Peru Amends, Formalizes Medical Device Regulations
DIGEMID, Peru’s medical device market regulator, has published amendments to the country’s law covering pharmaceutical and device regulatory requirements that better reflect guidelines of the International Medical Device Regulators Forum, or IMDRF.
Announced through Decree No. D.S. 029-2015-SA (link in Spanish), the changes provide more specific criteria and data for new and modified device registrations, labeling requirements, terms and definitions, and violations and penalties.
Required device information for registration
Registration with DIGEMID will now require information including a device’s generic and brand names, risk classification, manufacturer’s home country and device grouping, as well as country or countries where the device’s manufacturing site is based.
Most of this information should be included on the DIGEMID registration applicant’s Certificate of Free Sale (CFS).
Major and minor registration changes
The new decree also establishes a more formal distinction between major and minor changes companies may wish to make to their Peru market registrations.
For minor registration changes, registrants must now only submit letters advising of those changes to the Peruvian National Authority of Pharmaceutical Products, Medical Devices and Sanitary Products (ANM), at which point such changes may be assumed to be in force. Following submission of a minor change letter, a registrant will have six months to implement said changes.
Examples of minor registration changes include commercial names and addresses of registration holders, names of technical directors and similar changes.
For major changes, registration holders must submit change requests to the ANM; the ANM will then issue authorization to the registrant to implement those changes within a six-month period. Submissions of major changes to ANM should include affidavit application forms and documents supporting proposed changes to a device.
Device packaging and labeling changes
DIGEMID has provided more specific instructions for device package labeling, as well. Imported medical devices packaged and shipped in single unit or kit packaging should include labeling information such as names and/or codes for devices or all components of kits; lot numbers and expiration dates; transportation and storage conditions; and intended use.
New terms and definitions
Finally, Peruvian regulators have developed more comprehensive definitions for terms such as “manufacturer,” “medical devices family,” “kit” and “set.” Further details regarding these definitions can be found in the new Decree.
Although Peru remains a relatively small medical device market, DIGEMID’s move to introduce more formalized and clear requirements for registration may result in more foreign manufacturers considering registration in the country.