (medium risk)
- Highly Controlled Class III (high risk)
- Highly Controlled Class IV (life-threatening risk)
The authorization process for medical devices in Japan is complex, but can be summarized with the type of authorization needed for each class:
- General Class I – self declaration, notification to Pharmaceuticals and Medical Devices Agency (PMDA)
- Specified Controlled Class II – Pre-market certification issued by a Registered Certification Body (RCB)
- Controlled Class II, Highly Controlled Class III and Highly Controlled Class IV – Pre-market Approval Certificate issued by the Ministry of Health, Labor and Welfare (MHLW)
Requirements for Japan Equivalency Agreement
Once mentioned how medical devices are approved in Japan, we can skip to the requirements for registering your products taking advantage of this process. It is worth mentioning that General Class I devices are not considered in the Japan equivalency agreement for Mexico. That being said for those medical devices considered in Japan as Class II, III or IV, the requirements in Mexico are:
- Pre-market certification issued by RCB or Pre-market Approval Certificate issued by the MHLW.
- Notification of Exportation
- Free Sale Certificate
It is important to mention that the Pre-market certification issued by a RCB or Pre-market Approval Certificate issued by the MHLW contains, when applicable:
- Indication of use
Finally, the manufacturer must provide the Notification of Exportation and Free Sale Certificate that are similar but not the same. All these legal documentation must be apostilled in Japan.
If you have additional questions or doubts for registering your medical devices in Mexico with the aid of the equivalency agreement process of Japan, please contact us at firstname.lastname@example.org or check our guidelines.